NCT03772977

The Brain Health Champion Study

The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Brain Health Champion	A health coach embedded within an existing clinical care team

Timeline

• Start date: 2017-05-08
• Primary completion: 2024-07-01
• Completion: 2026-06-01
• First posted: 2018-12-12
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States