Clinical trial NCT06167746: iCare4Me Transitions
Official title: Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Caregiver Stress
Keywords: Care Transitions
Older Adult
Health Coaching
Virtual
Self-Care
Coping
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Primary outcomes:
measure: Self-Care Inventory
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
measure: Health Self-Care Neglect
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
measure: Brief COPE
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
measure: Caregiver Self-Care Self-Efficacy Scale
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
measure: Preparedness for Caregiving Scale
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
measure: Quality of the relationship
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
measure: RAND Medical Outcomes Study Short Form (SF-36)
timeFrame: Collected at: enrollment, 3- and 6-months after enrollment
Other outcomes:
measure: Experience with Care
timeFrame: Collected at 1 month post index-hospital discharge
Locations:
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvia
name: Karen Hirschman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: