Sustaining Home Heart Failure Palliative Care in Rural Appalachia

NCT ID: NCT06791850

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-05-31

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.

Detailed Description

This study uses a randomized control trial (RCT) design to test the integrated nurse-led intervention bundle of home palliative care intervention (HF-FamPALhomeCARE) for patients with heart failure (HF) and their family caregivers. (104 patient-family caregiver dyads).

The researcher will compare HF-FamPALhomeCARE to the standard control group to see if the participants in HF-FamPALhomeCARE group will report better health outcomes than the standard control group at the completion of the study at 12 months.

Aim 1: Compared to the control group at 3, 6, 9 months, and 1-year follow-up:

Hypothesis 1a. The patients in the intervention group will have higher scores on HF-related health quality-of-life measure and on the World Health Organization (WHO) aging functional health well-being scale.

Hypothesis 1b. The family caregivers in the intervention group will have higher scores on the World Health Organization (WHO) aging functional health well-being scale.

Aim 2: Compared to the control group at 3, 6, 9 months, and 1-year follow-up:

Hypothesis 2a. The patients in the intervention group will have (a) lower depression and anxiety scores and (b) higher numbers of signed EOL advance directives.

Hypothesis 2b. The family caregivers in the intervention group will have (a) lower depression and anxiety scores, (b) lower home caregiving burden scores, and (c) improved home HF EOLPC preparedness and improved home palliative care scores.

All participants receive standard care, which is routine HF instruction from their care providers. The HF-FamPALhomeCARE group receives 5-session intervention includes 2 home visits, and 3 bi-weekly telephone calls on HF home EOLPC care. Three follow-up telephone calls will be provided at 3, 6, 9, and 12 months. Control subjects will receive the same HF home care information after 12-month. Data collection for both groups are conducted at baseline, 3, 6, 9, and 12 months.

Conditions

Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

HF-FamPALhomeCARE

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Ubolrat Piamjariyakul

Associate Dean for Research and Scholarship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ubolrat Piamjariyakul

Role: PRINCIPAL_INVESTIGATOR

West Virginia University School of Nursing

Locations

West Virginia University Hospital

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ubolrat Piamjariyakul

Role: CONTACT

ubolrat.piamjariyakul@hsc.wvu.edu

304.293.6729

Stephanie Young

Role: CONTACT

sayers1@hsc.wvu.edu

304.581.1802

Facility Contacts

Stephanie Young, MS

Role: primary

sayers1@hsc.wvu.edu

References

Piamjariyakul U, Young S, Smothers A, Wen S, Navia RO, Sokos G, Hendrickson AE, Fink P, Niland D, Hottle M, Giolzetti AC, Smith CE. Study protocol of sustaining home palliative care for patients with Heart Failure (HF) and their family caregivers in rural Appalachia: a mixed methods randomized clinical trial. BMC Palliat Care. 2025 Mar 7;24(1):56. doi: 10.1186/s12904-025-01680-y.

Reference Type: DERIVED

PMID: 40055735 (View on PubMed)

Other Identifiers

R01NR021630

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2408021376

Identifier Type: -

Identifier Source: org_study_id