The Brain Health Champion Study

N/AActive Not RecruitingNCT03772977

Brigham and Women's Hospital95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mild Cognitive Impairment Dementia, Mild Subjective Cognitive Decline At Risk for Cognitive Decline

Interventions

Brain Health ChampionBEHAVIORAL

A health coach embedded within an existing clinical care team

Eligibility

Sex: ALLMin age: 60 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * Be age 60 to 79 * 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.

Locations (1)

Brigham and Women's Hospital, Department of Neurology

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

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.

Time frame: 6 months

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

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.

Time frame: 6 months

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.

Data from ClinicalTrials.gov

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