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The Brain Health Champion Study (BHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772977
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Seth Gale, Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dementia, Mild Subjective Cognitive Decline At Risk for Cognitive Decline Behavioral: Brain Health Champion Phase 1

Detailed Description:
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 and in-person visits 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : October 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Brain Health Champion (BHC)
A "health coach" intervention with weekly phone calls and in-person visits
Behavioral: Brain Health Champion
A health coach embedded within an existing clinical care team

No Intervention: Standard of Care (SOC)
The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice



Primary Outcome Measures :
  1. Self-report adherence to Mediterranean diet [ Time Frame: 6 months ]

    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.


  2. Self-report participation in cognitive and socially stimulating activities [ Time Frame: 6 months ]

    Florida Cognitive Activities Scale (questionnaire).

    Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.


  3. Self-report exercise and physical activity [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures :
  1. Quality of Life Self-Report [ Time Frame: 6 months ]

    Flanagan Quality of Life Scale (questionnaire).

    Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.


  2. Neuropsychiatric status [ Time Frame: 6 months ]

    Neuropsychiatric Inventory Questionnaire.

    Measures caregiver report of 12 neuropsychiatric symptoms, severity (1-3) and distress (0-5) with higher values indicating more neuropsychiatric symptoms.


  3. Cognitive function [ Time Frame: 6 months ]

    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.


  4. Sleep [ Time Frame: 6 months ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Be age 55 to 85
  • Existing patient at Brigham Health system with at least one prior visit with providers and plans to establish/continue longitudinal care
  • Be sufficiently fluent in the English language to understand instructions and perform the cognitive and functional tests
  • Be able to travel to Brigham Health for monthly follow up visits with the BHC study team.
  • For neurology participants only: Have a diagnosis of Subjective Cognitive Disorder (SCD) (MMSE guideline 27-30), Mild Cognitive Impairment (MCI) due to Alzheimer disease (AD), cerebrovascular disease (CVD), or mixed-type AD/CVD (MMSE guideline 24-30), or mild dementia due to AD, CVD, or mixed-AD/CVD (MMSE guideline 20-30). In some cases, based on the clinical judgment of the treating neurologist, we may enroll a patient who falls outside of these guidelines or whose diagnosis and overall level of functioning does not perfectly correlate to their MMSE score.
  • For primary care participants only: Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score of ≥ 6, or score of 5 plus one of the following: a history of ADRD in a first-degree relative, or type II diabetes or "pre-diabetes" spectrum (A1C level ≥ 5.7)

Exclusion criteria:

  • Be enrolled in another health behavior or non-pharmacologic intervention for a neurocognitive disorder
  • Be unable to or unwilling to carry out regular physical exercise, multiple times weekly.
  • Be not recommended to participate by their Internist/Primary Care Provider due to health-related concerns.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772977


Locations
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United States, Massachusetts
Brigham and Women's Hospital, Department of Neurology
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Seth A Gale, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Seth Gale, Brigham and Women's Hospital:
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Responsible Party: Seth Gale, Associate Neurologist, Instructor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03772977    
Other Study ID Numbers: 2017P000384
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seth Gale, Brigham and Women's Hospital:
mild cognitive impairment
dementia risk reduction
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders