The Brain Health Champion Study

Not Applicable

Active, not recruiting

• Conditions: Subjective Cognitive Decline; Mild Cognitive Impairment; Dementia, Mild; At Risk for Cognitive Decline
• Interventions: Behavioral: Brain Health Champion

• Registration Number: NCT03772977
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-08
• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-12
• Primary Completion: 2024-07-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain Health Champion (BHC)	Brain Health Champion	A "health coach" intervention with weekly phone calls

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Brigham and Women's Hospital, Department of Neurology; 🇺🇸 Boston, Massachusetts, United States