Efficacy of a Multimodal Brain Health Intervention for Older African Americans

Study Overview
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Brief Summary
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This study tests the feasibility, acceptability, and efficacy of a multimodal intervention (walking, social engagement, and reminiscence), including the use of wearable digital biomarkers, for cognitively healthy and mildly cognitively impaired African Americans aged 65 and older.

Detailed Description
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Cognitively healthy and mildly cognitively impaired participants engage in 16 weeks of triadic neighborhood walking using a group tablet device to access pre-programmed 1-mile routes. GPS (Global Positioning System)-triggered historical images of local Black culture and history along the route prompt conversational reminiscence about Portland, Oregon's historically Black neighborhoods. Digital biomarker technology (a continuously worn actigraph watch and an unobtrusive under-the-mattress sleep sensor) and weekly online surveys via a study Chromebook assess feasibility, acceptability, efficacy, and health outcomes. Intermittent discussions and check-ins with participants, and observational sessions will be used to elicit participant feedback.

Official Title
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Efficacy of a Technology-Based Multimodal Brain Health Intervention for Older African Americans: The SHARP Study

Conditions
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Cognitive Impairment, Mild, Cognitive Decline

Intervention / Treatment
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* Behavioral: Walking conversational reminiscence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified African American, Age > 65 years old Reside or resided for >10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area), Able to ambulate independently. Meeting Cognition Criteria Participants with MCI (Mild Cognitive Impairment) will meet criteria consistent with the criteria outlined by the NIA-Alzheimer's Association workgroup Participants without cognitive impairment will have a Montreal Cognitive Assessment (MoCA) score > 24 (and not meet MCI criteria). Participants' cognitive function should allow them to get to and from walk locations independently or with minimal assistance. Cognitive function allows independent (or minimally assisted) travel to and from walk locations In-home reliable broadband internet (for weekly online surveys). Ability to read, speak, and understand English Exclusion Criteria: Self-reported or clinically diagnosed dementia Significant disease of the central nervous system Severely depressed (CES-D score > 16), significantly symptomatic psychiatric disorder Advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure Unstable insulin-dependent diabetes mellitus, received diagnosis Type 1 Diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walkers<br>Walkers continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Participants walk 1-mile routes in triads, three times a week for 16 weeks while engaging in prompted conversational reminiscence recorded for a digital archive. | Behavioral: Walking conversational reminiscence<br>* Triadic walking with prompted conversational reminiscence<br>* Other names: SHARP: Sharing History through Active Reminiscence and Photo-imagery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in daily activity time recorded by actigraphy watch | A continuously worn actigraphy watch (Withings) measures 24-hour activity (gross motor activity). | 16 weeks | 
| Change from baseline in sleep time recorded by actigraphy watch and Emfit QS sleep sensor | Actigraphy watch and Emfit QS under-the-mattress sleep sensor measure sleep-wake cycles per 24-hour period. | 16 weeks | 
| Change from baseline in sleep movement recorded by Emfit QS sleep sensor | An Emfit QS sleep sensor measures movement activity in bed. | 16 weeks | 
| Change from baseline in weight recorded by digital scale and by Emfit QS sleep sensor | A digital scale and Emfit QS sleep sensor measure weight. | 16 weeks | 
| Change from baseline in global cognition | Global cognitive function measured by the Montreal Cognitive Assessment total score (MoCA total score). Montreal Cognitive Assessment is a neuropsychological test. Total score ranges from 0 to 30. Higher scores indicate better cognitive function. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social engagement, neighborhood walking, reminiscence, physical activity, African American, Mild cognitive impairment