<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04482036</url>
  </required_header>
  <id_info>
    <org_study_id>1907055854</org_study_id>
    <secondary_id>1K23AG059914-01A1</secondary_id>
    <nct_id>NCT04482036</nct_id>
  </id_info>
  <brief_title>The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD (MOMENT) Study</brief_title>
  <acronym>MOMENT</acronym>
  <official_title>The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic Mild Cognitive Impairment and Alzheimer's Disease (MOMENT) Study: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to learn whether it is possible and useful for&#xD;
      caregivers to report behavioral or psychological symptoms of people with mild memory problems&#xD;
      or Alzheimer's disease through a smartphone mobile application. The investigators believe&#xD;
      that monitoring these symptoms and having a tool, like a mobile application, can provide&#xD;
      quicker accessibility to the patient's clinical care team, which could improve care for&#xD;
      patients and caregivers.&#xD;
&#xD;
      These types of symptoms found in patients with mild memory problems or Alzheimer's disease&#xD;
      are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of&#xD;
      these brain illnesses. Examples of psychological and behavioral symptoms are depression,&#xD;
      anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from&#xD;
      regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's&#xD;
      disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can&#xD;
      lead to greater use of healthcare services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a part of this research study the patient and caregiver will undergo randomization, &quot;like&#xD;
      flipping a coin&quot;, to assign the patient and caregiver to one of two research study groups.&#xD;
      The patient and the partnered caregiver will join the same group. The group will either&#xD;
      receive: 1) three in-person assessments on symptoms and behaviors that the patient may&#xD;
      experience and a mobile application that will send surveys to the caregiver in order to rate&#xD;
      the presence, severity and stress caused by these symptoms and behaviors; or 2) three&#xD;
      in-person assessments on symptoms and behaviors that the patient may experience and no mobile&#xD;
      application. The outcomes of these surveys and assessments will then be shared with the&#xD;
      patient's clinical team.&#xD;
&#xD;
      If the caregiver is assigned to the group that receives the mobile application they will&#xD;
      receive the surveys either weekly or monthly. After each month of completing the surveys, the&#xD;
      frequency will change. Depending on feedback from the first 10 participants, the&#xD;
      investigators may modify the survey rate to happen more than weekly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The Principle Investigator changed careers and relinquished their NIA funded career development&#xD;
    award, which funded the MOMENT Study. Career development awards are not transferable. Thus, the&#xD;
    study was terminated prematurely.&#xD;
  </why_stopped>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Actual">October 4, 2021</completion_date>
  <primary_completion_date type="Actual">October 4, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study design includes six 1-month periods. Those in the intervention group will be nested in a 2 x 6 cross-over design in which they will be randomly assigned to start with 1 of 2 schedules of Ecological Momentary Assessment (EMA) surveillance frequency (1) weekly or (2) monthly. The intervention participants will then cross-over at the end of each and every month to the other surveillance frequency condition, over a 6-month time horizon.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The principal investigator will be masked to arm allocation of participants. The outcomes assessor at time of 3 month and 6 month (final) assessment will also be masked to the allocation of participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months</measure>
    <time_frame>Calculated at 3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months</measure>
    <time_frame>Calculated at 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months</measure>
    <time_frame>Calculated at 3 months</time_frame>
    <description>Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, &quot;Dementia Collaborative Care- Caregivers&quot; did not utilize the BrainCare Notes application.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months</measure>
    <time_frame>Calculated at 6 months</time_frame>
    <description>Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, &quot;Dementia Collaborative Care- Caregivers&quot; did not utilize the BrainCare Notes application.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint</measure>
    <time_frame>Measured at 3 months</time_frame>
    <description>The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.</measure>
    <time_frame>Measured at 6 months</time_frame>
    <description>The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 3 months</time_frame>
    <description>The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 6 months</time_frame>
    <description>The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 3 months</time_frame>
    <description>The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 6 months</time_frame>
    <description>The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 3 months</time_frame>
    <description>The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4&quot; Very often.&quot; Total scores range from 0 to 56 with a higher score indicating greater perceived stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 6 months</time_frame>
    <description>The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4&quot; Very often.&quot; Total scores range from 0 to 56 with a higher score indicating greater perceived stress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 3 months</time_frame>
    <description>The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, &quot;0 - Never&quot; to &quot;4 - Nearly Always.&quot; Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</measure>
    <time_frame>Calculated at 6 months</time_frame>
    <description>The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, &quot;0 - Never&quot; to &quot;4 - Nearly Always.&quot; Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Alzheimer Disease</condition>
  <condition>Mild Memory Disturbance</condition>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Dementia Collaborative Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dementia Collaborative Care Plus BrainCare Notes Application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Phone Application Assessments</intervention_name>
    <description>The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.</description>
    <arm_group_label>Dementia Collaborative Care Plus BrainCare Notes Application</arm_group_label>
    <other_name>BrainCare Notes app</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Assessments</intervention_name>
