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

Not Applicable

Completed

• Conditions: Depression; Cognitive Impairment; Caregiver Burden
• Interventions: Behavioral: SHARP - Physical and social activity

• Registration Number: NCT05658328
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-20
• Study Start: 2023-03-01
• Primary Completion: 2024-10-23
• Study Completion: 2024-10-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	SHARP - Physical and social activity	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.
Waitlist Control	SHARP - Physical and social activity	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.

Primary Outcome Measures

Name	Time	Method
Effect on sleep health	16 weeks	Primary caregivers (and optionally PLWD) use an under-the-mattress sleep sensor that measures sleep time and quality, HRV, and movement activity. Step counts (watch), total sleep time and quality (bed-mat sleep sensor), and HRV (watch and sleep sensor) will be analyzed using generalized mixed effects models with outcome being each incidence of occurrence (e.g., blue mood) or continuous outcomes (e.g., daily duration of sleep) and a time\*group interaction term.
Change in blood pressure	16 weeks	Pre-post difference in blood pressure are compared between primary caregivers in the experimental (SHARP intervention) and control groups (i.e., control (usual behavior) group waits 4 months then walks 4 months). Linear regression models with the primary and secondary outcome (BP and ZBI-12 (1°), at month 4 will be regressed on the baseline score of each outcome, the treatment group (experimental vs. control groups), controlling for caregiver age. The coefficient of the treatment group variable indicates the efficacy of the experiment.

Secondary Outcome Measures

Name	Time	Method
Effect on mental health	16 weeks	The Short Form Zarit Burden Interview (ZBI-12) is administered pre-post intervention. Pre-post difference in scores are compared between primary caregivers in the experimental (SHARP intervention) and control groups (i.e., control (usual behavior) group waits 4 months then walks 4 months). Linear regression models with the primary and secondary outcome (BP and ZBI-12 (1°), at month 4 will be regressed on the baseline score of each outcome, the treatment group (experimental vs. control groups), controlling for caregiver age. The coefficient of the treatment group variable indicates the efficacy of the experiment.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States