Heart Failure NYHA Class IIINCT04153890
Family Palliative and End-of-Life Care for Advanced Heart Failure
A study testing FamPALcare 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
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- FamPALcare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alert and consent to participate
- Able to read and understand English
- Advanced HF (NYHA III or IV), diagnosed by physician
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.
United States1 site
West Virginia University Hospital
Morgantown, West Virginia, 26506
About this study
Official title: Coaching End-of-Life Palliative Care for End-Stage Heart Failure Patients and Their Family Caregivers in Rural Appalachia
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.
Read the detailed description
Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers especially during severe symptoms in the long-lasting end stage. Advanced HF was defined by American Heart Association (AHA) as "the presence of progressive and/or persistent severe signs and symptoms of HF despite optimized medical, surgical, and device therapy." When patients and family members are not prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options, they experience depression, fear of painful death, home care burden, and medical expenses from anxiously seeking aggressive but futile care. Notably, West Virginia (WV) has the highest HF death in the U.S. at 32.6 per 100,000 population, where 14% of those over 65 years have HF. WV is in the large Appalachian region, which stretches across eastern North America with 25.6 million people and contains a vast number of disadvantaged rural communities. National Institutes of Health has designated Appalachia as a high priority for research as residents experience extreme health and poverty inequities and limited access to healthcare. Furthermore, home EOLPC is lacking across this disadvantaged rural area. Thus, there is a need to investigate the new family intervention (FamPALcare), where nurses coach family-managed advanced HF care at home in Appalachia.
This study addresses the National Institutes of Health Academic Research Enhancement Award (AREA) priorities for conducting a low risk clinical trials to provide a foundation to advance scientific EOLPC knowledge and testing of our intervention efficacy in larger clinical trials. Additionally, effective EOLPC interventions are priorities of palliative care professionals and palliative care needs must be addressed with vulnerable and advanced HF patients and their families. This study also addresses the priority problem of the lack information for families providing advanced HF home care and preventing unwanted and unwarranted rehospitalizations at the advanced stage of HF.
This study uses a randomized controlled trial (RCT) design stratified by gender (male vs female) to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care control group outcomes (N=72). Specific aims are to: (1) Test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF in rural WV using a small randomized controlled trial (RCT) and (2) Assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials.
The control patients receive standard care given through the West Virginia University hospital and outpatient clinics, prescribed by the patient's cardiologist. The FamPALcare intervention group will receive standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions. Data will be collected from all patients and caregivers independently at baseline, 3 months, and 6 months.
- Being tested
- FamPALcare
- Keywords
- advanced heart failure, breathlessness, supportive care
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamPALcareBehavioural
Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care.
| Study group | Role | What they receive |
|---|---|---|
| FamPALcare | Experimental | FamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. Receives: Behavioral: FamPALcare |
| Standard Care | No intervention | The standard care group will receive routine HF care and instruction at university hospital or at clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Heart Failure Health Status (KCCQ)- Baseline
The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.
Measured: Baseline
Patient Heart Failure Health Status (KCCQ) -3 Month
The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.
Measured: 3 Month
Patient Heart Failure Health Status (KCCQ)- 6 Month
The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.
Measured: 6 Month
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Measured: Baseline
Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month
Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Measured: 3 Month
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Measured: 6 Month
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Measured: Baseline
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month
Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Measured: 3 Month
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Measured: 6 Month
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12)
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Measured: Baseline
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12)
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Measured: 3 Month
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12)
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for both the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Measured: 6 Months
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12)
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Measured: Baseline
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12)
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Measured: 3 Month
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12)
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Measured: 6 Months
Caregiver Burden (ZBI-12)- Baseline
The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
Measured: Baseline
Caregiver Burden (ZBI-12)- 3 Month
The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
Measured: 3 Month
Caregiver Burden (ZBI-12)- 6 Month
The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
Measured: 6 Month
Secondary outcomes (1)
FamPALcare Helpfulness Scale
This scale was completed voluntarily by participants that received the intervention (ARM Title: FamPALcare. The FamPALcare helpfulness scale is an 11-item Likert-type scale used to measure the perceived helpfulness of the FamPALcare intervention. Participants rate each item on a scale from 1 (not helpful) to 5 (very helpful). This scale is used to assess the effectiveness of the intervention in improving outcomes for patients with heart failure and their caregivers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start13 Jan 2020
- Primary completion31 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 implementation of the FamPALcare intervention with advanced HF patients and their primary family caregivers.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
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, PhD, RN, Principal investigator, West Virginia University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153890
- Sponsor's protocol ID
- 1709754988
- Other IDs
- 1R15NR018547-01
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2019
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study plans to share data in aggregate and as overall study results.
