iCare4Me Transitions
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- University of Pennsylvania
- Study ID
- NCT06167746
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Caregiver Stress
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Digital Health Information (DHI) — OTHERDigital health information websites.
- Virtual Health Coach for You — BEHAVIORALStudy participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping.
Study Details
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.
Key Dates
- Start date
- Mar 1, 2024
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2027
- Completion
- May 31, 2028
Study Design
- Enrollment
- 314 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Active Comparator: Digital Health Information (DHI)Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study.
- Experimental: Virtual Health Coaching + DHIStudy participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.
Primary Outcome Measure
Self-Care Inventory [ Time Frame: Collected at: enrollment, 3- and 6-months after enrollment ]
Central Contacts
- Karen Hirschman, Ph.D.215-573-3755
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19104-4212 |
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