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iCare4Me Transitions

Study acronym: iCare4Me T
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv8
  2. Minor Enrollment target: 250 to 314v7
  3. Minor Site contacts updated at 3 of 3 sitesv6
  4. Minor Study sites: 2 to 3v5
  5. Minor Study sites: 1 to 2v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  2. Minor Interventions: Digital Health Information (Other), Virtual Health Coach for You (Behavioral) to Digital Health Information (DHI) (Other), Virtual Health Coach for You (Behavioral) Secondary endpoints: details revised at 4 of 6 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 4 of 6 entries
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06167746
Lead Sponsor University of Pennsylvania
Collaborators: National Institute on Aging (NIA)
Conditions Caregiver Stress
Enrollment 314 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov