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The Brain Health Champion Study (BHC)

Primary Purpose

Mild Cognitive Impairment, Dementia, Mild, Subjective Cognitive Decline

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Health Champion
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring mild cognitive impairment, dementia risk reduction, brain health

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • 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.

Sites / Locations

  • Brigham and Women's Hospital, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Brain Health Champion (BHC)

Standard of Care (SOC)

Arm Description

A "health coach" intervention with weekly phone calls

The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice

Outcomes

Primary Outcome Measures

Self-report adherence to Mediterranean diet
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.
Self-report participation in cognitive and socially stimulating activities
Florida Cognitive Activities Scale (questionnaire). Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.
Self-report exercise and physical activity
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

Quality of Life Self-Report
Flanagan Quality of Life Scale (questionnaire). Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
Neuropsychiatric status
Neuropsychiatric Inventory Questionnaire. Measures caregiver report of 12 neuropsychiatric symptoms, severity (1-3) and distress (0-5) with higher values indicating more neuropsychiatric symptoms.
Cognitive function
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.
Sleep
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.

Full Information

First Posted
November 25, 2018
Last Updated
March 8, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03772977
Brief Title
The Brain Health Champion Study
Acronym
BHC
Official Title
The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
July 23, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Dementia, Mild, Subjective Cognitive Decline, At Risk for Cognitive Decline
Keywords
mild cognitive impairment, dementia risk reduction, brain health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brain Health Champion (BHC)
Arm Type
Experimental
Arm Description
A "health coach" intervention with weekly phone calls
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm 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(s)
Brain Health Champion
Intervention Description
A health coach embedded within an existing clinical care team
Primary Outcome Measure Information:
Title
Self-report adherence to Mediterranean diet
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.
Time Frame
6 months
Title
Self-report participation in cognitive and socially stimulating activities
Description
Florida Cognitive Activities Scale (questionnaire). Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.
Time Frame
6 months
Title
Self-report exercise and physical activity
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life Self-Report
Description
Flanagan Quality of Life Scale (questionnaire). Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
Time Frame
6 months
Title
Neuropsychiatric status
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.
Time Frame
6 months
Title
Cognitive function
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.
Time Frame
6 months
Title
Sleep
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth A Gale, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital, Department of Neurology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31763431
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.
Results Reference
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The Brain Health Champion Study

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