| NCT ID | NCT06167746 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Pennsylvania |
| Condition | Caregiver Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 314 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 314 participants in total. It began in 2024-03-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older) * Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2) * Willing to use technology (e.g., computer, smartphone, iPad/tablet) * Able to complete the protocol, e.g., adequate vision and hearing * English speaking Exclusion Criteria: * Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3) * Participation in another similar support or care transition trial * Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)
Contact & Investigator
Karen Hirschman, Ph.D.
PRINCIPAL INVESTIGATOR
University of Pennsylvia
Frequently Asked Questions
Who can join the NCT06167746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Caregiver Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06167746 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 314 participants.
Is NCT06167746 currently recruiting?
Yes, NCT06167746 is actively recruiting participants. Contact the research team at hirschk@nursing.upenn.edu for enrollment information.
Where is the NCT06167746 trial being conducted?
This trial is being conducted at Philadelphia, United States, Philadelphia, United States, Philadelphia, United States.
Who is sponsoring the NCT06167746 clinical trial?
NCT06167746 is sponsored by University of Pennsylvania. The principal investigator is Karen Hirschman, Ph.D. at University of Pennsylvia. The trial plans to enroll 314 participants.