Caregiver BurdenSHARP-CGNCT05658328
Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia
A study testing SHARP - Physical and social activity in people with Caregiver Burden and Depression, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Depression, Cognitive Impairment
- What is being tested?
- SHARP - Physical and social activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the 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.
- Conditions
- Caregiver Burden, Depression, Cognitive Impairment
- Being tested
- SHARP - Physical and social activity
- Keywords
- physical activity, reminiscence, social engagement, dementia caregiver, neighborhood-based, walking, technology-enabled, sleep, geriatric depression, caregiver burden, African American
- Medical subject headings
- Caregiver Burden, Depression, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHARP - Physical and social activityBehavioural
Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: SHARP - Physical and social activity |
| Waitlist Control | Active comparator | 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. Receives: Behavioral: SHARP - Physical and social activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (1)
Effect on mental health
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start1 Mar 2023
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Raina Croff, Oregon Health and Science University
- Investigators
- Raina L Croff, PhD, Principal investigator, OregonOHSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658328
- Sponsor's protocol ID
- 5P30AG024978-19
- Other IDs
- P30AG024978-19
- Acronym
- SHARP-CG
- Status last verified
- Oct 2025
- First submitted
- 11 Nov 2022
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29961887Paula 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neighborhood-based Physical and Social Activity Intervention for Older Black Caregivers and People Living With Dementia: SHARP-CG
- ClinicalTrials.gov ID
- NCT05658328
- Acronym / sponsor ID
- SHARP-CG / 5P30AG024978-19
- Conditions
- Caregiver Burden, Depression, Cognitive Impairment
- Keywords
- physical activity, reminiscence, social engagement, dementia caregiver, neighborhood-based, walking, technology-enabled, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: SHARP - Physical and social activityCaregivers (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 comparator | Behavioral: SHARP - Physical and social activityCaregivers (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHARP - Physical and social activityTechnology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence | Behavioural | Intervention Group, Waitlist Control |
Primary outcome
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.
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.
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.
1 secondary outcome
Effect on mental health
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Background: PubMed 29961887Croff 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.
- BackgroundPaula 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
- SHARP study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raina L Croff, PhD principal investigator
OregonOHSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHARP - Physical and social activity in people with Caregiver Burden and Depression, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on sleep health (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.