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Physical and Social Activity Program for Dementia Caregivers (SHARP-CG Trial)

N/A

Recruiting

Led By Raina L Croff, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

SHARP-CG Trial Summary

This trial studies how a program of walking and reminiscing can help Black caregivers of those with dementia improve their physical and mental health. Technology measures sleep and steps, and surveys assess health and cognitive function. Focus groups assess the program's adaptation, feasibility and cultural significance.

Who is the study for?

This trial is for older Black caregivers and those living with dementia, over 55 years old, who can walk unaided for at least 45 minutes. They should be in generally good health, speak English, have reliable internet at home, and have lived in Portland's historically Black neighborhoods for over a decade.Check my eligibility

What is being tested?

The SHARP program is being tested to see if it helps with physical and mental health by getting participants to walk and engage in social reminiscence using historical neighborhood images as conversation starters. It includes technology to track sleep and steps plus weekly surveys on health.See study design

What are the potential side effects?

Since the intervention involves physical activity (walking) and social interaction through reminiscence activities, potential side effects may include typical risks associated with mild exercise such as muscle strain or fatigue.

SHARP-CG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in blood pressure

Effect on sleep health

Secondary outcome measures

Effect on mental health

Other outcome measures

Design effectiveness

SHARP-CG Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Waitlist ControlActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

6,845,969 Total Patients Enrolled

Raina L Croff, PhDPrincipal InvestigatorOregonOHSU

Media Library

SHARP - Physical and social activity Clinical Trial Eligibility Overview. Trial Name: NCT05658328 — N/A

Cognitive Impairment Research Study Groups: Intervention Group, Waitlist Control

Cognitive Impairment Clinical Trial 2023: SHARP - Physical and social activity Highlights & Side Effects. Trial Name: NCT05658328 — N/A

SHARP - Physical and social activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05658328 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical experiment presently enlisting participants?

"The trial, which was initially listed on the 5th of January 2023, is not currently seeking participants. The last update to this study was made on December 16th 2022. Despite that fact, there are still a multitude of other clinical trials open for enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Raina Croff 2023. "Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05658328.

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