- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658328
Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia (SHARP-CG)
October 22, 2025 updated by: Raina Croff, Oregon Health and Science University
A Neighborhood-based Physical and Social Activity Intervention for Older Black Caregivers and People Living With Dementia: SHARP-CG
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence
|
|
Active Comparator: 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.
|
Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood pressure
Time Frame: 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.
|
16 weeks
|
|
Effect on sleep health
Time Frame: 16 weeks
|
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
Time Frame: 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.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect on mental health
Time Frame: 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.
|
16 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Design effectiveness
Time Frame: 16 weeks
|
Focus groups evaluate program design effectiveness for older Black dementia caregivers, including acceptance, needed adaptations, and cultural significance
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Raina L Croff, PhD, OregonOHSU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
October 20, 2024
Study Completion (Actual)
October 20, 2024
Study Registration Dates
First Submitted
November 11, 2022
First Submitted That Met QC Criteria
December 16, 2022
First Posted (Actual)
December 20, 2022
Study Record Updates
Last Update Posted (Estimated)
October 24, 2025
Last Update Submitted That Met QC Criteria
October 22, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5P30AG024978-19 (U.S. NIH Grant/Contract)
- P30AG024978-19 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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