iCare4Me Transitions
- Conditions
- Caregiver Stress
- Interventions
- Other: Digital Health Information (DHI)Behavioral: Virtual Health Coach for You
- Registration Number
- NCT06167746
- Lead Sponsor
- University of Pennsylvania
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Digital Health Information (DHI) 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. Virtual Health Coaching + DHI Digital Health Information (DHI) Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months. Virtual Health Coaching + DHI Virtual Health Coach for You Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.
- Primary Outcome Measures
Name Time Method Health Self-Care Neglect Collected at: enrollment, 3- and 6-months after enrollment This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.
Self-Care Inventory Collected at: enrollment, 3- and 6-months after enrollment 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.
- Secondary Outcome Measures
Name Time Method Preparedness for Caregiving Scale Collected at: enrollment, 3- and 6-months after enrollment This scale measures how prepared caregivers feel to provide support for their loved ones in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most prepared in that area.
RAND Medical Outcomes Study Short Form (SF-36) Collected at: enrollment, 3- and 6-months after enrollment This scale that uses multiple measures to determine overall mental and physical health. Higher scores indicate better mental and physical health.
Brief COPE Collected at: enrollment, 3- and 6-months after enrollment This tool is designed to assess the varying coping strategies used by individuals in response to stress.
Perceived Stress Scale Collected at: enrollment, 3- and 6-months after enrollment The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress.
Caregiver Self-Care Self-Efficacy Scale Collected at: enrollment, 3- and 6-months after enrollment This scale measures caregiving self-efficacy in multiple areas. Each item is measured on a scale of 1-5 with 5 indicating they are the most confident in that area.
Quality of the relationship Collected at: enrollment, 3- and 6-months after enrollment This scale measures giving and receiving support in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most positive in that area.
Trial Locations
- Locations (3)
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States