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The Brain Health Champion Study (BHC)

Mass General Brigham logo

Mass General Brigham

Status

Active, not recruiting

Conditions

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

Treatments

Behavioral: Brain Health Champion

Study type

Interventional

Funder types

Other

Identifiers

NCT03772977
2017P000384

Details and patient eligibility

About

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.

Full 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.

Enrollment

95 estimated patients

Sex

All

Ages

60 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

95 participants in 2 patient groups

Brain Health Champion (BHC)
Experimental group
Description:
A "health coach" intervention with weekly phone calls
Treatment:
Behavioral: Brain Health Champion
Standard of Care (SOC)
No Intervention group
Description:
The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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