Sustaining Home Heart Failure Palliative Care in Rural Appalachia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HF-FamPALhomeCARE.
- Who it may be relevant to
- Registry conditions: Heart Failure NYHA Class III, Heart Failure NYHA Class IV. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial (RCT).
Overview
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.
Interventions
- Behavioral 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 measures
- 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]
Secondary outcome measures (12)
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 3 Month Follow up]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 6 Month Follow up]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 9 Month Follow up]
- Patient--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 12 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 3 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 6 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 9 Month Follow up]
- Caregiver--Patient Health Questionnaire-9 (PHQ-9) [Time frame: 12 Month Follow up]
- Patient--Generalized anxiety disorder (GAD-7) [Time frame: Baseline]
- Patient--Generalized anxiety disorder (GAD-7) [Time frame: 3 Month Follow up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- West Virginia University Hospital — Morgantown
Publications
- 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 40055735
Identifiers
NCT: NCT06791850 · 2408021376 · R01NR021630