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: Not yet recruiting
• Conditions: Cognitive Decline; Cognitive Impairment, Mild
• Intervention / Treatment: Behavioral: Walking conversational reminiscence

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 Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrice Fuller, BS; Phone Number: 503-505-4670; Email: fullerp@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 110 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of California, Davis; National Center for Advancing Translational Sciences (NCATS); Rush University; 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 (ANTICIPATED): May 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

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): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

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: 00022363; 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