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iCare4Me Transitions

Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167746
Acronym
iCare4Me T
Enrollment
314
Registered
2023-12-12
Start date
2024-03-01
Completion date
2028-05-31
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregiver Stress

Keywords

Care Transitions, Older Adult, Health Coaching, Virtual, Self-Care, Coping

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.

Interventions

OTHERDigital Health Information (DHI)

Digital health information websites.

BEHAVIORALVirtual Health Coach for You

Study 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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

The Principal Investigator will be blinded to group assignment.

Intervention model description

This randomized single-group interventional study caregivers of recently hospitalized older adults will receive either digital health information (DHI) alone or a virtual health coaching intervention (Virtual Caregiver Coach for You, ViCCY) with DHI. Health resource data on the patients of the enrolled caregivers will be collected.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Self-Care InventoryCollected at: enrollment, 3- and 6-months after enrollmentThe 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.
Health Self-Care NeglectCollected at: enrollment, 3- and 6-months after enrollmentThis a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.

Secondary

MeasureTime frameDescription
Perceived Stress ScaleCollected at: enrollment, 3- and 6-months after enrollmentThe perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress.
Brief COPECollected at: enrollment, 3- and 6-months after enrollmentThis tool is designed to assess the varying coping strategies used by individuals in response to stress.
Caregiver Self-Care Self-Efficacy ScaleCollected at: enrollment, 3- and 6-months after enrollmentThis 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.
Preparedness for Caregiving ScaleCollected at: enrollment, 3- and 6-months after enrollmentThis 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.
Quality of the relationshipCollected at: enrollment, 3- and 6-months after enrollmentThis 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.
RAND Medical Outcomes Study Short Form (SF-36)Collected at: enrollment, 3- and 6-months after enrollmentThis scale that uses multiple measures to determine overall mental and physical health. Higher scores indicate better mental and physical health.

Countries

United States

Contacts

CONTACTKaren Hirschman, Ph.D.
hirschk@nursing.upenn.edu215-573-3755
PRINCIPAL_INVESTIGATORKaren Hirschman, Ph.D.

University of Pennsylvia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026