NCT07220798Recruiting
Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment
Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment (iCare4Me Homecare)
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 316 (estimated)
- First submitted
- 22 Oct 2025
- Start date
- May 2026
- Primary completion date
- Apr 2030
- Lead sponsor
- Visiting Nurse Service of New York
- Diseases
- Heart failure
- NCT number
- NCT07220798
What you commit to
- Study type: Interventional
- Planned participants: 316
- From May 2026 to the primary completion date, Apr 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
Other
- Caregiver Exclusion Criteria 1. Non-English speaking
Who the study is looking for
- Patient Inclusion Criteria
- Older adults (=\>50 years of age)
- Enrolled in Home Health Care
- Documented to have HF
- Mild to moderate CI on the BIMS or OASIS items
- Able to provide informed consent
- Able to provide self-report data
- Caregiver Inclusion Criteria
- Adults (=\>18 years of age)
- Spouse/partner/child or other informal caregiver living with or in close proximity to the patient
- Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment
- Reporting poor self-care on screening (Health Self-Care Neglect scale score =\>2)
- Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score \<12)
- Caregiving or supporting the patient at least 8 hours/week
- Able to complete the protocol, e.g., adequate vision and hearing, English speaking.
- Able to provide informed consent
- Able to use technology
Age in the registry: 18 years to 101 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VNS Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.