Status:
NOT_YET_RECRUITING
Virtual Caregiver Coach for You (ViCCY)
Lead Sponsor:
Visiting Nurse Service of New York
Collaborating Sponsors:
University of Pennsylvania
Conditions:
Heart Failure
Cognitive Impairment
Eligibility:
All Genders
18-101 years
Phase:
NA
Brief Summary
This RCT design will enroll 254 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 ...
Detailed Description
Purpose and Specific Aims Cognitive Impairment (CI) has been reported to be as high as 78% in older adults with Heart Failure (HF). CI markedly increases the risk of adverse HF outcomes such as hospi...
Eligibility Criteria
Inclusion
- 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 or child 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
Exclusion
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
- Caregiver Exclusion Criteria 1. Non-English speaking
Key Trial Info
Start Date :
June 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2029
Estimated Enrollment :
314 Patients enrolled
Trial Details
Trial ID
NCT07220798
Start Date
June 15 2026
End Date
September 15 2029
Last Update
October 28 2025
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