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Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia (SHARP-CG)

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Completed

Conditions

Cognitive Impairment
Caregiver Burden
Depression

Treatments

Behavioral: SHARP - Physical and social activity

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05658328
P30AG024978-19 (U.S. NIH Grant/Contract)
5P30AG024978-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

Intervention Group
Experimental group
Description:
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.
Treatment:
Behavioral: SHARP - Physical and social activity
Waitlist Control
Active Comparator group
Description:
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.
Treatment:
Behavioral: SHARP - Physical and social activity

Trial contacts and locations

1

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Central trial contact

Patrice Fuller, BS; Dara Wasserman

Data sourced from clinicaltrials.gov

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