<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/NCT03772977</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000384</org_study_id>
    <nct_id>NCT03772977</nct_id>
  </id_info>
  <brief_title>The Brain Health Champion Study</brief_title>
  <acronym>BHC</acronym>
  <official_title>The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</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>
      6-month, randomized, controlled investigation measuring the effect of increased clinical&#xD;
      contact and personalization compared to standard physician counseling on adherence to&#xD;
      consensus-based, brain health recommendations for patients with subjective cognitive decline,&#xD;
      mild cognitive impairment, and early dementia or patients who are at risk for developing&#xD;
      these conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 6-month, randomized, controlled investigation measuring the effect of increased&#xD;
      clinical contact and personalized recommendations from a health coach, compared to standard&#xD;
      physician counseling on adherence to consensus-based, brain health recommendations, including&#xD;
      80 patients with either subjective cognitive decline, MCI, or early dementia enrolled from a&#xD;
      hospital-based memory disorders clinic, or, with risk factors for dementia enrolled from a&#xD;
      hospital-based primary care clinic. Participants and caregivers in the health coach arm work&#xD;
      with a health coach within their respective practice, called the a &quot;brain health champion&quot;&#xD;
      (BHC), through weekly motivational phone calls every 6 weeks. In the encounters and visits,&#xD;
      BHCs and patients/caregivers work together to establish, update, and achieve personalized,&#xD;
      attainable lifestyle goals. Participants in the control arm receive standard counseling and&#xD;
      education from providers during routine clinic visits. Changes in physical activity, dietary&#xD;
      pattern, and social and cognitive activities are measured using questionnaires validated in&#xD;
      cognitively impaired and normal populations. Other outcomes include measures of quality of&#xD;
      life (QOL), cognitive function, neuropsychiatric status, sleep quality, and behavior.&#xD;
      Follow-up assessments are also completed at 6 months post-intervention, with some patients&#xD;
      receiving &quot;booster&quot; encounters to assess the maintenance of behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 23, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-report adherence to Mediterranean diet</measure>
    <time_frame>6 months</time_frame>
    <description>Goulet Mediterranean Diet Score (questionnaire).&#xD;
Measured adherence to the Mediterranean Diet. Likert Scale 0-44, with higher values indicating stronger adherence to the dietary pattern.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-report participation in cognitive and socially stimulating activities</measure>
    <time_frame>6 months</time_frame>
    <description>Florida Cognitive Activities Scale (questionnaire).&#xD;
Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-report exercise and physical activity</measure>
    <time_frame>6 months</time_frame>
    <description>Physical Activity Scale for the Elderly (questionnaire).&#xD;
Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Self-Report</measure>
    <time_frame>6 months</time_frame>
    <description>Flanagan Quality of Life Scale (questionnaire).&#xD;
Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric status</measure>
    <time_frame>6 months</time_frame>
    <description>Neuropsychiatric Inventory Questionnaire.&#xD;
Measures caregiver report of 12 neuropsychiatric symptoms, severity (1-3) and distress (0-5) with higher values indicating more neuropsychiatric symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>6 months</time_frame>
    <description>Mini Mental Status Examination: Multidomain cognitive test, scored 0-30.&#xD;
PACC-BHC: Neurosychological test battery including: 1) Free and Cued Selective Reminding Test (FCSRT); 2) Logical Memory, immediate and delayed Story Recall; 3) Visual Paired Associates; 4) Digit-Symbol Substitution Test; 5) Trail Making Test, Part A; 6) Trail Making, Part B; 7) Number Span, 8) Category Fluency (animals, fruits, vegetables); and 9) Phonemic Fluency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep</measure>
    <time_frame>6 months</time_frame>
    <description>Medical Outcomes Study Sleep Scale&#xD;
Likert scale measuring sleep quality and sleep problems index. 0-60 with greater values representing higher sleep quality and lower sleep problems.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Dementia, Mild</condition>
  <condition>Subjective Cognitive Decline</condition>
  <condition>At Risk for Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Brain Health Champion (BHC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A &quot;health coach&quot; intervention with weekly phone calls</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brain Health Champion</intervention_name>
    <description>A health coach embedded within an existing clinical care team</description>
    <arm_group_label>Brain Health Champion (BHC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Be age 55 to 85&#xD;
&#xD;
          -  Existing patient at Brigham Health system with at least one prior visit with providers&#xD;
             and plans to establish/continue longitudinal care&#xD;
&#xD;
          -  Be sufficiently fluent in the English language to understand instructions and perform&#xD;
             the cognitive and functional tests&#xD;
&#xD;
          -  For neurology participants only: Have a diagnosis of Subjective Cognitive Disorder&#xD;
             (SCD) (MMSE guideline 27-30), Mild Cognitive Impairment (MCI) due to Alzheimer disease&#xD;
             (AD), cerebrovascular disease (CVD), or mixed-type AD/CVD (MMSE guideline 24-30), or&#xD;
             mild dementia due to AD, CVD, or mixed-AD/CVD (MMSE guideline 20-30). In some cases,&#xD;
             based on the clinical judgment of the treating neurologist, we may enroll a patient&#xD;
             who falls outside of these guidelines or whose diagnosis and overall level of&#xD;
             functioning does not perfectly correlate to their MMSE score.&#xD;
&#xD;
          -  For primary care participants only: Cardiovascular Risk Factors, Aging, and Incidence&#xD;
             of Dementia (CAIDE) dementia risk score of ≥ 6, or score of 5 plus one of the&#xD;
             following: a history of ADRD in a first-degree relative, or type II diabetes or&#xD;
             &quot;pre-diabetes&quot; spectrum (A1C level ≥ 5.7)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Be enrolled in another health behavior or non-pharmacologic intervention for a&#xD;
             neurocognitive disorder&#xD;
&#xD;
          -  Be unable to or unwilling to carry out regular physical exercise, multiple times&#xD;
             weekly.&#xD;
&#xD;
          -  Be not recommended to participate by their Internist/Primary Care Provider due to&#xD;
             health-related concerns.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seth A Gale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brigham and Women's Hospital, Department of Neurology</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Schwartz HEM, Bay CP, McFeeley BM, Krivanek TJ, Daffner KR, Gale SA. The Brain Health Champion study: Health coaching changes behaviors in patients with cognitive impairment. Alzheimers Dement (N Y). 2019 Nov 12;5:771-779. doi: 10.1016/j.trci.2019.09.008. eCollection 2019.</citation>
    <PMID>31763431</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>March 8, 2022</last_update_submitted>
  <last_update_submitted_qc>March 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Seth Gale</investigator_full_name>
    <investigator_title>Associate Neurologist, Assistant Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>mild cognitive impairment</keyword>
  <keyword>dementia risk reduction</keyword>
  <keyword>brain health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>June 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT03772977/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03772977
org study id: 2017P000384
nct id: NCT03772977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
6-month, randomized, controlled investigation measuring the effect of increased clinical
      contact and personalization compared to standard physician counseling on adherence to
      consensus-based, brain health recommendations for patients with subjective cognitive decline,
      mild cognitive impairment, and early dementia or patients who are at risk for developing
      these conditions.
