BHC: The Brain Health Champion Study

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03772977

Collaborator

(none)

Enrollment

Location

Arms

67.8

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Dementia, Mild Subjective Cognitive Decline At Risk for Cognitive Decline	Behavioral: Brain Health Champion	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

85 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 :

Jul 23, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain Health Champion (BHC) A "health coach" intervention with weekly phone calls	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

Arm

Intervention/Treatment

Experimental: Brain Health Champion (BHC)

A "health coach" intervention with weekly phone calls

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

Outcome Measures

Primary Outcome Measures

Self-report adherence to Mediterranean diet [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.
Self-report participation in cognitive and socially stimulating activities [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.
Self-report exercise and physical activity [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

Quality of Life Self-Report [6 months]
Flanagan Quality of Life Scale (questionnaire). Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.
Neuropsychiatric status [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.
Cognitive function [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.
Sleep [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.