NCT06791850

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Apr 2025May 2028

First Submitted

Initial submission to the registry

January 19, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

January 19, 2025

Last Update Submit

March 5, 2026

Conditions

Heart Failure NYHA Class IIIHeart Failure NYHA Class IV

Keywords

advanced heart failurehome palliative carefamily caregiverrural Appalachia

Outcome Measures

Primary Outcomes (15)

  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.

    Baseline

  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.

    3 Month Follow up

  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.

    6 Month Follow up

  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.

    9 Month Follow up

  • Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Measures patients' Heart Failure (HF) status \& physical function status. Each item is scored on a scale from 0 to 4 or 0 to 5, depending on the question. The overall score range is 0-100 with a higher score indicating better HF health status.

    12 Month Follow Up

  • Patient--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    Baseline

  • Patient--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    3 Month Follow up

  • Patient--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    6 Month Follow up

  • Patient--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    9 Month Follow up

  • Patient--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    12 Month Follow up

  • Caregiver--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    Baseline

  • Caregiver--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    3 Month Follow up

  • Caregiver--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    6 Month Follow up

  • Caregiver--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    9 Month Follow up

  • Caregiver--World Health Organization Quality of life Questionnaire

    Self-assessment that measures patient's function health and well-being. Score range is 0-100 with a higher score indicating better health function and well-being.

    12 Month Follow up

Secondary Outcomes (45)

  • Patient--Patient Health Questionnaire-9 (PHQ-9)

    Baseline

  • Patient--Patient Health Questionnaire-9 (PHQ-9)

    3 Month Follow up

  • Patient--Patient Health Questionnaire-9 (PHQ-9)

    6 Month Follow up

  • Patient--Patient Health Questionnaire-9 (PHQ-9)

    9 Month Follow up

  • Patient--Patient Health Questionnaire-9 (PHQ-9)

    12 Month Follow up

  • +40 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

HF-FamPALhomeCARE

EXPERIMENTAL

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.

Behavioral: HF-FamPALhomeCARE

Interventions

HF-FamPALhomeCAREBEHAVIORAL

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.

HF-FamPALhomeCARE

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients' age between 50 to 80 years with advanced HF (NYHA III or IV), diagnosed by physician
  • Caregivers' age between 45 to 80 years.
  • Alert and consent to participate
  • Able to read and understand English

You may not qualify if:

  • Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)
  • Diagnosed with a terminal illness or dementia, such as Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40055735DERIVED

Study Officials

  • Ubolrat Piamjariyakul

    West Virginia University School of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ubolrat Piamjariyakul

CONTACT

304.293.6729ubolrat.piamjariyakul@hsc.wvu.edu

Stephanie Young

CONTACT

304.581.1802sayers1@hsc.wvu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Care provider and outcome assessor including data collectors will be blinded to group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a low-risk randomized control trial design to test the outcomes of the HF-FamPALhomeCARE bundled intervention with advanced HF patients and their primary family caregivers in the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Research and Scholarship

Study Record Dates

First Submitted

January 19, 2025

First Posted

January 24, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

To enhance the transparency, and reproducibility of the research, the de-identified dataset, project data descriptions, and statistical models generated by this R01 will be shared. These data will be shared in the appropriate NIH repository the National Archive of Computerized Data on Aging (NACDA) hosted by ICPSR. The description of the data management plan is also submitted.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Study protocol and SAP will be shared via ClinicalTrials.gov and published protocol manuscript. The Analysis codes will be made available at the end of the project period and at the time of publication.
Access Criteria
There is no public access to the database during the trial period. This project's scientific data will be available on the NACDA NIH Repository 5 years after the end of the funding period.

Locations

US(1)