The Brain Health Champion Study

Mild Cognitive Impairment Clinical Trial

— BHC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03772977
• Other study ID #: 2017P000384
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 95
• Est. completion date: June 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Brain Health Champion
A health coach embedded within an existing clinical care team

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, Department of Neurology	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report adherence to Mediterranean diet	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.	6 months
Primary	Self-report participation in cognitive and socially stimulating activities	Florida Cognitive Activities Scale (questionnaire).; Measures participation in socially and cognitively stimulating activities. Likert Scale 0-180, with higher values indicating greater participation.	6 months
Primary	Self-report exercise and physical activity	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.	6 months
Secondary	Quality of Life Self-Report	Flanagan Quality of Life Scale (questionnaire).; Measures quality of life. Likert scale 0-112, higher values indicate higher quality of life.	6 months
Secondary	Neuropsychiatric status	Neuropsychiatric Inventory Questionnaire.; Measures caregiver report of 12 neuropsychiatric symptoms, severity (1-3) and distress (0-5) with higher values indicating more neuropsychiatric symptoms.	6 months
Secondary	Cognitive function	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.	6 months
Secondary	Sleep	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.	6 months

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