<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/NCT03300180</url>
  </required_header>
  <id_info>
    <org_study_id>1705649205</org_study_id>
    <secondary_id>5R01AG056325-05</secondary_id>
    <nct_id>NCT03300180</nct_id>
  </id_info>
  <brief_title>Caregiver Outcomes of Alzheimer's Disease Screening</brief_title>
  <acronym>COADS</acronym>
  <official_title>Caregiver Outcomes of Alzheimer's Disease Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will measure the risks and benefits of early screening of Alzheimer's disease.&#xD;
      Early diagnosis through screening may enhance the family member's transition to a family&#xD;
      caregiver and reduce caregiver burden by providing an opportunity for the family member to&#xD;
      learn about the syndrome, receive interventions, and to prepare for their new care giving&#xD;
      role.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We are proposing the first randomized controlled trial (RCT) to evaluate the benefits and&#xD;
      harms of AD screening on family members of older adults. The proposed trial will randomize&#xD;
      1,800 dyads (older adult and family member) into three groups. Older adults in the first&#xD;
      group will be screened for AD at baseline coupled with disclosure of the screening results to&#xD;
      the dyad and to the patient's primary care provider (Screening Only Group). Older adults in&#xD;
      the second group will be screened for AD at baseline coupled with disclosure of the screening&#xD;
      results and, if they screen positive, referred to the Aging Brain Care (ABC) Program for&#xD;
      diagnostic evaluation and care, if AD is diagnosed (Screening Plus Group). Older adults in&#xD;
      the third group will not be screened at baseline and will observed through surveillance of&#xD;
      the patients' EHR for any screening or incident AD diagnoses that occurs as part of routine&#xD;
      care. At the last follow-up assessment (24 months) we will we will screen the older adults&#xD;
      and conduct an interview with the family caregiver to detect possible cognitive impairment&#xD;
      (Control Group).&#xD;
&#xD;
      Specific Aim 1: Evaluate the impact of AD screening on family members' quality of life.&#xD;
&#xD;
      Hypothesis 1: In comparison to the control group, family members randomized to the screening&#xD;
      only or the screening plus groups will express higher levels of health-related quality of&#xD;
      life at 24 months as measured by the Short Form Health Survey (SF-36).&#xD;
&#xD;
      Specific Aim 2: Evaluate the impact of AD screening on family members' mood and anxiety.&#xD;
&#xD;
      Hypothesis 2: In comparison to the control group, family members randomized to the screening&#xD;
      only or the screening plus groups will express lower rates of depressive and anxiety symptoms&#xD;
      at 24 months as measured by the Patient Health Questionnaire (PHQ-9) and the Generalized&#xD;
      Anxiety Disorder Scale (GAD-7).&#xD;
&#xD;
      Specific Aim 3: Assess the impact of AD screening on family members' caregiving preparedness&#xD;
      and caregiving self-efficacy.&#xD;
&#xD;
      Hypothesis 3: In comparison to the control group, family members randomized to the screening&#xD;
      only or the screening plus group, will be more prepared for caregiving and have higher&#xD;
      self-efficacy at 24 months as measured by the Preparedness for Caregiving Scale and the&#xD;
      Revised Scale for Caregiving Self-Efficacy.&#xD;
&#xD;
      Specific Aim 4: Compare the effectiveness of two strategies for diagnostic evaluation and&#xD;
      management after AD screening.&#xD;
&#xD;
      Hypothesis 4: In comparison to the screening only group, family members randomized to the&#xD;
      screening plus group will express higher levels of health-related quality of life, caregiver&#xD;
      preparedness and caregiving self-efficacy and lower levels of depressive and anxiety symptoms&#xD;
      at 24 months, as measured by the SF-36, Preparedness for Caregiving Scale, the Revised Scale&#xD;
      for Caregiving Self-Efficacy, PHQ-9, and GAD-7, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 15, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</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>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Form Health Survey (SF-36)</measure>
    <time_frame>24 month</time_frame>
    <description>Multi-level mixed effects models will be used to examine differences in SF-36 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated SF-36 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>24 month</time_frame>
    <description>The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms</measure>
    <time_frame>24 month</time_frame>
    <description>The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiving preparedness</measure>
    <time_frame>24 month</time_frame>
    <description>The investigators will use the Preparedness for Caregiving Scale to measure the impact of ADRC screening on family member preparedness. The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiving self efficacy</measure>
    <time_frame>24 month</time_frame>
    <description>The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3734</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients in this group will receive no AD screening</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Screening Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Collaborative Dementia Care Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Collaborative Dementia Care Program</intervention_name>
    <description>Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.</description>
    <arm_group_label>Collaborative Dementia Care Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening Only</intervention_name>
    <description>The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening</description>
    <arm_group_label>Screening Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  65 years or older&#xD;
&#xD;
          -  At least one visit to primary care practice within past 24 months&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Ability to communicate in English&#xD;
&#xD;
        Family Members&#xD;
&#xD;
          -  21 years or older&#xD;
&#xD;
          -  Identified by the patient as the person most likely to provide them care if needed.*&#xD;
&#xD;
          -  Lives with the patient or lives within a 50 mile radius.&#xD;
&#xD;
          -  Ability to provide informed consent.&#xD;
&#xD;
          -  Ability to communicate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  Has a diagnosis of AD as determined by ICD-10 code.&#xD;
&#xD;
          -  Evidence of a prescription for a cholinesterase inhibitors or memantine.&#xD;
&#xD;
          -  Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10&#xD;
             code&#xD;
&#xD;
          -  Permanent resident of a nursing facility&#xD;
&#xD;
          -  Already seen by the Healthy Aging Brain Care Program&#xD;
&#xD;
        Family Member&#xD;
&#xD;
          -  Is a non-family member who is not a legal Healthcare Power of Attorney&#xD;
&#xD;
          -  Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10&#xD;
             code&#xD;
&#xD;
          -  Has a diagnosis of AD as determined by ICD-10 code.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Fowler, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eskenazi Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health-Primary Care Clinics</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>February 2023</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Nicole R. Fowler, PhD</investigator_full_name>
    <investigator_title>Scientist, Indiana University Center for Aging Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03300180
org study id: 1705649205
secondary id: 5R01AG056325-05
nct id: NCT03300180
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will measure the risks and benefits of early screening of Alzheimer's disease.
      Early diagnosis through screening may enhance the family member's transition to a family
      caregiver and reduce caregiver burden by providing an opportunity for the family member to
      learn about the syndrome, receive interventions, and to prepare for their new care giving
      role.
We are proposing the first randomized controlled trial (RCT) to evaluate the benefits and
      harms of AD screening on family members of older adults. The proposed trial will randomize
      1,800 dyads (older adult and family member) into three groups. Older adults in the first
      group will be screened for AD at baseline coupled with disclosure of the screening results to
      the dyad and to the patient's primary care provider (Screening Only Group). Older adults in
      the second group will be screened for AD at baseline coupled with disclosure of the screening
      results and, if they screen positive, referred to the Aging Brain Care (ABC) Program for
      diagnostic evaluation and care, if AD is diagnosed (Screening Plus Group). Older adults in
      the third group will not be screened at baseline and will observed through surveillance of
      the patients' EHR for any screening or incident AD diagnoses that occurs as part of routine
      care. At the last follow-up assessment (24 months) we will we will screen the older adults
      and conduct an interview with the family caregiver to detect possible cognitive impairment
      (Control Group).

