Clinical Trial

Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment

Study acronym: iCare4Me HC
Recruiting
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Summary
This RCT design will enroll 256 informal caregivers (spouse/partner or child) of HHC patients with HF/CI and 60 patients with HF and mild to moderate CI (60 dyads). After collecting baseline data, we will block randomize the caregivers 1:1 to the ViCCY intervention or comparator group, stratifying randomization by caregiver sex (male/female), relationship (spouse/partner or child), and race (white/other)- factors known to influence caregiving burden, perceived stress, and receptivity to the intervention. We will encourage caregivers to use their own devices but provide tablet devices with wireless network access if needed. The intervention group will receive 10 sessions of ViCCY over 6 months.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-13
notable Primary completion pushed: 2028-06-14 -> 2030-04-28 2026-08-13
minor Completion pushed: 2029-09-15 -> 2030-04-28 2026-08-13
Trial Details
NCT Number NCT07220798
Lead Sponsor Visiting Nurse Service of New York
Collaborators: University of Pennsylvania
Conditions Heart Failure, Cognitive Impairment, Caregiver Burden
Enrollment 316 participants
Start Date 2026-05-28
Primary Completion 2030-04-28 (estimated)
Study Completion 2030-04-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-12