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

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Cognitive Decline; Cognitive Impairment, Mild

Treatments: Behavioral: Walking conversational reminiscence

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04863378

STUDY00022363

KL2TR002370 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Cognitively healthy and mildly cognitively impaired participants engage in up to 8 weeks of baseline data collection and 4-16 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.

Enrollment: 13 patients

Sex: All

Ages: 65 to 110 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for walkers:

1. Self-identified African American,

2. Age > 65 years old

3. Reside or resided for >10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area),

4. Able to ambulate independently.

5. Meeting Cognition Criteria

   1. Participants with MCI (Mild Cognitive Impairment) will meet criteria consistent with the criteria outlined by the NIA-Alzheimer's Association workgroup
   2. 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.

6. Cognitive function allows independent (or minimally assisted) travel to and from walk locations

7. In-home reliable broadband internet (for weekly online surveys).

8. Ability to read, speak, and understand English

Exclusion Criteria:

1. Self-reported or clinically diagnosed dementia
2. Significant disease of the central nervous system
3. Severely depressed (CES-D score > 16), significantly symptomatic psychiatric disorder
4. Advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure
5. Unstable insulin-dependent diabetes mellitus, received diagnosis Type 1 Diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

Cognitive healthy participants

Experimental group

Description:

Participants are Black/African American adults aged 65 or over who are cognitively healthy according to a baseline Montreal Cognitive Assessment score of 24 or higher. Participants continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data is collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continue to wear the actigraph watch and continued to sleep on the sleep sensor, and walk 4-16 weeks with their triads. Triads walk 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) are accessed via the SHARP Walking Application via a group Android tablet device.

Treatment:

Behavioral: Walking conversational reminiscence

Community stakeholder interviewees

No Intervention group

Description:

Participants are Black/African American adults aged 55 and over who are individually interviewed to provide qualitative insight into salient historical landmarks and events to include in future walking routes for the Oakland area; Participants in this non-interventional group do not participate in study activities other than a qualitative interview.

Mildly Cognitively Impaired (MCI) participants

Experimental group

Description:

Participants are Black/African American adults aged 65 or over who are mildly cognitively impaired according to a baseline Montreal Cognitive Assessment score below 24. Participants continuously wear an actigraph watch to assess activity level. Daily sleep behavior is captured on an under-the-mattress sleep sensor. Up to 8 weeks of baseline data is collected on participants prior to starting the walking component of the intervention. After the baseline data collection period, participants continue to wear the actigraph watch and continued to sleep on the sleep sensor, and walk 4-16 weeks with their triads. Triads walk 1-mile routes, three times a week while engaging in image-prompted conversational reminiscence recorded for a digital archive. Walking routes and GPS-linked reminiscence prompts (historical images with questions) are accessed via the SHARP Walking Application via a group Android tablet device.

Treatment:

Behavioral: Walking conversational reminiscence