    <description>The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
    <arm_group_label>Dementia Collaborative Care</arm_group_label>
    <arm_group_label>Dementia Collaborative Care Plus BrainCare Notes Application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient:&#xD;
&#xD;
               -  Has Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (aMCI), is a&#xD;
                  Healthy Aging Brain Center, Eskenazi Health patient&#xD;
&#xD;
               -  Community dwelling&#xD;
&#xD;
               -  Has a legally authorized representative when they lack capacity to consent&#xD;
&#xD;
          -  The caregiver:&#xD;
&#xD;
               -  18 or older&#xD;
&#xD;
               -  No visual impairment&#xD;
&#xD;
               -  Community dwelling&#xD;
&#xD;
               -  Reports seeing patient most days of the week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patient:&#xD;
&#xD;
               -  History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)&#xD;
&#xD;
               -  Participating in another study&#xD;
&#xD;
               -  The potential participant with a diagnosis of either aMCI or AD communicates&#xD;
                  observable dissent.&#xD;
&#xD;
          -  The caregiver:&#xD;
&#xD;
               -  History of mental illness (Schizoaffective disorder, schizophrenia, bipolar)&#xD;
&#xD;
               -  Participating in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel R Bateman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eskenazi Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <results_first_submitted>February 13, 2023</results_first_submitted>
  <results_first_submitted_qc>August 9, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2023</results_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Chris Callahan, MD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Patient Distress</keyword>
  <keyword>Caregiver Burden</keyword>
  <keyword>Caregiver Stress</keyword>
  <keyword>Mobile Phone Application</keyword>
  <keyword>Psychological Symptoms</keyword>
  <keyword>Behavioral Symptoms</keyword>
  <keyword>Behavioral and Psychological Symptoms of Dementia</keyword>
  <keyword>Neuropsychiatric Symptoms</keyword>
  <keyword>mHealth</keyword>
  <keyword>Mobile Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 20, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT04482036/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dementia Collaborative Care - Patients</title>
          <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="P2">
          <title>Dementia Collaborative Care - Caregivers</title>
          <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="P3">
          <title>Dementia Collaborative Care Plus BrainCare Notes Application - Patients</title>
          <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="P4">
          <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
          <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dementia Collaborative Care - Patients</title>
          <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="B2">
          <title>Dementia Collaborative Care - Caregivers</title>
          <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="B3">
          <title>Dementia Collaborative Care Plus BrainCare Notes Application - Patients</title>
          <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="B4">
          <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
          <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78.2" lower_limit="68" upper_limit="87"/>
                    <measurement group_id="B2" value="64.4" lower_limit="45" upper_limit="88"/>
                    <measurement group_id="B3" value="78.2" lower_limit="70" upper_limit="84"/>
                    <measurement group_id="B4" value="70.6" lower_limit="43" upper_limit="85"/>
                    <measurement group_id="B5" value="72.85" lower_limit="43" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months</title>
        <time_frame>Calculated at 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control - Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months</title>
        <time_frame>Calculated at 6 months</time_frame>
        <population>The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months</title>
          <population>The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months</title>
        <description>Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, &quot;Dementia Collaborative Care- Caregivers&quot; did not utilize the BrainCare Notes application.</description>
        <time_frame>Calculated at 3 months</time_frame>
        <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only 4 randomized participants who reached this time point before the study was terminated.</population>
        <group_list>
          <group group_id="O1">
            <title>Control- Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months</title>
          <description>Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, &quot;Dementia Collaborative Care- Caregivers&quot; did not utilize the BrainCare Notes application.</description>
          <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only 4 randomized participants who reached this time point before the study was terminated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months</title>
        <description>Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, &quot;Dementia Collaborative Care- Caregivers&quot; did not utilize the BrainCare Notes application.</description>
        <time_frame>Calculated at 6 months</time_frame>
        <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only two randomized participants that reached the 6 month time point before the study was terminated.</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months</title>
          <description>Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, &quot;Dementia Collaborative Care- Caregivers&quot; did not utilize the BrainCare Notes application.</description>
          <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. There were only two randomized participants that reached the 6 month time point before the study was terminated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint</title>
        <description>The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5</description>
        <time_frame>Measured at 3 months</time_frame>
        <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before the other participant reached the 3 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint</title>
          <description>The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5</description>
          <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before the other participant reached the 3 month time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.</title>
        <description>The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5</description>
        <time_frame>Measured at 6 months</time_frame>
        <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Control - Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Randomized - Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.</title>
