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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Decline; Cognitive Impairment, Mild
• Intervention / Treatment: Behavioral: Walking conversational reminiscence

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 110 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Walking conversational reminiscence; Triadic walking with prompted conversational reminiscence; Other Names: SHARP: Sharing History through Active Reminiscence and Photo-imagery
No Intervention: 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.
Experimental: 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.	Behavioral: Walking conversational reminiscence; Triadic walking with prompted conversational reminiscence; Other Names: SHARP: Sharing History through Active Reminiscence and Photo-imagery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Average Steps Recorded by Actigraphy Watch	Daily steps are recorded on a continuously worn actigraphy watch (Withings), which measures 24-hour activity (gross motor activity).	24 weeks
Daily Average Sleep Time Recorded by an Emfit QS Sleep Sensor	Emfit QS under-the-mattress sleep sensor measured sleep-wake cycles per 24-hour period.	24 weeks
Weekly Health Update Survey Response Time	Participants completed a brief health update survey every week via their home computer or phone. Response time (the time it took each participant to complete the survey) was recorded in seconds.	24 weeks
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire assessing sleep quality and sleep disturbances over a 1-month time period. The PQSI is composed of 19 query items, a combination of open-ended questions and Likert-type scales which are scored from 0 (no difficulty) to 3 (severe difficulty), and includes 7 sleep components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global score is calculated from the sum of scores for each of the seven components. Total scores range from 0 to 21, a higher score indicates more acute sleep disturbances.	24 weeks
Weekly Survey Completion Rate	Healthy and mildly cognitively impaired participants completed a weekly online health update survey, receiving weekly reminders to complete it. Survey completion rates and completion times over the study's duration is another measure of cognitive change.	24 Weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of California, Davis; National Center for Advancing Translational Sciences (NCATS); Oregon Clinical and Translational Research Institute
• Investigators: Principal Investigator: Raina Croff, PhD, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; African American; Mild cognitive impairment; reminiscence; social engagement; neighborhood walking
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: STUDY00022363; KL2TR002370 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No