Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia

NCT ID: NCT05658328

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-20

Brief Summary

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The Sharing History through Active Reminiscence and Photo-imagery (SHARP) Program engages triads (primary caregiver, person living with dementia, caregiver support person) in walking and social reminiscence, using a group tablet to access routes and historical neighborhood images serving as conversational prompts. Focus is on adapting the SHARP model to older Black dementia caregivers and on caregiver physical and mental health. Study technology measures sleep and daily step count. Weekly online surveys assess health status. Pre-post assessments measure cognitive function and mental health. Focus groups assess adaptation needs, feasibility and acceptance, and cultural significance.

Detailed Description

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The Sharing History through Active Reminiscence and Photo-imagery (SHARP) Program is a recently developed culturally celebratory, multimodal approach to physical, social, and reminiscence activity. The SHARP walking application, accessed on a group tablet, is preloaded with 72 themed, 1-mile neighborhood routes with GPS-linked "Memory Markers," historical neighborhood images and questions, to prompt conversational reminiscence about Black life, history, and culture. In this Stage I study, walking triads consist of a healthy or mildly cognitively impaired (MCI) primary dementia caregiver (aged 55+), the care partner - a person living with early-stage dementia (PLWD) or MCI (aged 55+), and a healthy or MCI caregiver support person (aged 18+). Triads walk 3x/week over 16 weeks in the gentrifying, historically Black neighborhoods of Portland, Oregon. The primary caregiver wears an actigraphy watch, uses an under-the-mattress sleep sensor, and on a weekly basis, measures weight on a study-provided digital scale and completes a health update survey. Watch, sleep sensor, and weekly measures are optional for the PLWD. We aim to (1) adapt SHARP implementation, technology, and protocol for caregivers of PLWD, and (2) test preliminary efficacy of this intervention on dementia caregivers' physical and mental health.

Conditions

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Caregiver Burden Depression Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Triads are randomized into either the intervention group or the waitlist control group. The intervention group walks for 16 weeks. The waitlist control group completes baseline measures for 16 weeks then continues measures while walking 16 weeks. Wearable technology and weekly surveys are optional for PLWD.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention Group

Caregivers (MCI or healthy) randomized into this group walk 3x/week for 16 weeks with their care-partner (person living with early-stage dementia - PLWD) and their caregiver support person (MCI or healthy). Caregivers (and optionally for PLWD), wears an actigraphy watch, uses an under-the-mattress sleep sensor, and on a weekly basis completes weight and a health update survey. Mid- and end-study focus groups evaluate program effectiveness and needed adaptations.

Group Type EXPERIMENTAL

SHARP - Physical and social activity

Intervention Type BEHAVIORAL

Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence

Waitlist Control

Caregivers (MCI or healthy) randomized into this group first complete baseline measures for 16 weeks, consisting of wearing an actigraphy watch, using an under-the-mattress sleep sensor, and, on a weekly basis, completing weight and a health update survey. These baseline measures are optional for PLWD. After 16 weeks of baseline data collection, the primary caregiver continues these measures while walking 3x/week for 16 weeks with their triad. The PLWD optionally completes measures and optionally wears the watch and sleep sensor. Mid- and end-study focus groups during the walking phase evaluate program effectiveness and needed adaptations.

Group Type ACTIVE_COMPARATOR

SHARP - Physical and social activity

Intervention Type BEHAVIORAL

Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence

Interventions

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SHARP - Physical and social activity

Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Self-identified African American (caregiver and PWD)
2. Caregivers and PWD Age \> 55 years old; caregiver support person aged \>18 years old
3. Caregiver and PWD 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 for at least 45 minutes without the use of mobility aids
5. Meeting Cognition Criteria

a. Participants with MCI or early-stage/mild dementia will meet criteria consistent with those defined by Jak et al. and with the criteria outlined by the NIA-Alzheimer's Association workgroup
6. Cognitive function allows independent (or minimally assisted) travel to and from walk locations
7. Caregivers must have in-home reliable broadband internet (for weekly online surveys).
8. Ability to read, speak, and understand English - all participants
9. In general good health for their age (e.g., stable cardiovascular disease, stable diabetes mellitus, no significant nervous system disease).
10. Subject must have adequate vision, hearing and language abilities to complete assessments.

Exclusion Criteria

1. Self-reported or clinically diagnosed late-stage 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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Raina Croff

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raina L Croff, PhD

Role: PRINCIPAL_INVESTIGATOR

OregonOHSU

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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)

Paula Carder, Raina Croff, Aliza Tuttle & Juell Towns (2022) Walking and Talking: Recommendations for Doing Mobile Interviews with Older Adults, Journal of Aging and Environment, DOI: 10.1080/26892618.2022.2030844

Reference Type BACKGROUND

Related Links

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Other Identifiers

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P30AG024978-19

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5P30AG024978-19

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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