NCT07220798 Improving Self-Care of Caregivers of Adults in Homecare With Heart Failure and Cognitive Impairment
| NCT ID | NCT07220798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Visiting Nurse Service of New York |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 316 participants |
| Start Date | 2026-05-28 |
| Primary Completion | 2030-04-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 316 participants in total. It began in 2026-05-28 with a primary completion date of 2030-04-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Patient Inclusion Criteria 1. Older adults (=\>50 years of age) 2. Enrolled in Home Health Care 3. Documented to have HF 4. Mild to moderate CI on the BIMS or OASIS items 5. Able to provide informed consent 6. Able to provide self-report data * Caregiver Inclusion Criteria 1. Adults (=\>18 years of age) 2. Spouse/partner/child or other informal caregiver living with or in close proximity to the patient 3. Caregiver of a home care patient who is currently receiving or recently received services and who has mild to severe cognitive impairment 4. Reporting poor self-care on screening (Health Self-Care Neglect scale score =\>2) 5. Reporting poor mental health on screening (screened with the PROMIS Global Mental Health 4a score \<12) 6. Caregiving or supporting the patient at least 8 hours/week 7. Able to complete the protocol, e.g., adequate vision and hearing, English speaking. 8. Able to provide informed consent 9. Able to use technology Exclusion Criteria: * Patient Exclusion Criteria 1. Dementia (ICD-10 code for dementia) 2. Enrolled in hospice 3. Non-English speaking * Caregiver Exclusion Criteria 1. Non-English speaking
Contact & Investigator
Barbara Riegel, PhD, RN
PRINCIPAL INVESTIGATOR
VNS Health (formerly Visiting Nurse Service of New York)
Frequently Asked Questions
Who can join the NCT07220798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 101 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07220798 currently recruiting?
Yes, NCT07220798 is actively recruiting participants. Contact the research team at briegel@nursing.upenn.edu for enrollment information.
Where is the NCT07220798 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07220798 clinical trial?
NCT07220798 is sponsored by Visiting Nurse Service of New York. The principal investigator is Barbara Riegel, PhD, RN at VNS Health (formerly Visiting Nurse Service of New York). The trial plans to enroll 316 participants.
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