SHARP: Efficacy of a Multimodal Brain Health Intervention for Older African Americans

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04863378

Collaborator

National Center for Advancing Translational Science (NCATS) (NIH), Oregon Clinical and Translational Research Institute (Other), University of California, Davis (Other), Rush University (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment, Mild Cognitive Decline	Behavioral: Walking conversational reminiscence	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Walkers 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 Triadic walking with prompted conversational reminiscence Other Names: SHARP: Sharing History through Active Reminiscence and Photo-imagery

Arm

Intervention/Treatment

Experimental: Walkers

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

Triadic walking with prompted conversational reminiscence

Other Names:

SHARP: Sharing History through Active Reminiscence and Photo-imagery

Outcome Measures

Primary Outcome Measures

Change from baseline in daily activity time recorded by actigraphy watch [16 weeks]
A continuously worn actigraphy watch (Withings) measures 24-hour activity (gross motor activity).
Change from baseline in sleep time recorded by actigraphy watch and Emfit QS sleep sensor [16 weeks]
Actigraphy watch and Emfit QS under-the-mattress sleep sensor measure sleep-wake cycles per 24-hour period.
Change from baseline in sleep movement recorded by Emfit QS sleep sensor [16 weeks]
An Emfit QS sleep sensor measures movement activity in bed.
Change from baseline in weight recorded by digital scale and by Emfit QS sleep sensor [16 weeks]
A digital scale and Emfit QS sleep sensor measure weight.
Change from baseline in global cognition [16 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.