Clinical trial NCT03772977: The Brain Health Champion Study
Official title: The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia, Mild
Subjective Cognitive Decline
At Risk for Cognitive Decline
Keywords: mild cognitive impairment
dementia risk reduction
brain health
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 95
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-report adherence to Mediterranean diet
timeFrame: 6 months
measure: Self-report participation in cognitive and socially stimulating activities
timeFrame: 6 months
measure: Self-report exercise and physical activity
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life Self-Report
timeFrame: 6 months
measure: Neuropsychiatric status
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Sleep
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital, Department of Neurology
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Seth A Gale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz HEM, Bay CP, McFeeley BM, Krivanek TJ, Daffner KR, Gale SA. The Brain Health Champion study: Health coaching changes behaviors in patients with cognitive impairment. Alzheimers Dement (N Y). 2019 Nov 12;5:771-779. doi: 10.1016/j.trci.2019.09.008. eCollection 2019.