Clinical trial NCT04153890: Family Palliative and End-of-Life Care for Advanced Heart Failure
Official title: Coaching End-of-Life Palliative Care for End-Stage Heart Failure Patients and Their Family Caregivers in Rural Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class III
Heart Failure NYHA Class IV
Keywords: advanced heart failure, breathlessness, supportive care
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-11-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a low-risk randomized control trial design to test the implementation of the FamPALcare intervention with advanced HF patients and their primary family caregivers.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Alert and consent to participate
2. Able to read and understand English
3. Advanced HF (NYHA III or IV), diagnosed by physician

Exclusion Criteria:

1. Already received or are on a waiting list for a heart transplant or left ventricular assist device (LVAD)
2. Diagnosed with a terminal illness or dementia, such as Alzheimer's disease

Primary outcomes:
measure: Patient Heart Failure Health Status (KCCQ)- Baseline
timeFrame: Baseline
measure: Patient Heart Failure Health Status (KCCQ) -3 Month
timeFrame: 3 Month
measure: Patient Heart Failure Health Status (KCCQ)- 6 Month
timeFrame: 6 Month
measure: Patient Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
timeFrame: Baseline
measure: Patient Mental Health - Patient Health Questionnaire (PHQ4)- 3 Month
timeFrame: 3 Month
measure: Patient Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
timeFrame: 6 Month
measure: Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- Baseline
timeFrame: Baseline
measure: Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 3 Month
timeFrame: 3 Month
measure: Caregiver Mental Health - Patient Health Questionnaire (PHQ-4)- 6 Month
timeFrame: 6 Month
measure: Caregiver Quality of Life - SF12V2 Health Survey- Baseline (MCS-12)
timeFrame: Baseline
measure: Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (MCS-12)
timeFrame: 3 Month
measure: Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (MCS-12)
timeFrame: 6 Months
measure: Caregiver Quality of Life - SF12V2 Health Survey- Baseline (PCS-12)
timeFrame: Baseline
measure: Caregiver Quality of Life - SF12v2 Health Survey- 3 Month (PCS-12)
timeFrame: 3 Month
measure: Caregiver Quality of Life - SF12v2 Health Survey- 6 Month (PCS-12)
timeFrame: 6 Months
measure: Caregiver Burden (ZBI-12)- Baseline
timeFrame: Baseline
measure: Caregiver Burden (ZBI-12)- 3 Month
timeFrame: 3 Month
measure: Caregiver Burden (ZBI-12)- 6 Month
timeFrame: 6 Month
Secondary outcomes:
measure: FamPALcare Helpfulness Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: West Virginia University, School of Nursing
name: Ubolrat Piamjariyakul, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Piamjariyakul 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.
citation: Piamjariyakul 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.
citation: Piamjariyakul 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.