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Completed

NCT Number: NCT05658328

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHARP - Physical and social activity

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Design effectiveness

    Time frame: 16 weeks

    Focus groups evaluate program design effectiveness for older Black dementia caregivers, including acceptance, needed adaptations, and cultural significance

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Neighborhood-based Physical and Social Activity Intervention for Older Black Caregivers and People Living With Dementia: SHARP-CG

Acronym: SHARP-CG

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2022
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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