Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial (RCT).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- West Virginia University
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Masking Description
Care provider and outcome assessor including data collectors will be blinded to group assignment.
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control
Participants in control group receive standard care which is routine HF instruction at primary providers or specialist's clinic appointments.
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.
Intervention: HF-FamPALhomeCARE (Behavioral)
Outcomes
Primary Outcomes
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame: Baseline
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's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame: 3 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's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame: 6 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's Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time Frame: 9 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
Time Frame: Baseline
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.
Patient--World Health Organization Quality of life Questionnaire
Time Frame: 3 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.
Patient--World Health Organization Quality of life Questionnaire
Time Frame: 6 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.
Patient--World Health Organization Quality of life Questionnaire
Time Frame: 9 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
Time Frame: Baseline
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
Time Frame: 3 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
Time Frame: 6 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
Time Frame: 9 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 Outcomes
- Patient--Patient Health Questionnaire-9 (PHQ-9)(12 Month Follow up)
- Caregiver--Patient Health Questionnaire-9 (PHQ-9)(12 Month Follow up)
- Patient--Generalized anxiety disorder (GAD-7)(12 Month Follow up)
- Caregiver--Generalized anxiety disorder (GAD-7)(12 Month Follow up)
- Patient--Integrated Palliative care Outcome Scale (IPOS)(12 Month Follow up)
- Caregiver--Integrated Palliative care Outcome Scale (IPOS)(12 Month Follow up)
- Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(12 Month Follow up)
- Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(12 Month Follow up)
- The Zarit Burden Interview (ZBI-12)(12 Month Follow up)
- 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)
- Caregiver--Patient Health Questionnaire-9 (PHQ-9)(Baseline)
- Caregiver--Patient Health Questionnaire-9 (PHQ-9)(3 Month Follow up)
- Caregiver--Patient Health Questionnaire-9 (PHQ-9)(6 Month Follow up)
- Caregiver--Patient Health Questionnaire-9 (PHQ-9)(9 Month Follow up)
- Patient--Generalized anxiety disorder (GAD-7)(Baseline)
- Patient--Generalized anxiety disorder (GAD-7)(3 Month Follow up)
- Patient--Generalized anxiety disorder (GAD-7)(6 Month Follow up)
- Patient--Generalized anxiety disorder (GAD-7)(9 Month Follow up)
- Caregiver--Generalized anxiety disorder (GAD-7)(Baseline)
- Caregiver--Generalized anxiety disorder (GAD-7)(3 Month Follow up)
- Caregiver--Generalized anxiety disorder (GAD-7)(6 Month Follow up)
- Caregiver--Generalized anxiety disorder (GAD-7)(9 Month Follow up)
- Patient--Integrated Palliative care Outcome Scale (IPOS)(Baseline)
- Patient--Integrated Palliative care Outcome Scale (IPOS)(3 Month Follow up)
- Patient--Integrated Palliative care Outcome Scale (IPOS)(6 Month Follow up)
- Patient--Integrated Palliative care Outcome Scale (IPOS)(9 Month Follow up)
- Caregiver--Integrated Palliative care Outcome Scale (IPOS)(Baseline)
- Caregiver--Integrated Palliative care Outcome Scale (IPOS)(3 Month Follow up)
- Caregiver--Integrated Palliative care Outcome Scale (IPOS)(6 Month Follow up)
- Caregiver--Integrated Palliative care Outcome Scale (IPOS)(9 Month Follow up)
- Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(Baseline)
- Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(3 Month Follow up)
- Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(6 Month Follow up)
- Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(9 Month Follow up)
- Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(Baseline)
- Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(3 Month Follow up)
- The Zarit Burden Interview (ZBI-12)(9 Month Follow up)
- Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(6 Month Follow up)
- Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)(9 Month Follow up)
- The Zarit Burden Interview (ZBI-12)(Baseline)
- The Zarit Burden Interview (ZBI-12)(3 Month Follow up)
- The Zarit Burden Interview (ZBI-12)(6 Month Follow up)
Investigators
Ubolrat Piamjariyakul
Associate Dean for Research and Scholarship
West Virginia University