      Specific Aim 1: Evaluate the impact of AD screening on family members' quality of life.

      Hypothesis 1: In comparison to the control group, family members randomized to the screening
      only or the screening plus groups will express higher levels of health-related quality of
      life at 24 months as measured by the Short Form Health Survey (SF-36).

      Specific Aim 2: Evaluate the impact of AD screening on family members' mood and anxiety.

      Hypothesis 2: In comparison to the control group, family members randomized to the screening
      only or the screening plus groups will express lower rates of depressive and anxiety symptoms
      at 24 months as measured by the Patient Health Questionnaire (PHQ-9) and the Generalized
      Anxiety Disorder Scale (GAD-7).

      Specific Aim 3: Assess the impact of AD screening on family members' caregiving preparedness
      and caregiving self-efficacy.

      Hypothesis 3: In comparison to the control group, family members randomized to the screening
      only or the screening plus group, will be more prepared for caregiving and have higher
      self-efficacy at 24 months as measured by the Preparedness for Caregiving Scale and the
      Revised Scale for Caregiving Self-Efficacy.

      Specific Aim 4: Compare the effectiveness of two strategies for diagnostic evaluation and
      management after AD screening.

      Hypothesis 4: In comparison to the screening only group, family members randomized to the
      screening plus group will express higher levels of health-related quality of life, caregiver
      preparedness and caregiving self-efficacy and lower levels of depressive and anxiety symptoms
      at 24 months, as measured by the SF-36, Preparedness for Caregiving Scale, the Revised Scale
      for Caregiving Self-Efficacy, PHQ-9, and GAD-7, respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
measure: Short Form Health Survey (SF-36)
time frame: 24 month
description: Multi-level mixed effects models will be used to examine differences in SF-36 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated SF-36 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.
measure: Depressive symptoms
time frame: 24 month
description: The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27.
measure: Anxiety symptoms
time frame: 24 month
description: The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21.
measure: Caregiving preparedness
time frame: 24 month
description: The investigators will use the Preparedness for Caregiving Scale to measure the impact of ADRC screening on family member preparedness. The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels.
measure: Caregiving self efficacy
time frame: 24 month
description: The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).
arm group label: Control
arm group type: No Intervention
description: The patients in this group will receive no AD screening
arm group label: Screening Only
arm group type: Active Comparator
description: The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.
arm group label: Collaborative Dementia Care Program
arm group type: Experimental
description: The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
intervention type: Behavioral
intervention name: Collaborative Dementia Care Program
description: Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
arm group label: Collaborative Dementia Care Program
intervention type: Other
intervention name: Screening Only
description: The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening
arm group label: Screening Only
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole Fowler, PHD
role: Principal Investigator
affiliation: Indiana University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Nicole R. Fowler, PhD
investigator title: Scientist, Indiana University Center for Aging Research
mesh term: Alzheimer Disease
sharing ipd: No