iCare4Me Transitions

University of Pennsylvania

Status and phase: Enrolling; Phase 3

Conditions: Caregiver Stress

Treatments: Behavioral: Virtual Health Coach for You; Other: Digital Health Information (DHI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06167746

1R01AG082892-01 (U.S. NIH Grant/Contract)

R01AG082892

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Digital Health Information (DHI)

Active Comparator group

Description:

Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study.

Treatment:

Other: Digital Health Information (DHI)

Virtual Health Coaching + DHI

Experimental group

Description:

Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.

Treatment:

Other: Digital Health Information (DHI)

Behavioral: Virtual Health Coach for You