Sustaining Home Heart Failure Palliative Care in Rural Appalachia

Not Applicable

Recruiting

• Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class IV

• Registration Number: NCT06791850
• Lead Sponsor: West Virginia University

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.

Study Timeline

• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Study Start: 2025-04-01
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2028-04
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	12 Month Follow Up	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.
Patient--World Health Organization Quality of life Questionnaire	12 Month Follow up	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.
Caregiver--World Health Organization Quality of life Questionnaire	12 Month Follow up	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.

Secondary Outcome Measures

Name	Time	Method
Patient--Patient Health Questionnaire-9 (PHQ-9)	12 Month Follow up	Patient Assessed: The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, and measure the severity of depression. It consists of nine questions with each question scored from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms.
Caregiver--Patient Health Questionnaire-9 (PHQ-9)	12 Month Follow up	Caregiver Assessed: The Patient Health Questionnaire-9 (PHQ-9) is a self-administered tool used to screen, diagnose, and measure the severity of depression. It consists of nine questions with each question scored from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptoms.
Patient--Generalized anxiety disorder (GAD-7)	12 Month Follow up	Patient Assessed: The Generalized Anxiety Disorder 7-item (GAD-7) scale is a self-administered questionnaire designed to screen for and measure the severity of generalized anxiety disorder (GAD). It consists of seven items that assess how often the respondent has been bothered by various anxiety symptoms. Each item is scored on a scale from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). Overall score range of 0-21 with a higher score indicating greater anxiety symptoms.
Caregiver--Generalized anxiety disorder (GAD-7)	12 Month Follow up	Caregiver Assessed: The Generalized Anxiety Disorder 7-item (GAD-7) scale is a self-administered questionnaire designed to screen for and measure the severity of generalized anxiety disorder (GAD). It consists of seven items that assess how often the respondent has been bothered by various anxiety symptoms. Each item is scored on a scale from 0 to 3 (0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day). Overall score range of 0-21 with a higher score indicating greater anxiety symptoms.
Patient--Integrated Palliative care Outcome Scale (IPOS)	12 Month Follow up	Patient reported: Integrated Palliative care Outcome Scale (IPOS) is a holistic assessment used to measure the symptoms and concerns of patients receiving palliative care. Each item is scored based on the patient's response, typically on a scale from 0 to 4 with an overall score range of 0 to 68. A higher overall score indicates more palliative care problems or concerns.
Caregiver--Integrated Palliative care Outcome Scale (IPOS)	12 Month Follow up	Caregiver reported: Integrated Palliative care Outcome Scale (IPOS) is a holistic assessment used to measure the symptoms and concerns of caregivers receiving palliative care. Each item is scored based on the patient's response, typically on a scale from 0 to 4 with an overall score range of 0 to 68. A higher overall score indicates more palliative care problems or concerns.
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)	12 Month Follow up	Assessment of spiritual well-being of patient managing chronic health conditions. Consists of 12 items with each item rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much). Total score range is 0 to 48 with higher score indicating higher spiritual well-being.
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)	12 Month Follow up	Assessment of spiritual well-being of caregiver managing chronic health conditions. Consists of 12 items with each item rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (very much). Total score range is 0 to 48 with higher score indicating higher spiritual well-being.
The Zarit Burden Interview (ZBI-12)	12 Month Follow up	The ZBI-12 consists of 12 questions that caregivers answer based on how often they experience certain feelings related to their caregiving role. Each question is scored on a scale from 0 (never) to 4 (nearly always), with the total score ranging from 0 to 48 with a higher score indicating greater burden.

Trial Locations

Locations (1)

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States