          <description>The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5</description>
          <population>This outcome measure is designated only to participants in the randomized group, therefore there are zero participants in the control group that completed this survey. The study was terminated before other participants reached the 6 month time point. Two caregivers reached the 6 month time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
        <description>The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.</description>
        <time_frame>Calculated at 3 months</time_frame>
        <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
          <description>The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.</description>
          <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" lower_limit="-4" upper_limit="7"/>
                    <measurement group_id="O2" value="1" lower_limit="-7" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
        <description>The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.</description>
        <time_frame>Calculated at 6 months</time_frame>
        <population>The study was terminated before the other participants were able to complete this survey at the 6 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
          <description>The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.</description>
          <population>The study was terminated before the other participants were able to complete this survey at the 6 month time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6" lower_limit="2" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
        <description>The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.</description>
        <time_frame>Calculated at 3 months</time_frame>
        <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before reaching this time point.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
          <description>The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.</description>
          <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before reaching this time point.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" lower_limit="-4" upper_limit="7"/>
                    <measurement group_id="O2" value="4.25" lower_limit="-11" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
        <description>The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.</description>
        <time_frame>Calculated at 6 months</time_frame>
        <population>The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
          <description>The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.&#xD;
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.</description>
          <population>The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-3.5" lower_limit="-9" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
        <description>The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4&quot; Very often.&quot; Total scores range from 0 to 56 with a higher score indicating greater perceived stress.</description>
        <time_frame>Calculated at 3 months</time_frame>
        <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected because the study was terminated.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
          <description>The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4&quot; Very often.&quot; Total scores range from 0 to 56 with a higher score indicating greater perceived stress.</description>
          <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected because the study was terminated.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" lower_limit="-7" upper_limit="6"/>
                    <measurement group_id="O2" value="-3.67" lower_limit="-6" upper_limit="-1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
        <description>The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4&quot; Very often.&quot; Total scores range from 0 to 56 with a higher score indicating greater perceived stress.</description>
        <time_frame>Calculated at 6 months</time_frame>
        <population>The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
          <description>The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - &quot;Never&quot; to 4&quot; Very often.&quot; Total scores range from 0 to 56 with a higher score indicating greater perceived stress.</description>
          <population>The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
        <description>The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, &quot;0 - Never&quot; to &quot;4 - Nearly Always.&quot; Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.</description>
        <time_frame>Calculated at 3 months</time_frame>
        <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before the time point was reached.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.</title>
          <description>The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, &quot;0 - Never&quot; to &quot;4 - Nearly Always.&quot; Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.</description>
          <population>There were 2 patients from the control group (dementia collaborative care arm) that passed away before the 3 month period was met, therefore the outcome wasn't collected from the caregivers. Data from the remaining participants wasn't collected as the study was terminated before the time point was reached.&#xD;
The study was terminated before the other participant reached the 3 month time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="-5" upper_limit="8"/>
                    <measurement group_id="O2" value="0" lower_limit="-6" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
        <description>The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, &quot;0 - Never&quot; to &quot;4 - Nearly Always.&quot; Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.</description>
        <time_frame>Calculated at 6 months</time_frame>
        <population>The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Dementia Collaborative Care - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
          <group group_id="O2">
            <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
            <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
          </group>
        </group_list>
        <measure>
          <title>Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.</title>
          <description>The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, &quot;0 - Never&quot; to &quot;4 - Nearly Always.&quot; Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.</description>
          <population>The study was terminated before other participants reached the 6 month time point. Only two caregivers reached the 6 month time point, data from the remaining participants wasn't collected.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1" lower_limit="-2" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dementia Collaborative Care - Patients</title>
          <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="E2">
