Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment
Recruiting · NCT07220798 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Patient Exclusion Criteria
- Dementia (ICD-10 code for dementia)
- Enrolled in hospice
- Non-English speaking
- Caregiver Exclusion Criteria 1. Non-English speaking
Where it is running
1 location listed across 1 US state.
- VNS Health - New York, New York, United States