Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia
SHARP-CG
A Neighborhood-based Physical and Social Activity Intervention for Older Black Caregivers and People Living With Dementia: SHARP-CG
2 other identifiers
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2024
CompletedOctober 24, 2025
October 1, 2025
1.6 years
November 11, 2022
October 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Effect on sleep health
Primary caregivers (and optionally PLWD) continuously wear an actigraphy watch for the study duration. The watch (Withings) measures heart rate variability, step-activity levels, sleep times, and sleep disturbances. 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.
16 weeks
Effect on sleep health
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.
16 weeks
Change in blood pressure
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.
16 weeks
Secondary Outcomes (1)
Effect on mental health
16 weeks
Other Outcomes (1)
Design effectiveness
16 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALCaregivers (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
ACTIVE COMPARATORCaregivers (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.
Interventions
Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence
Eligibility Criteria
You may qualify if:
- Self-identified African American (caregiver and PWD)
- Caregivers and PWD Age \> 55 years old; caregiver support person aged \>18 years old
- Caregiver and PWD 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 for at least 45 minutes without the use of mobility aids
- 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
- Cognitive function allows independent (or minimally assisted) travel to and from walk locations
- Caregivers must have in-home reliable broadband internet (for weekly online surveys).
- Ability to read, speak, and understand English - all participants
- In general good health for their age (e.g., stable cardiovascular disease, stable diabetes mellitus, no significant nervous system disease).
- Subject must have adequate vision, hearing and language abilities to complete assessments.
You may not qualify if:
- Self-reported or clinically diagnosed late-stage 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
Related Publications (2)
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.
PMID: 29961887BACKGROUNDPaula 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
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raina L Croff, PhD
OregonOHSU
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
November 11, 2022
First Posted
December 20, 2022
Study Start
March 1, 2023
Primary Completion
October 20, 2024
Study Completion
October 20, 2024
Last Updated
October 24, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share