iCare4Me Transitions
ConditionCaregiver Stress
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Digital Health Information (DHI)
Other interventionDigital health information websites.
Virtual Health Coach for You
BehavioralStudy 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.
Treatment groups
314 Participants
are divided into 2 treatment groupsGroup A: Digital Health Information (DHI)Active comparator 1 intervention
Group B: Virtual Health Coaching + DHIExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Self-Care Inventory
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.
Time frame
Collected at: enrollment, 3- and 6-months after enrollment2
Health Self-Care Neglect
This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.
Time frame
Collected at: enrollment, 3- and 6-months after enrollmentSecondary outcomes
1
Perceived Stress Scale
The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress.
Time frame
Collected at: enrollment, 3- and 6-months after enrollment2
Brief COPE
This tool is designed to assess the varying coping strategies used by individuals in response to stress.
Time frame
Collected at: enrollment, 3- and 6-months after enrollment3
Caregiver Self-Care Self-Efficacy Scale
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.
Time frame
Collected at: enrollment, 3- and 6-months after enrollment4
Preparedness for Caregiving Scale
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.
Time frame
Collected at: enrollment, 3- and 6-months after enrollmentOther outcomes
1
Experience with Care
This 10-item tool evaluates the experience with care post-hospital discharge. Each item is measured on a scale of 1-4 with 4 indicating they strongly agree with each statement.
Time frame
Collected at 1 month post index-hospital discharge2
Acute care resource use outcomes for patients of caregivers
Hospitalizations and emergency department visits or the patients of caregivers during the 6 months after the caregiver enrolls.
Time frame
Data over 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov