Home palliative care for heart failure patients in rural Appalachia
Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial (RCT).
NA · West Virginia University · NCT06791850
This study tests a new home care program for families taking care of loved ones with advanced heart failure in rural Appalachia to see if it improves their quality of life and reduces stress over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | West Virginia University (other) |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT06791850 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests an integrated nurse-led intervention bundle designed for family home care management of end-stage heart failure in rural Appalachia. The study involves a randomized controlled trial comparing the new home palliative care intervention (HF-FamPALhomeCARE) with standard care for patients with advanced heart failure and their family caregivers. The aim is to assess improvements in health-related quality of life, caregiver burden, and mental health outcomes over a 12-month period. The trial will include 104 patient-family caregiver dyads and will evaluate various health metrics at multiple follow-up points.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 80 years with advanced heart failure (NYHA Class III or IV) and their caregivers aged 45 to 80 years.
Not a fit: Patients who have received a heart transplant, are on a waiting list for a transplant or LVAD, or have a terminal illness or dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and mental health outcomes for heart failure patients and their caregivers in rural areas.
How similar studies have performed: Other studies have shown success with similar nurse-led palliative care interventions, particularly in improving patient and caregiver outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients' age between 50 to 80 years with advanced HF (NYHA III or IV), diagnosed by physician 2. Caregivers' age between 45 to 80 years. 3. Alert and consent to participate 4. Able to read and understand English Exclusion Criteria: 1. Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD) 2. Diagnosed with a terminal illness or dementia, such as Alzheimer's disease
Where this trial is running
Morgantown, West Virginia
- West Virginia University Hospital — Morgantown, West Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Ubolrat Piamjariyakul — West Virginia University School of Nursing
- Study coordinator: Ubolrat Piamjariyakul
- Email: ubolrat.piamjariyakul@hsc.wvu.edu
- Phone: 304.293.6729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure NYHA Class III, Heart Failure NYHA Class IV, advanced heart failure, home palliative care, family caregiver, rural Appalachia