xml: <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/NCT05999929</url>
    </required_header>
    <id_info>
      <org_study_id>M16-23-024</org_study_id>
      <nct_id>NCT05999929</nct_id>
    </id_info>
    <brief_title>Memory Support System Feasibility Study</brief_title>
    <official_title>Implementation of the Memory Support System: A Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bruyere Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ottawa Hospital Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Bruyere Research Institute</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 study is to determining the feasibility of providing the Memory Support&#xD;
        System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a&#xD;
        clinic in Ontario, Canada. This will involve a) collecting information from patients referred&#xD;
        to the a memory clinic and geriatric day hospital about their interest in and their preferred&#xD;
        method to administer the MSS; and b) a cost analysis related to implementation of the MSS.&#xD;
        The study will also measure efficacy outcomes of the MSS regarding program adherence as well&#xD;
        as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and&#xD;
        caregiver burden among a sample of individuals with MCI and their care partners&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A survey will be created and sent out to participants with MCI who have expressed interest in&#xD;
        participating in research and have been seen at a memory clinic or geriatric day hospital&#xD;
        after the initiation of the study. The survey will consist of a Likert scale and open&#xD;
        questions related to patient interest in and preferred length of MSS administration and&#xD;
        preference for in-person versus virtual administration.&#xD;
  &#xD;
        During and after collection of the survey data, a sample of 20 individuals with MCI (ages&#xD;
        ≥50) and their care partners will undergo MSS training.&#xD;
  &#xD;
        At enrollment in the MSS training, participants with MCI and their care partners will&#xD;
        complete measures of cognitive and functional status. Participants and partners will also&#xD;
        complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life,&#xD;
        mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up.&#xD;
        Participants will complete the MSS training consisting of ten 1-hour sessions delivered over&#xD;
        two or six weeks, starting 7-10 days after initial assessment. Training will be offered in&#xD;
        English or French. After the intervention, participants and their partners will complete a&#xD;
        semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum,&#xD;
        and intervention logistics.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Interest in completion of MSS training</measure>
      <time_frame>From study start date up to 19 months.</time_frame>
      <description>Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adherence to French Memory Support System Intervention</measure>
      <time_frame>One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from adherence scores from one week after starting treatment (MSS intervention) at treatment end and at 8 weeks after the treatment end. Using an adherence scale from 0 to 10, with 10 being highest and a cut-off score of ≥ 7 points suggesting adherence with the MSS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Center for Epidemiologic Studies Depression Scale</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Depression screening scale using Likert scale. Total score of 0-60 points, with higher scores signifying a worse outcome (higher levels of depression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Everyday Cognition questionnaire.</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report measure of performance based instrumental activities of daily living. Total score of 23-92, with higher scores indicating a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Assessment Questionnaire</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based report of performance of instrumental activities of daily living. Total score of 0-30, with higher scores indicating a worse outcome (higher level of dependence).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life in Alzheimer Disease</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report quality of life scale. Total score of 13-52, with higher scores indicating a better outcome (better quality of life).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report anxiety scale. Total score of 10-40 with higher scores indicating a worse outcome (higher level of anxiety).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chronic Disease Self-efficacy Scale</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Selected questions related to memory and cognition from self report scale. Total score of 9-90 with higher scores indicating a better outcomes (higher feeling of self-efficacy).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver Burden Inventory Short-Form</measure>
      <time_frame>Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.</time_frame>
      <description>Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based scale of level of caregiver burden. Total score of 0-48 with higher scores indicating a worse outcome (higher level of burden).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Memory Support System participants</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Memory Support System</intervention_name>
      <description>The MSS is a two-page-per-day, pocket-sized calendar/note-taking system with three sections: (a) events; (b) to do's; and (c) journaling for logging important things to be remembered (e.g., news about family/friends). MSS training consists of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after baseline assessment.</description>
      <arm_group_label>Memory Support System participants</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of single or multi-domain MCI&#xD;
  &#xD;
            -  Clinical Dementia Rating global (CDR) score of ≤ 0.5&#xD;
  &#xD;
            -  Montreal Cognitive Assessment score of ≥18&#xD;
  &#xD;
            -  available contact with a care partner ≥ 2 times weekly&#xD;
  &#xD;
            -  absence or stable intake of nootropic(s) for ≥ 3 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  visual/hearing impairment and/or history of reading or written inability/disability&#xD;
               sufficient to interfere with MSS training&#xD;
  &#xD;
            -  concurrent participation in another related clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Neil Thomas, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bruyere Research Institute</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Octavio Santos, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ottawa Hospital Research Institute, Bruyere Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Neil Thomas, MD</last_name>
      <phone>613-562-6262</phone>
      <phone_ext>4071</phone_ext>
      <email>nthomas@bruyere.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Johanna Fievre</last_name>
      <phone>613-562-6262</phone>
      <phone_ext>1290</phone_ext>
      <email>JFievre@bruyere.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Bruyere Research Institute</name>
        <address>
          <city>Ottawa</city>
          <state>Ontario</state>
          <zip>K1H 5C8</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Johanna Fievre</last_name>
        <phone>613-562-6262</phone>
        <phone_ext>1290</phone_ext>
        <email>nthomas@bruyere.org</email>
      </contact>
      <contact_backup>
        <last_name>Neil Thomas, MD</last_name>
        <phone>613-562-6262</phone>
        <phone_ext>4071</phone_ext>
        <email>JFievre@bruyere.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cognition</keyword>
    <keyword>Intervention</keyword>
    <keyword>French</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data from the study may be shared with other researchers within the HABIT consortium. Data that may be shared will include the results of the feasibility survey and the scores from the baseline, treatment end and 8 week follow up outcome measures collected from participants who complete MSS training.</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data will be available after the end date of the study and kept indefinitely.</ipd_time_frame>
      <ipd_access_criteria>Upon request that is approved by the study principal investigators.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999929
  org study id: M16-23-024
  nct id: NCT05999929
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determining the feasibility of providing the Memory Support
        System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a
        clinic in Ontario, Canada. This will involve a) collecting information from patients referred
        to the a memory clinic and geriatric day hospital about their interest in and their preferred
        method to administer the MSS; and b) a cost analysis related to implementation of the MSS.
