Recruiting

Palliative Care

Sponsor:

West Virginia University

Code:

NCT06791850

Conditions

Heart Failure NYHA Class III

Heart Failure NYHA Class IV

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

HF-FamPALhomeCARE

Study Details

Brief summary:

The aim of this mixed methods randomized controlled trial is to test the integrated nurse-led intervention bundle for family home care management of end-stage heart failure and palliative care in rural Appalachia. This intervention bundle is designed to address rural disparities in access to health care, with the help of the faith-based nurses and local volunteer visiting neighbors.

Conditions

Heart Failure NYHA Class III

Heart Failure NYHA Class IV

Study ID

NCT06791850

Start date

Apr 1, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Control

Participants in control group receive standard care which is routine HF instruction at primary providers or specialist's clinic appointments.

experimental: HF-FamPALhomeCARE

HF-FamPALcare intervention group will receive standard care plus 2 home visits and 3 bi-weekly telephone calls on HF home EOLPC care, and follow-up telephone calls at 3, 6, 9, and 12 months.

Interventions

HF-FamPALhomeCARE

Participants in HF-FamPALhomeCARE Intervention group receive standard care plus 2 home visits, 3 bi-weekly telephone call on HF home EOLPC care, and follow-up telephone calls at 3, 6, 9, and 12 months.

Primary outcome measure

  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: Baseline ]
  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: 3 Month Follow up ]
  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: 6 Month Follow up ]
  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: 9 Month Follow up ]
  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: 12 Month Follow Up ]
  • Patient--World Health Organization Quality of life Questionnaire [ Time Frame: Baseline ]
  • Patient--World Health Organization Quality of life Questionnaire [ Time Frame: 3 Month Follow up ]
  • Patient--World Health Organization Quality of life Questionnaire [ Time Frame: 6 Month Follow up ]
  • Patient--World Health Organization Quality of life Questionnaire [ Time Frame: 9 Month Follow up ]
  • Patient--World Health Organization Quality of life Questionnaire [ Time Frame: 12 Month Follow up ]
  • Caregiver--World Health Organization Quality of life Questionnaire [ Time Frame: Baseline ]
  • Caregiver--World Health Organization Quality of life Questionnaire [ Time Frame: 3 Month Follow up ]
  • Caregiver--World Health Organization Quality of life Questionnaire [ Time Frame: 6 Month Follow up ]
  • Caregiver--World Health Organization Quality of life Questionnaire [ Time Frame: 9 Month Follow up ]
  • Caregiver--World Health Organization Quality of life Questionnaire [ Time Frame: 12 Month Follow up ]

Central Contacts and Locations

Central contacts

Ubolrat Piamjariyakul

304.293.6729ubolrat.piamjariyakul@hsc.wvu.edu

Stephanie Young

304.581.1802sayers1@hsc.wvu.edu

Locations

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Stephanie Young, MS

sayers1@hsc.wvu.edu

More Information

Sponsor

West Virginia University

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • advanced heart failure
  • home palliative care
  • family caregiver
  • rural Appalachia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-03-09.