Publications
Piamjariyakul U, Petitte T, Smothers A, Wen S, Morrissey E, Young S, Sokos G, Moss AH, Smith CE. Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial. BMC Palliat Care. 2019 Dec 29;18(1):119. doi: 10.1186/s12904-019-0500-z.
PubMed 31884945Piamjariyakul U, Keener TA, Smothers A, Young S, Shafique S, McDill S, Keech K, Petitte T, Pacheco C. Mentoring Undergraduate Nursing Students in Palliative Home Care Research. Teach Learn Nurs. 2021 Oct;16(4):423-428. doi: 10.1016/j.teln.2021.05.001. Epub 2021 Jun 5. No abstract available.
PubMed 34720774Piamjariyakul U, Shafique S, Friend DL, Adams KA, Sanghuachang W, Petitte TM, Young S. The development and evaluation of a short-term international student research and educational program. Int J Nurs Sci. 2023 Dec 6;11(1):83-90. doi: 10.1016/j.ijnss.2023.12.001. eCollection 2024 Jan.
PubMed 38352285Piamjariyakul U, Smothers A, Wang K, Shafique S, Wen S, Petitte T, Young S, Sokos G, Smith CE. Palliative care for patients with heart failure and family caregivers in rural Appalachia: a randomized controlled trial. BMC Palliat Care. 2024 Aug 3;23(1):199. doi: 10.1186/s12904-024-01531-2.
PubMed 39097733
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching End-of-Life Palliative Care for End-Stage Heart Failure Patients and Their Family Caregivers in Rural Appalachia
- ClinicalTrials.gov ID
- NCT04153890
- Acronym / sponsor ID
- 1709754988
- Keywords
- advanced heart failure, breathlessness, supportive care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Posted 19 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for advanced heart failure at 6 months follow up.
Detailed description
Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers especially during severe symptoms in the long-lasting end stage. Advanced HF was defined by American Heart Association (AHA) as "the presence of progressive and/or persistent severe signs and symptoms of HF despite optimized medical, surgical, and device therapy." When patients and family members are not prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options, they experience depression, fear of painful death, home care burden, and medical expenses from anxiously seeking aggressive but futile care. Notably, West Virginia (WV) has the highest HF death in the U.S. at 32.6 per 100,000 population, where 14% of those over 65 years have HF. WV is in the large Appalachian region, which stretches across eastern North America with 25.6 million people and contains a vast number of disadvantaged rural communities. National Institutes of Health has designated Appalachia as a high priority for research as residents experience extreme health and poverty inequities and limited access to healthcare. Furthermore, home EOLPC is lacking across this disadvantaged rural area. Thus, there is a need to investigate the new family intervention (FamPALcare), where nurses coach family-managed advanced HF care at home in Appalachia.
This study addresses the National Institutes of Health Academic Research Enhancement Award (AREA) priorities for conducting a low risk clinical trials to provide a foundation to advance scientific EOLPC knowledge and testing of our intervention efficacy in larger clinical trials. Additionally, effective EOLPC interventions are priorities of palliative care professionals and palliative care needs must be addressed with vulnerable and advanced HF patients and their families. This study also addresses the priority problem of the lack information for families providing advanced HF home care and preventing unwanted and unwarranted rehospitalizations at the advanced stage of HF.
This study uses a randomized controlled trial (RCT) design stratified by gender (male vs female) to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care control group outcomes (N=72). Specific aims are to: (1) Test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF in rural WV using a small randomized controlled trial (RCT) and (2) Assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials.
The control patients receive standard care given through the West Virginia University hospital and outpatient clinics, prescribed by the patient's cardiologist. The FamPALcare intervention group will receive standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions. Data will be collected from all patients and caregivers independently at baseline, 3 months, and 6 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 implementation of the FamPALcare intervention with advanced HF patients and their primary family caregivers.
| Arm | Type | Receives |
|---|---|---|
| FamPALcare | Experimental | Behavioral: FamPALcareFamPALcare: Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. |
| Standard Care | No intervention | –The standard care group will receive routine HF care and instruction at university hospital or at clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Alert and consent to participate
- Able to read and understand English
- Advanced HF (NYHA III or IV), diagnosed by physician
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 |
|---|---|---|
| FamPALcareIntervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. | Behavioural | FamPALcare |
Primary outcome
Patient Heart Failure Health Status (KCCQ)- Baseline
Time frame: Baseline
The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.
