Clinical trial NCT06791850: Sustaining Home Heart Failure Palliative Care in Rural Appalachia
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Keywords: advanced heart failure
home palliative care
family caregiver
rural Appalachia
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-01-24
Enrollment: 208
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: Baseline
measure: Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 3 Month Follow up
measure: Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 6 Month Follow up
measure: Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 9 Month Follow up
measure: Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 12 Month Follow Up
measure: Patient--World Health Organization Quality of life Questionnaire
timeFrame: Baseline
measure: Patient--World Health Organization Quality of life Questionnaire
timeFrame: 3 Month Follow up
measure: Patient--World Health Organization Quality of life Questionnaire
timeFrame: 6 Month Follow up
measure: Patient--World Health Organization Quality of life Questionnaire
timeFrame: 9 Month Follow up
measure: Patient--World Health Organization Quality of life Questionnaire
timeFrame: 12 Month Follow up
measure: Caregiver--World Health Organization Quality of life Questionnaire
timeFrame: Baseline
measure: Caregiver--World Health Organization Quality of life Questionnaire
timeFrame: 3 Month Follow up
measure: Caregiver--World Health Organization Quality of life Questionnaire
timeFrame: 6 Month Follow up
measure: Caregiver--World Health Organization Quality of life Questionnaire
timeFrame: 9 Month Follow up
measure: Caregiver--World Health Organization Quality of life Questionnaire
timeFrame: 12 Month Follow up
Secondary outcomes:
measure: Patient--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Patient--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 Month Follow up
measure: Patient--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 Month Follow up
measure: Patient--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 9 Month Follow up
measure: Patient--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 Month Follow up
measure: Caregiver--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Caregiver--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 Month Follow up
measure: Caregiver--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 Month Follow up
measure: Caregiver--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 9 Month Follow up
measure: Caregiver--Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 Month Follow up
measure: Patient--Generalized anxiety disorder (GAD-7)
timeFrame: Baseline
measure: Patient--Generalized anxiety disorder (GAD-7)
timeFrame: 3 Month Follow up
measure: Patient--Generalized anxiety disorder (GAD-7)
timeFrame: 6 Month Follow up
measure: Patient--Generalized anxiety disorder (GAD-7)
timeFrame: 9 Month Follow up
measure: Patient--Generalized anxiety disorder (GAD-7)
timeFrame: 12 Month Follow up
measure: Caregiver--Generalized anxiety disorder (GAD-7)
timeFrame: Baseline
measure: Caregiver--Generalized anxiety disorder (GAD-7)
timeFrame: 3 Month Follow up
measure: Caregiver--Generalized anxiety disorder (GAD-7)
timeFrame: 6 Month Follow up
measure: Caregiver--Generalized anxiety disorder (GAD-7)
timeFrame: 9 Month Follow up
measure: Caregiver--Generalized anxiety disorder (GAD-7)
timeFrame: 12 Month Follow up
measure: Patient--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: Baseline
measure: Patient--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 3 Month Follow up
measure: Patient--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 6 Month Follow up
measure: Patient--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 9 Month Follow up
measure: Patient--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 12 Month Follow up
measure: Caregiver--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: Baseline
measure: Caregiver--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 3 Month Follow up
measure: Caregiver--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 6 Month Follow up
measure: Caregiver--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 9 Month Follow up
measure: Caregiver--Integrated Palliative care Outcome Scale (IPOS)
timeFrame: 12 Month Follow up
measure: Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: Baseline
measure: Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 3 Month Follow up
measure: Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 6 Month Follow up
measure: Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 9 Month Follow up
measure: Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 12 Month Follow up
measure: Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: Baseline
measure: Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 3 Month Follow up
measure: Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 6 Month Follow up
measure: Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 9 Month Follow up
measure: Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
timeFrame: 12 Month Follow up
measure: The Zarit Burden Interview (ZBI-12)
timeFrame: Baseline
measure: The Zarit Burden Interview (ZBI-12)
timeFrame: 3 Month Follow up
measure: The Zarit Burden Interview (ZBI-12)
timeFrame: 6 Month Follow up
measure: The Zarit Burden Interview (ZBI-12)
timeFrame: 9 Month Follow up
measure: The Zarit Burden Interview (ZBI-12)
timeFrame: 12 Month Follow up
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: West Virginia University School of Nursing
name: Ubolrat Piamjariyakul
role: PRINCIPAL_INVESTIGATOR
References: