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

Primary Purpose

Cognitive Impairment, Mild, Cognitive Decline

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Walking conversational reminiscence

About this trial

This is an interventional prevention trial for Cognitive Impairment, Mild focused on measuring social engagement, neighborhood walking, reminiscence, physical activity, African American, Mild cognitive impairment

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Self-identified African American,
Age > 65 years old
Reside or resided for >10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area),
Able to ambulate independently.
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.
Cognitive function allows independent (or minimally assisted) travel to and from walk locations
In-home reliable broadband internet (for weekly online surveys).
Ability to read, speak, and understand English

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Walkers

Arm Description

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.

Outcomes

Primary Outcome Measures

Change from baseline in daily activity time recorded by actigraphy watch

A continuously worn actigraphy watch (Withings) measures 24-hour activity (gross motor activity).

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.

Change from baseline in sleep movement recorded by Emfit QS sleep sensor

An Emfit QS sleep sensor measures movement activity in bed.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04863378

First Posted

April 21, 2021

Last Updated

April 26, 2021

Sponsor

Oregon Health and Science University

Collaborators

National Center for Advancing Translational Sciences (NCATS), Oregon Clinical and Translational Research Institute, University of California, Davis, Rush University

1. Study Identification

Unique Protocol Identification Number

NCT04863378

Brief Title

Efficacy of a Multimodal Brain Health Intervention for Older African Americans

Acronym

SHARP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 2021 (Anticipated)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oregon Health and Science University

Collaborators

National Center for Advancing Translational Sciences (NCATS), Oregon Clinical and Translational Research Institute, University of California, Davis, Rush University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment, Mild, Cognitive Decline

Keywords

social engagement, neighborhood walking, reminiscence, physical activity, African American, Mild cognitive impairment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Walkers

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Walking conversational reminiscence

Other Intervention Name(s)

SHARP: Sharing History through Active Reminiscence and Photo-imagery

Intervention Description

Triadic walking with prompted conversational reminiscence

Primary Outcome Measure Information:

Title

Change from baseline in daily activity time recorded by actigraphy watch

Description

A continuously worn actigraphy watch (Withings) measures 24-hour activity (gross motor activity).

Time Frame

16 weeks

Title

Change from baseline in sleep time recorded by actigraphy watch and Emfit QS sleep sensor

Description

Actigraphy watch and Emfit QS under-the-mattress sleep sensor measure sleep-wake cycles per 24-hour period.

Time Frame

16 weeks

Title

Change from baseline in sleep movement recorded by Emfit QS sleep sensor

Description

An Emfit QS sleep sensor measures movement activity in bed.

Time Frame

16 weeks

Title

Change from baseline in weight recorded by digital scale and by Emfit QS sleep sensor

Description

A digital scale and Emfit QS sleep sensor measure weight.

Time Frame

16 weeks

Title

Change from baseline in global cognition

Description

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

110 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Self-identified African American, Age > 65 years old Reside or resided for >10 years in Portland's historically Black neighborhoods (to be familiar with Memory Markers about this area), Able to ambulate independently. Meeting Cognition Criteria Participants with MCI (Mild Cognitive Impairment) will meet criteria consistent with the criteria outlined by the NIA-Alzheimer's Association workgroup 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. Cognitive function allows independent (or minimally assisted) travel to and from walk locations In-home reliable broadband internet (for weekly online surveys). Ability to read, speak, and understand English Exclusion Criteria: Self-reported or clinically diagnosed dementia Significant disease of the central nervous system Severely depressed (CES-D score > 16), significantly symptomatic psychiatric disorder Advanced cardiovascular disease that would make walking difficult, including history of congestive heart failure Unstable insulin-dependent diabetes mellitus, received diagnosis Type 1 Diabetes, started insulin within past 3 months, hospitalized for hypoglycemia within past 6 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrice Fuller, BS

Phone

503-505-4670

fullerp@ohsu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raina Croff, PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Citations:

PubMed Identifier

29961887

Citation

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.

Results Reference

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Efficacy of a Multimodal Brain Health Intervention for Older African Americans

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