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NCT06167746 · ClinicalTrials.gov registry record · Phase 3
iCare4Me Transitions
A Phase 3 study of Caregiver Stress, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
- 3
- Study locations
NCT06167746: Recruiting Phase 3 study of Caregiver Stress, sponsored by University of Pennsylvania.
NCT06167746 is a Phase 3 study of Caregiver Stress that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 314 participants, above the 165-participant average among 5 other Caregiver Stress trials with a reported enrollment target (90% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06167746, a Phase 3 study of Caregiver Stress, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are: 1. compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home, 2. compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and 3. explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone. Participants who enroll will agree to enroll will: * be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and * be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment. Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.
Primary Outcome
The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care.
Conditions Studied
Interventions
- OTHER Digital Health Information (DHI)
- BEHAVIORAL Virtual Health Coach for You
Study Locations (3)
Pennsylvania
- Pennsylvania Hospital - Philadelphia
- Hospital of the University of Pennsylvania - Philadelphia
- Penn Presbyterian Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 3 |
What NCT06167746 shows while recruiting
NCT06167746 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, above the 165-participant average among 5 other Caregiver Stress trials with a reported enrollment target (90% higher).
The record links to 1 condition, with Caregiver Stress appearing as the primary indexed condition, and to 2 interventions - of which Digital Health Information (DHI) is the first listed.
NCT06167746 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06167746 about?
NCT06167746 is a clinical study titled "iCare4Me Transitions". The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each...
What is the current status of trial NCT06167746?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2024-03-01. Estimated completion is 2028-05-31.
What conditions does trial NCT06167746 study?
This clinical trial studies the following conditions: Caregiver Stress.
What interventions are being tested in trial NCT06167746?
The interventions under investigation include: Digital Health Information (DHI) (OTHER), Virtual Health Coach for You (BEHAVIORAL).
Who is sponsoring clinical trial NCT06167746?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06167746 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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