          <title>Dementia Collaborative Care - Caregivers</title>
          <description>Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:&#xD;
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.&#xD;
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.&#xD;
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.&#xD;
If the patient's &quot;symptoms&quot; or the caregiver's &quot;distress&quot; answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.&#xD;
The research study team will also notify Dr. Bateman (the person responsible for the research).&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="E3">
          <title>Dementia Collaborative Care Plus BrainCare Notes Application - Patients</title>
          <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
        <group group_id="E4">
          <title>Dementia Collaborative Care Plus BrainCare Notes Application - Caregivers</title>
          <description>Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:&#xD;
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.&#xD;
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.&#xD;
Mobile Phone Application Assessments: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.&#xD;
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.&#xD;
Standard Assessments: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Bilateral pulmonary embolism</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pacemaker insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated [The Principle Investigator changed careers and relinquished their NIA funded career development award, which funded the MOMENT Study. Career development awards are not transferable. Thus, the study was terminated prematurely.]</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jessica Broughton</name_or_title>
      <organization>Eskenazi Health</organization>
      <phone>317-903-6276</phone>
      <email>jessica.broughton@eskenazihealth.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04482036
org study id: 1907055854
secondary id: 1K23AG059914-01A1
nct id: NCT04482036
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to learn whether it is possible and useful for
      caregivers to report behavioral or psychological symptoms of people with mild memory problems
      or Alzheimer's disease through a smartphone mobile application. The investigators believe
      that monitoring these symptoms and having a tool, like a mobile application, can provide
      quicker accessibility to the patient's clinical care team, which could improve care for
      patients and caregivers.

      These types of symptoms found in patients with mild memory problems or Alzheimer's disease
      are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of
      these brain illnesses. Examples of psychological and behavioral symptoms are depression,
      anxiety, insomnia, irritability, agitation, and hallucinations. These symptoms differ from
      regular psychiatric symptoms, because they are caused by mild memory problems or Alzheimer's
      disease (AD). These symptoms can cause a lot of distress for patients and caregivers, and can
      lead to greater use of healthcare services.
As a part of this research study the patient and caregiver will undergo randomization, "like
      flipping a coin", to assign the patient and caregiver to one of two research study groups.
      The patient and the partnered caregiver will join the same group. The group will either
      receive: 1) three in-person assessments on symptoms and behaviors that the patient may
      experience and a mobile application that will send surveys to the caregiver in order to rate
      the presence, severity and stress caused by these symptoms and behaviors; or 2) three
      in-person assessments on symptoms and behaviors that the patient may experience and no mobile
      application. The outcomes of these surveys and assessments will then be shared with the
      patient's clinical team.

      If the caregiver is assigned to the group that receives the mobile application they will
      receive the surveys either weekly or monthly. After each month of completing the surveys, the
      frequency will change. Depending on feedback from the first 10 participants, the
      investigators may modify the survey rate to happen more than weekly.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study design includes six 1-month periods. Those in the intervention group will be nested in a 2 x 6 cross-over design in which they will be randomly assigned to start with 1 of 2 schedules of Ecological Momentary Assessment (EMA) surveillance frequency (1) weekly or (2) monthly. The intervention participants will then cross-over at the end of each and every month to the other surveillance frequency condition, over a 6-month time horizon.
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
masking description: The principal investigator will be masked to arm allocation of participants. The outcomes assessor at time of 3 month and 6 month (final) assessment will also be masked to the allocation of participants.
measure: Number of Caregivers Who Completed Neuropsychiatric Interview Questionnaire (NPI-Q) at 3 Months
time frame: Calculated at 3 months
measure: Number of Caregivers Who Completed the Neuropsychiatric Interview Questionnaire (NPI-Q) at 6 Months
time frame: Calculated at 6 months
measure: Number of Caregivers Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 3 Months
time frame: Calculated at 3 months
description: Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application.
measure: Number of Participants Who Completed the BrainCare Notes (BCN) App - Survey Burden Mean at 6 Months
time frame: Calculated at 6 months
description: Randomized participants are prompted to answer the survey burden question after completion of each BCN app prompted survey. The caregivers in the control group, "Dementia Collaborative Care- Caregivers" did not utilize the BrainCare Notes application.
measure: Number of Participants Who Completed the System Usability Scale (SUS) at the 3 Month Timepoint
time frame: Measured at 3 months
description: The System Usability Scale will be used to assess usability of the BrainCare Notes app at 3 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
measure: Number of Participants Who Completed the System Usability Scale (SUS) at the 6 Month Timepoint.
time frame: Measured at 6 months
description: The System Usability Scale (SUS) will be used to assess usability of the BrainCare Notes app at 6 months. Only the randomized participants will be completing this survey. The scale is as follows: Strongly Disagree-1, Disagree- 2, Neutral- 3, Agree- 4, Strongly Agree- 5
measure: Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
time frame: Calculated at 3 months
description: The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.
measure: Outcome of the Change in Behavioral and Psychological Symptoms (BPSD) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
time frame: Calculated at 6 months
description: The NPI-Q is a questionnaire administered to a caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.