        The study will also measure efficacy outcomes of the MSS regarding program adherence as well
        as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and
        caregiver burden among a sample of individuals with MCI and their care partners
  A survey will be created and sent out to participants with MCI who have expressed interest in
        participating in research and have been seen at a memory clinic or geriatric day hospital
        after the initiation of the study. The survey will consist of a Likert scale and open
        questions related to patient interest in and preferred length of MSS administration and
        preference for in-person versus virtual administration.
  
        During and after collection of the survey data, a sample of 20 individuals with MCI (ages
        ≥50) and their care partners will undergo MSS training.
  
        At enrollment in the MSS training, participants with MCI and their care partners will
        complete measures of cognitive and functional status. Participants and partners will also
        complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life,
        mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up.
        Participants will complete the MSS training consisting of ten 1-hour sessions delivered over
        two or six weeks, starting 7-10 days after initial assessment. Training will be offered in
        English or French. After the intervention, participants and their partners will complete a
        semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum,
        and intervention logistics.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Interest in completion of MSS training
  time frame: From study start date up to 19 months.
  description: Percentage of participants that complete the feasibility survey and agree or strongly agree with the statement that they are interested in completing MSS training.
  measure: Adherence to French Memory Support System Intervention
  time frame: One week after starting the treatment (MSS intervention), at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from adherence scores from one week after starting treatment (MSS intervention) at treatment end and at 8 weeks after the treatment end. Using an adherence scale from 0 to 10, with 10 being highest and a cut-off score of ≥ 7 points suggesting adherence with the MSS.
  measure: Center for Epidemiologic Studies Depression Scale
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Depression screening scale using Likert scale. Total score of 0-60 points, with higher scores signifying a worse outcome (higher levels of depression).
  measure: Everyday Cognition questionnaire.
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report measure of performance based instrumental activities of daily living. Total score of 23-92, with higher scores indicating a worse outcome.
  measure: Functional Assessment Questionnaire
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based report of performance of instrumental activities of daily living. Total score of 0-30, with higher scores indicating a worse outcome (higher level of dependence).
  measure: Quality of Life in Alzheimer Disease
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report quality of life scale. Total score of 13-52, with higher scores indicating a better outcome (better quality of life).
  measure: State-Trait Anxiety Inventory by the Resources for Enhancing Alzheimer's Caregiver Health project
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Self report anxiety scale. Total score of 10-40 with higher scores indicating a worse outcome (higher level of anxiety).
  measure: Chronic Disease Self-efficacy Scale
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Selected questions related to memory and cognition from self report scale. Total score of 9-90 with higher scores indicating a better outcomes (higher feeling of self-efficacy).
  measure: Caregiver Burden Inventory Short-Form
  time frame: Baseline, at completion of the treatment - on average 6 weeks, and at 8 week follow-up after treatment end.
  description: Change from baseline scale scores at treatment end and at 8 weeks after treatment end. Informant based scale of level of caregiver burden. Total score of 0-48 with higher scores indicating a worse outcome (higher level of burden).
  arm group label: Memory Support System participants
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Memory Support System
  description: The MSS is a two-page-per-day, pocket-sized calendar/note-taking system with three sections: (a) events; (b) to do's; and (c) journaling for logging important things to be remembered (e.g., news about family/friends). MSS training consists of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after baseline assessment.
  arm group label: Memory Support System participants
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Neil Thomas, MD
  role: Principal Investigator
  affiliation: Bruyere Research Institute
  last name: Octavio Santos, PhD
  role: Principal Investigator
  affiliation: Ottawa Hospital Research Institute, Bruyere Research Institute
  last name: Neil Thomas, MD
  phone: 613-562-6262
  phone ext: 4071
  email: nthomas@bruyere.org
  last name: Johanna Fievre
  phone: 613-562-6262
  phone ext: 1290
  email: JFievre@bruyere.org
  facility: 
  contact: 
  contact backup: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: De-identified data from the study may be shared with other researchers within the HABIT consortium. Data that may be shared will include the results of the feasibility survey and the scores from the baseline, treatment end and 8 week follow up outcome measures collected from participants who complete MSS training.
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data will be available after the end date of the study and kept indefinitely.
  ipd access criteria: Upon request that is approved by the study principal investigators.