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

Primary Purpose

Caregiver Burden, Depression, Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHARP - Physical and social activity
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caregiver Burden focused on measuring physical activity, reminiscence, social engagement, dementia caregiver, neighborhood-based, walking, technology-enabled, sleep, geriatric depression, caregiver burden, African American

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oregon Health & Science UniversityRecruiting
  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Waitlist Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 11, 2022
Last Updated
May 9, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05658328
Brief Title
Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia
Acronym
SHARP-CG
Official Title
A Neighborhood-based Physical and Social Activity Intervention for Older Black Caregivers and People Living With Dementia: SHARP-CG
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
SHARP - Physical and social activity
Intervention Description
Technology-enabled neighborhood walking 3x/week for 16 weeks with conversational reminiscence
Primary Outcome Measure Information:
Title
Effect on sleep health
Description
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.
Time Frame
16 weeks
Title
Effect on sleep health
Description
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.
Time Frame
16 weeks
Title
Change in blood pressure
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Effect on mental health
Description
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.
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Design effectiveness
Description
Focus groups evaluate program design effectiveness for older Black dementia caregivers, including acceptance, needed adaptations, and cultural significance
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dara Wasserman
Phone
503-494-7616
Email
wassermd@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patrice Fuller, BS
Phone
503-494-2367
Email
fullerp@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raina L Croff, PhD
Organizational Affiliation
OregonOHSU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice Fuller, BS
Phone
503-494-2367
Email
fullerp@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Joan Benedict
Email
benedicj@ohsu.edu
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrice M Fuller, BS
Phone
503-505-4670
Email
fullerp@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Charles Fennell, BS
Phone
541-399-2846
Email
fennelch@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29961887
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.
Results Reference
background
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
Results Reference
background
Links:
URL
http://www.sharpwalkingstudy.org
Description
SHARP study website

Learn more about this trial

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

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