Heart Failure NYHA Class IIINCT06791850
Sustaining Home Heart Failure Palliative Care in Rural Appalachia
A study testing HF-FamPALhomeCARE in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- HF-FamPALhomeCARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University Hospital
Morgantown, West Virginia, 26506
Stephanie Young, MS, sayers1@hsc.wvu.edu
About this study
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).
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.
Read the 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.
- Being tested
- HF-FamPALhomeCARE
- Keywords
- advanced heart failure, home palliative care, family caregiver, rural Appalachia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF-FamPALhomeCAREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HF-FamPALhomeCARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Month Follow up
Secondary outcomes (45)
Patient--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Baseline
Patient--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 3 Month Follow up
Patient--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 6 Month Follow up
Patient--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 9 Month Follow up
Patient--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 12 Month Follow up
Caregiver--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Baseline
Caregiver--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 3 Month Follow up
Caregiver--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 6 Month Follow up
Caregiver--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 9 Month Follow up
Caregiver--Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: 12 Month Follow up
Patient--Generalized anxiety disorder (GAD-7)
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.
Measured: Baseline
Patient--Generalized anxiety disorder (GAD-7)
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.
Measured: 3 Month Follow up
Patient--Generalized anxiety disorder (GAD-7)
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.
Measured: 6 Month Follow up
Patient--Generalized anxiety disorder (GAD-7)
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.
Measured: 9 Month Follow up
Patient--Generalized anxiety disorder (GAD-7)
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.
Measured: 12 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
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.
Measured: Baseline
Caregiver--Generalized anxiety disorder (GAD-7)
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.
Measured: 3 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
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.
Measured: 6 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
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.
Measured: 9 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
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.
Measured: 12 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: Baseline
Patient--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 3 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 6 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 9 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 12 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: Baseline
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 3 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 6 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 9 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
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.
Measured: 12 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: Baseline
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 3 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 6 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 9 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 12 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: Baseline
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 3 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 6 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 9 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
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.
Measured: 12 Month Follow up
The Zarit Burden Interview (ZBI-12)
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.
Measured: Baseline
The Zarit Burden Interview (ZBI-12)
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.
Measured: 3 Month Follow up
The Zarit Burden Interview (ZBI-12)
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.
Measured: 6 Month Follow up
The Zarit Burden Interview (ZBI-12)
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.
Measured: 9 Month Follow up
The Zarit Burden Interview (ZBI-12)
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.
Measured: 12 Month Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIIStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Ubolrat Piamjariyakul, West Virginia University
- Investigators
- Ubolrat Piamjariyakul, Principal investigator, West Virginia University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791850
- Sponsor's protocol ID
- 2408021376
- Other IDs
- R01NR021630
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 40055735
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06791850
- Acronym / sponsor ID
- 2408021376
- Keywords
- advanced heart failure, home palliative care, family caregiver, rural Appalachia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: HF-FamPALhomeCAREHF-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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HF-FamPALhomeCAREParticipants 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. | Behavioural | HF-FamPALhomeCARE |
Primary outcome
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'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: 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.
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: 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.
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.
45 secondary outcomes
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
Patient--Generalized anxiety disorder (GAD-7)
Time frame: 6 Month Follow up
Patient--Generalized anxiety disorder (GAD-7)
Time frame: 9 Month Follow up
Patient--Generalized anxiety disorder (GAD-7)
Time frame: 12 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
Time frame: Baseline
Caregiver--Generalized anxiety disorder (GAD-7)
Time frame: 3 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
Time frame: 6 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
Time frame: 9 Month Follow up
Caregiver--Generalized anxiety disorder (GAD-7)
Time frame: 12 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
Time frame: Baseline
Patient--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 3 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 6 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 9 Month Follow up
Patient--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 12 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
Time frame: Baseline
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 3 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 6 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 9 Month Follow up
Caregiver--Integrated Palliative care Outcome Scale (IPOS)
Time frame: 12 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: Baseline
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 3 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 6 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 9 Month Follow up
Patient--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 12 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: Baseline
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 3 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 6 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 9 Month Follow up
Caregiver--Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being 12 Item Scale (FACIT-12)
Time frame: 12 Month Follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Derived from this study: PubMed 40055735Piamjariyakul 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ubolrat Piamjariyakul principal investigator
West Virginia University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HF-FamPALhomeCARE in people with Heart Failure NYHA Class III and Heart Failure NYHA Class IV, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ubolrat Piamjariyakul (304.293.6729, ubolrat.piamjariyakul@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.