Efficacy of a Multimodal Brain Health Intervention for Older African Americans

NCT ID: NCT04863378

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-10-01

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.

Detailed 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.

Conditions

Cognitive Impairment, Mild; Cognitive Decline

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cognitive healthy participants

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.

Group Type: EXPERIMENTAL

Walking conversational reminiscence

Intervention Type: BEHAVIORAL

Triadic walking with prompted conversational reminiscence

Community stakeholder interviewees

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mildly Cognitively Impaired (MCI) participants

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.

Group Type: EXPERIMENTAL

Walking conversational reminiscence

Intervention Type: BEHAVIORAL

Triadic walking with prompted conversational reminiscence

Interventions

Walking conversational reminiscence

Triadic walking with prompted conversational reminiscence

Intervention Type: BEHAVIORAL

Other Intervention Names

SHARP: Sharing History through Active Reminiscence and Photo-imagery

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Oregon Clinical and Translational Research Institute

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Raina Croff

Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raina Croff, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

Croff RL, Witter Iv P, Walker ML, Francois E, Quinn C, Riley TC, Sharma NF, Kaye JA. Things Are Changing so Fast: Integrative Technology for Preserving Cognitive Health and Community History. Gerontologist. 2019 Jan 9;59(1):147-157. doi: 10.1093/geront/gny069.

Reference Type: BACKGROUND

PMID: 29961887 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

KL2TR002370

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00022363

Identifier Type: -

Identifier Source: org_study_id