This is a 6-month, randomized, controlled investigation measuring the effect of increased
      clinical contact and personalized recommendations from a health coach, compared to standard
      physician counseling on adherence to consensus-based, brain health recommendations, including
      80 patients with either subjective cognitive decline, MCI, or early dementia enrolled from a
      hospital-based memory disorders clinic, or, with risk factors for dementia enrolled from a
      hospital-based primary care clinic. Participants and caregivers in the health coach arm work
      with a health coach within their respective practice, called the a "brain health champion"
      (BHC), through weekly motivational phone calls every 6 weeks. In the encounters and visits,
      BHCs and patients/caregivers work together to establish, update, and achieve personalized,
      attainable lifestyle goals. Participants in the control arm receive standard counseling and
      education from providers during routine clinic visits. Changes in physical activity, dietary
      pattern, and social and cognitive activities are measured using questionnaires validated in
      cognitively impaired and normal populations. Other outcomes include measures of quality of
      life (QOL), cognitive function, neuropsychiatric status, sleep quality, and behavior.
      Follow-up assessments are also completed at 6 months post-intervention, with some patients
      receiving "booster" encounters to assess the maintenance of behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Self-report adherence to Mediterranean diet
time frame: 6 months
description: Goulet Mediterranean Diet Score (questionnaire).
Measured adherence to the Mediterranean Diet. Likert Scale 0-44, with higher values indicating stronger adherence to the dietary pattern.
measure: Self-report participation in cognitive and socially stimulating activities
time frame: 6 months
description: Florida Cognitive Activities Scale (questionnaire).
Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.
measure: Self-report exercise and physical activity
time frame: 6 months
description: Physical Activity Scale for the Elderly (questionnaire).
Measures walking, moderate, and vigorous activity. Zero lower limit, no upper limit. Higher values indicate more physical activity.
measure: Quality of Life Self-Report
time frame: 6 months
description: Flanagan Quality of Life Scale (questionnaire).
Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
measure: Neuropsychiatric status
time frame: 6 months
description: Neuropsychiatric Inventory Questionnaire.
Measures caregiver report of 12 neuropsychiatric symptoms, severity (1-3) and distress (0-5) with higher values indicating more neuropsychiatric symptoms.
measure: Cognitive function
time frame: 6 months
description: Mini Mental Status Examination: Multidomain cognitive test, scored 0-30.
PACC-BHC: Neurosychological test battery including: 1) Free and Cued Selective Reminding Test (FCSRT); 2) Logical Memory, immediate and delayed Story Recall; 3) Visual Paired Associates; 4) Digit-Symbol Substitution Test; 5) Trail Making Test, Part A; 6) Trail Making, Part B; 7) Number Span, 8) Category Fluency (animals, fruits, vegetables); and 9) Phonemic Fluency.
measure: Sleep
time frame: 6 months
description: Medical Outcomes Study Sleep Scale
Likert scale measuring sleep quality and sleep problems index. 0-60 with greater values representing higher sleep quality and lower sleep problems.
arm group label: Brain Health Champion (BHC)
arm group type: Experimental
description: A "health coach" intervention with weekly phone calls
arm group label: Standard of Care (SOC)
arm group type: No Intervention
description: The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice
intervention type: Behavioral
intervention name: Brain Health Champion
description: A health coach embedded within an existing clinical care team
arm group label: Brain Health Champion (BHC)
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Seth A Gale, MD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
facility: 
country: United States
citation: Schwartz HEM, Bay CP, McFeeley BM, Krivanek TJ, Daffner KR, Gale SA. The Brain Health Champion study: Health coaching changes behaviors in patients with cognitive impairment. Alzheimers Dement (N Y). 2019 Nov 12;5:771-779. doi: 10.1016/j.trci.2019.09.008. eCollection 2019.
PMID: 31763431
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Seth Gale
investigator title: Associate Neurologist, Assistant Professor of Neurology
mesh term: Dementia
mesh term: Cognitive Dysfunction
sharing ipd: No
provided document: 