Clinical trial NCT05658328: Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia
Official title: A Neighborhood-based Physical and Social Activity Intervention for Older Black Caregivers and People Living With Dementia: SHARP-CG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Depression
Cognitive Impairment
Keywords: physical activity
reminiscence
social engagement
dementia caregiver
neighborhood-based
walking
technology-enabled
sleep
geriatric depression
caregiver burden
African American
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-12-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effect on sleep health
timeFrame: 16 weeks
measure: Effect on sleep health
timeFrame: 16 weeks
measure: Change in blood pressure
timeFrame: 16 weeks
Secondary outcomes:
measure: Effect on mental health
timeFrame: 16 weeks
Other outcomes:
measure: Design effectiveness
timeFrame: 16 weeks
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: OregonOHSU
name: Raina L Croff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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