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Trial record 41 of 887 for:    Recruiting, Not yet recruiting, Available Studies | Congestive heart failure

Family Palliative and End-of-Life Care for Advanced Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04153890
Recruitment Status : Not yet recruiting
First Posted : November 6, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Ubolrat Piamjariyakul, West Virginia University

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.

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class III Heart Failure NYHA Class IV Behavioral: FamPALcare Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Care provider and outcome assessor including data collectors will be blinded to group assignment.
Primary Purpose: Supportive Care
Official Title: Coaching End-of-Life Palliative Care for End-Stage Heart Failure Patients and Their Family Caregivers in Rural Appalachia
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FamPALcare
Standard Care plus FamPALcare
Behavioral: FamPALcare

Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. FamPALcare intervention will be delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions.

The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. All patients can be referred for supportive care and heart failure care per national HF guidelines.


No Intervention: Standard Care
The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. All patients can be referred for supportive care and heart failure care per national HF guidelines.



Primary Outcome Measures :
  1. Patient HF health status [ Time Frame: Through 6 months post baseline ]
    Change from baseline in patient-reported HF health status measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) over 6 months. KCCQ is a 12-item Likert scale (range 0-4). Scores will be rescaled to 0-100, higher score indicates better HF health status.

  2. Patient mental health - depression & anxiety [ Time Frame: Through 6 months post baseline ]
    Change from baseline in patient-reported mental health measured by -item Likert Patient Health Questionnaire (PHQ-4) scale (range 0-3), higher score indicates poor mental health status.

  3. Patient signed advance directive [ Time Frame: Through 6 months post baseline ]
    increased numbers of signed advance directives

  4. Caregiver mental health - depression & anxiety [ Time Frame: Through 6 months post baseline ]
    Change from baseline in caregiver reported mental health measured by -item Likert Patient Health Questionnaire (PHQ-4) scale (range 0-3), higher score indicates poor mental health status.

  5. Caregiver quality of life - physical and mental health [ Time Frame: Through 6 months post baseline ]
    Change from baseline in caregiver reported physical and mental health measured by 12-item Likert SF12V2 Health Survey (PCS and MCS scores). Standardized scores will be calculated. Higher scores indicate better quality of life.

  6. Caregiver burden [ Time Frame: Through 6 months post baseline ]
    Change from baseline in caregiver-reported burden measured by 12-item Likert Short-form Caregiver Burden Interviews(range 0-4), higher score indicates poorer outcomes (more burden).

  7. Patient and caregiver confidence in providing palliative home care for advanced HF [ Time Frame: Through 6 months post baseline ]
    Change from baseline in patient- and caregiver-reported confidence in HF home care measured by 4-item Likert Confidence scale (range 1-4), higher score indicates higher confidence.

  8. Patient and caregiver preparedness in providing palliative home care for advanced HF [ Time Frame: Through 6 months post baseline ]
    Change from baseline in patient - and caregiver-reported preparedness in HF home care measured by 1-item Likert perceived preparedness question (range 0-4), high score indicates better preparedness.


Secondary Outcome Measures :
  1. Evaluate intervention helpfulness (patients and caregivers) [ Time Frame: Completed at 6 months ]
    Evaluate intervention helpfulness by patients and caregiver via 11-item Likert helpfulness scale, high score indicates more helpfulness

  2. Evaluate intervention helpfulness (healthcare professionals) [ Time Frame: Completed at 6 months ]
    Evaluate intervention helpfulness by healthcare professionals via 8-item Likert helpfulness scale, high score indicates more helpfulness

  3. Evaluate healthcare utilizations [ Time Frame: Completed over 6 months ]
    Change from baseline in healthcare utilization (hospitalization, ER visits) via medical record review



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153890


Contacts
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Contact: West Virginia University, School of Nursing 304-293-6729 brocovich@hsc.wvu.edu

Sponsors and Collaborators
West Virginia University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Ubolrat Piamjariyakul, PhD, RN West Virginia University, School of Nursing

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ubolrat Piamjariyakul, Associate Dean for Research and Scholarship, West Virginia University
ClinicalTrials.gov Identifier: NCT04153890    
Other Study ID Numbers: 1709754988
1R15NR018547-01 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The study plans to share data in aggregate and as overall study results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ubolrat Piamjariyakul, West Virginia University:
advanced heart failure, breathlessness, supportive care
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases