Efficacy of a Multimodal Brain Health Intervention for Older African Americans

Cognitive Decline Clinical Trial

— SHARP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04863378
• Other study ID #: 00022363
• Secondary ID: KL2TR002370
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: June 2022

Study information

• Verified date: April 2021
• Source: Oregon Health and Science University
• Contact: Patrice Fuller, BS
• Phone: 503-505-4670
• Email: fullerp[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 110 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Behavioral:
• Walking conversational reminiscence
Triadic walking with prompted conversational reminiscence

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Advancing Translational Science (NCATS), Oregon Clinical and Translational Research Institute, Rush University, University of California, Davis

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from baseline in sleep movement recorded by Emfit QS sleep sensor	An Emfit QS sleep sensor measures movement activity in bed.	16 weeks
Primary	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
Primary	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