The Brain Health Champion Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-08

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brain Health Together: Development and Pilot Test

NCT06914947

Cognitive Impairment Subjective Cognitive Decline Mild Cognitive Impairment (MCI)

COMPLETED

Brain Health Fitness Program: Exercise for People with Mild-moderate Cognitive Impairments

NCT06799429

Cognitive Impairment

RECRUITING NA

Mindfulness for Cognition in Early-stage Alzheimer's Disease

NCT06792877

Mild Cognitive Impairment (MCI) Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease TBI (Traumatic Brain Injury) +3 more

RECRUITING NA

Cognitive Training to Promote Brain Health: Implementation and Engagement

NCT03408509

Aging Mild Cognitive Impairment

UNKNOWN PHASE2

Compensatory Training to Support Brain Healthy Lifestyle Changes in Those at Risk for Alzheimer's Disease

NCT04118985

Cognitive Symptom Pre Senile Dementia Alzheimer Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brain Health Champion (BHC)

A "health coach" intervention with weekly phone calls

Group Type EXPERIMENTAL

Brain Health Champion

Intervention Type BEHAVIORAL

A health coach embedded within an existing clinical care team

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brain Health Champion

A health coach embedded within an existing clinical care team

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes