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Behavioural Intervention
Virtual Health Coaching + DHI for Caregiver Stress (iCare4Me T Trial)
Phase 3
Recruiting
Led By Karen Hirschman, Ph.D.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at: enrollment, 3- and 6-months after enrollment
Awards & highlights
iCare4Me T Trial Summary
This trial will compare the effectiveness of a virtual health coach intervention and digital health information to improve self-care among caregivers of hospitalized older adults transitioning from hospital to home.
Who is the study for?
This trial is for caregivers aged 18+ who provide at least 8 hours of weekly care to hospitalized adults over 65, have poor self-care habits, are willing and able to use technology, and speak English. Those with cognitive deficits, enrolled in similar trials, or with untreated major psychiatric illnesses cannot participate.Check my eligibility
What is being tested?
The study compares a virtual health coach intervention against web-based health information alone for improving self-care among caregivers of older adults transitioning from hospital to home. It will also assess the interventions' cost-effectiveness and impact on caregiver stress and confidence.See study design
What are the potential side effects?
Since this trial involves digital information and virtual coaching rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience increased screen time which could lead to eye strain or headache.
iCare4Me T Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected at: enrollment, 3- and 6-months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at: enrollment, 3- and 6-months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health Self-Care Neglect
Self-Care Inventory
Secondary outcome measures
Brief COPE
Caregiver Self-Care Self-Efficacy Scale
Perceived Stress Scale
+3 moreOther outcome measures
Experience with Care
iCare4Me T Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Health Coaching + DHIExperimental Treatment2 Interventions
Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.
Group II: Digital Health Information (DHI)Active Control1 Intervention
Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,023 Previous Clinical Trials
42,879,172 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,700 Previous Clinical Trials
28,032,560 Total Patients Enrolled
3 Trials studying Caregiver Stress
435 Patients Enrolled for Caregiver Stress
Karen Hirschman, Ph.D.Principal InvestigatorUniversity of Pennsylvia
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