Symptom severity scores for each of the symptom domain range between 0-not present, 1 - mild, 2-moderate, 3-severe. The summation of all symptom severity scores have a range of a minimum score of 0 and maximum score of 36, where the higher the number indicates worse symptom severity.
measure: Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
time frame: Calculated at 3 months
description: The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.
measure: Outcome of the Change in Caregiver Distress Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
time frame: Calculated at 6 months
description: The NPI-Q is a questionnaire administered to the caregiver who cares for a person with mild cognitive impairment (MCI), Alzheimer's disease (AD) or dementia.
The Caregiver Distress scores for each of the symptom domain range between: 0 = Not distressing at all, 1 = Minimal, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Extreme or Very Severe. The summation of all the Caregiver Distress scores ranges from a min score of 0 and max score of 60, where the higher the number indicates worse Caregiver Distress severity.
measure: Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
time frame: Calculated at 3 months
description: The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress.
measure: Outcome of the Change in the Perceived Stress Scale 14 (PSS-14) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
time frame: Calculated at 6 months
description: The PSS-14 is a validated self-reported questionnaire comprised of 14 items designed to assess stress and coping. Participants rate items on a 5-point Likert scale, ranging from 0 - "Never" to 4" Very often." Total scores range from 0 to 56 with a higher score indicating greater perceived stress.
measure: Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 3 Months From What Was Reported at Baseline.
time frame: Calculated at 3 months
description: The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.
measure: Outcome of the Change in the Zarit Burden Interview (ZBI-12) Score- Specifically Any Change Seen at 6 Months From What Was Reported at Baseline.
time frame: Calculated at 6 months
description: The ZBI-12 is a validated, caregiver self-report measure comprised of 12 items designed to assess caregiver burden in those who care for patients with advanced illness, including dementia. Participants rate items on a 5-point Likert scale, ranging from, "0 - Never" to "4 - Nearly Always." Total scores range from 0 to 48 with a higher score indicating greater caregiver burden.
arm group label: Dementia Collaborative Care
arm group type: Placebo Comparator
description: Patient and caregivers assigned to the three in-person assessments and no mobile application group will complete the following:
The caregiver will be asked to complete three in-person assessments that involve answering survey questions and an interview.
Some of the questions asked will be related to Behavioral and/or Psychological Symptoms the patient experiences.
The caregiver will be asked to answer questions about the patient, the patient's experience with the research study and the caregiver's own experience with the research study.
If the patient's "symptoms" or the caregiver's "distress" answers reach a high enough level, a member of the research study team and clinical team will contact the caregiver to ask more questions and check in on the patient and caregiver's safety.
The research study team will also notify Dr. Bateman (the person responsible for the research).
arm group label: Dementia Collaborative Care Plus BrainCare Notes Application
arm group type: Active Comparator
description: Patient and caregivers assigned to the three in-person assessments and mobile application group will complete the same tasks that Group 1 (control group) will complete with the addition of the following:
The caregiver will be asked to monitor the patient and complete 5 to 10-minute long surveys (the neuropsychiatric inventory questionnaire) sent to the caregiver through the mobile application or in-person at each follow-up visit.
The caregiver will be asked to monitor and complete these surveys at different times for a period of 6 months.
intervention type: Other
intervention name: Mobile Phone Application Assessments
description: The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.
The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team.
arm group label: Dementia Collaborative Care Plus BrainCare Notes Application
other name: BrainCare Notes app
intervention type: Other
intervention name: Standard Assessments
description: The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.
arm group label: Dementia Collaborative Care
arm group label: Dementia Collaborative Care Plus BrainCare Notes Application
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel R Bateman, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Chris Callahan, MD
investigator title: Professor of Medicine
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated [The Principle Investigator changed careers and relinquished their NIA funded career development award, which funded the MOMENT Study. Career development awards are not transferable. Thus, the study was terminated prematurely.]
point of contact: 