Patient Heart Failure Health Status (KCCQ) -3 Month
Time frame: 3 Month
The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.
Patient Heart Failure Health Status (KCCQ)- 6 Month
Time frame: 6 Month
The patients Heart Failure Health Status was measured by administering the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 12-item Likert scale (range 0-4). Total scores are calculated in a range of 0-100, with the higher score indicating better Heart Failure Health Status.
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
Time frame: Baseline
Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month
Time frame: 3 Month
Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
Time frame: 6 Month
Patient-reported mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
Time frame: Baseline
Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month
Time frame: 3 Month
Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
Time frame: 6 Month
Caregiver mental health measured by Patient Health Questionnaire (PHQ-4) of 4 questions. Each question is scored on a scale from 0 to 3, based on how often the respondent has been bothered by the problem 0 is not at all and 3 is nearly every day. The total score ranges from 0 to 12. The higher the score indicates a worse mental health status.
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12)
Time frame: Baseline
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12)
Time frame: 3 Month
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12)
Time frame: 6 Months
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for both the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12)
Time frame: Baseline
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12)
Time frame: 3 Month
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12)
Time frame: 6 Months
The SF-12v2 Health Survey is a multipurpose short-form questionnaire with only 12 questions with two summary scores, the SF-12 Physical Component Summary (PCS-12) and the SF-12 Mental Component Summary (MCS-12). The scoring range for the PCS-12 and MCS-12 is 0 to 100, with a lower score indicating a poorer level of Caregiver quality of life.
Caregiver Burden (ZBI-12)- Baseline
Time frame: Baseline
The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
Caregiver Burden (ZBI-12)- 3 Month
Time frame: 3 Month
The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
Caregiver Burden (ZBI-12)- 6 Month
Time frame: 6 Month
The Zarit Burden Interview-12 (ZBI-12) consists of 12 items that measure the emotional, physical, and social impact of caregiving. There are 12 questions and each question is rated on a 5-point scale from 0 (never) to 4 (nearly always). The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
1 secondary outcome
FamPALcare Helpfulness Scale
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31884945Piamjariyakul U, Petitte T, Smothers A, Wen S, Morrissey E, Young S, Sokos G, Moss AH, Smith CE. Study protocol of coaching end-of-life palliative care for advanced heart failure patients and their family caregivers in rural appalachia: a randomized controlled trial. BMC Palliat Care. 2019 Dec 29;18(1):119. doi: 10.1186/s12904-019-0500-z.
- Background: PubMed 34720774Piamjariyakul U, Keener TA, Smothers A, Young S, Shafique S, McDill S, Keech K, Petitte T, Pacheco C. Mentoring Undergraduate Nursing Students in Palliative Home Care Research. Teach Learn Nurs. 2021 Oct;16(4):423-428. doi: 10.1016/j.teln.2021.05.001. Epub 2021 Jun 5. No abstract available.
- Background: PubMed 38352285Piamjariyakul U, Shafique S, Friend DL, Adams KA, Sanghuachang W, Petitte TM, Young S. The development and evaluation of a short-term international student research and educational program. Int J Nurs Sci. 2023 Dec 6;11(1):83-90. doi: 10.1016/j.ijnss.2023.12.001. eCollection 2024 Jan.
- Results publication: PubMed 39097733Piamjariyakul U, Smothers A, Wang K, Shafique S, Wen S, Petitte T, Young S, Sokos G, Smith CE. Palliative care for patients with heart failure and family caregivers in rural Appalachia: a randomized controlled trial. BMC Palliat Care. 2024 Aug 3;23(1):199. doi: 10.1186/s12904-024-01531-2.
- Individual participant dataSharing planned: No. The study plans to share data in aggregate and as overall study results.
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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. This study is not recruiting at the moment.
Ubolrat Piamjariyakul, PhD, RN 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 FamPALcare 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 3 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: finished, as of the sponsor's last update on 19 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Heart Failure Health Status (KCCQ)- Baseline (time frame: Baseline). The study lists 18 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 NCT04153890, which also lists 4 linked publications.
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 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.