ViCCY: a caregiver self-care program for HF patients with cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial enrolls 256 informal caregivers (spouse/partner or child) of home health care patients with heart failure and cognitive impairment, plus 60 patient-caregiver dyads. Caregivers are randomized 1:1 to the ViCCY intervention or usual care, with stratification by sex, relationship, and race to balance potential influences on burden and stress. ViCCY consists of 10 sessions delivered over six months, using caregivers’ own devices or provided tablets with internet access. The study measures caregiver mental health and seeks to determine whether improvements in caregiver well-being translate to better patient outcomes, particularly through changes in relationship strain. Primary aims focus on caregiver outcomes; secondary aims explore patient outcomes and the mechanisms linking caregiver improvement to patient health.

Why it matters

Who can join: the full rules

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

Where it's running

• VNS Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Barbara Riegel, PhD, RN — VNS Health (formerly Visiting Nurse Service of New York)
• Study coordinator: Barbara Riegel, PhD, RN
• Email: briegel@nursing.upenn.edu
• Phone: 215.898.9927

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.