HF-FamPALhomeCARE for Heart Failure

Overseen By Stephanie Young

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

Disqualifiers: Heart transplant, LVAD, Terminal illness, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist people with severe heart failure living in rural areas. The focus is on a nurse-led program called HF-FamPALhomeCARE, which combines home visits and phone calls to enhance care and support for patients and their families. Participants will either receive their usual heart failure care or this additional support program. The trial seeks individuals diagnosed with advanced heart failure who can understand and consent to join the study. The researchers aim to determine if this new approach can make managing heart failure at home easier and more effective. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions that could improve the quality of life for heart failure patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the HF-FamPALhomeCARE intervention is safe for heart failure patients?

Research has not yet provided specific safety information for the HF-FamPALhomeCARE treatment. This new approach manages heart failure and provides palliative care at home, particularly in rural areas.

As the treatment is in the "Not Applicable" phase, detailed safety information may not be available. However, the treatment includes home visits and phone calls from nurses, generally considered low-risk. These methods emphasize support and care management rather than medical procedures or new medications.

Participants should consult their healthcare provider to understand what joining the trial might mean for them personally. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HF-FamPALhomeCARE for heart failure because it goes beyond standard care by integrating home-based and remote support. Unlike typical treatments that mainly involve medication and regular clinic visits, this approach includes two home visits and multiple bi-weekly phone calls to provide end-of-life and palliative care guidance directly to the patient's home environment. This comprehensive support system aims to improve patient outcomes and quality of life by offering personalized care and continuous monitoring, potentially reducing hospital readmissions and enhancing patient and family engagement in managing heart failure.

What evidence suggests that HF-FamPALhomeCARE might be an effective treatment for heart failure?

Research shows that HF-FamPALhomeCARE, which participants in this trial may receive, might help people with heart failure manage their condition better at home. Previous studies have found that home-based programs can improve symptoms and reduce hospital visits for these patients. This program includes regular home visits and phone support to assist families in caring for loved ones with heart failure. Early results suggest that such programs can enhance quality of life by providing necessary support and easing caregiving. While more information is needed, this approach builds on successful methods used in similar programs. ^{1 2 3 4 6}

Who Is on the Research Team?

Ubolrat Piamjariyakul

Principal Investigator

West Virginia University School of Nursing

Are You a Good Fit for This Trial?

This trial is for caregivers aged 45-80 and adult patients aged 50-80 with advanced heart failure (NYHA III or IV) in rural Appalachia. Participants must be alert, consent to participate, and understand English. Those already waiting for a heart transplant or LVAD, or diagnosed with terminal illness/dementia like Alzheimer's cannot join.

Inclusion Criteria

I am a caregiver aged between 45 and 80.

Alert and consent to participate

Able to read and understand English

Exclusion Criteria

I am waiting for or have received a heart transplant or LVAD.

I have been diagnosed with a terminal illness or dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the HF-FamPALhomeCARE group receive 2 home visits and 3 bi-weekly telephone calls on HF home EOLPC care

6 weeks

2 home visits, 3 telephone calls

Follow-up

Participants are monitored for health outcomes at 3, 6, 9, and 12 months

12 months

4 follow-up telephone calls

What Are the Treatments Tested in This Trial?

Interventions

• HF-FamPALhomeCARE

Trial Overview The study tests an integrated nurse-led intervention bundle combining family home care management and palliative care for end-stage heart failure patients in rural areas. It involves faith-based nurses and local volunteers to help overcome healthcare access disparities.

How Is the Trial Designed?

Group I: HF-FamPALhomeCARE Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

Participants in control group receive standard care which is routine HF instruction at primary providers or specialist's clinic appointments.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The Family Reporting System (FRS) was developed to allow families of hospitalized children to report adverse events, addressing the limitations of standard clinician-initiated reporting systems that often miss many documented events.

The FRS demonstrated good face validity, excellent usability, and strong clinical utility, indicating it is an effective tool for enhancing patient safety by capturing valuable information from families about potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. Daniels, JP., King, AD., Cochrane, DD., et al.[2022]

A study of 1300 hospitalized heart failure patients in Poland showed improvements in care quality from 2005 to 2013, including better access to echocardiography and increased use of beta-blockers and mineralocorticoid receptor antagonists.

However, there was a notable decrease in the prescription of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), likely due to the aging patient population and a rise in comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of care of hospitalised patients with heart failure in Poland in 2013: results of the second nationwide survey. Fedyk-Łukasik, M., Wizner, B., Opolski, G., et al.[2017]

Pharmacist care significantly improves medication adherence, patient knowledge, and quality of life in outpatients with heart failure, based on a systematic review of 24 randomized controlled trials involving 8029 patients.

While pharmacist interventions did not show statistically significant reductions in all-cause mortality or hospitalizations, they did enhance symptom control and overall quality of life, suggesting that pharmacists play a crucial role in managing complex medication regimens for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. Schumacher, PM., Becker, N., Tsuyuki, RT., et al.[2021]

In a study of 231 patients receiving hospital-in-the-home (HIH) care, the rate of adverse events was low, with only 3.5% experiencing iatrogenic complications, indicating that HIH care is a safe alternative to traditional hospitalization.

The study found that 4.2% of patients required a return to the hospital during their HIH admission, and 2.2% returned within 14 days of discharge, suggesting that while HIH care is generally safe, there are still some risks that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How safe is hospital-in-the-home care? Montalto, M.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11887341/

Study protocol of sustaining home palliative care ... Study protocol of sustaining home palliative care for patients with Heart Failure (HF) and their family caregivers in rural Appalachia: a mixed ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06791850

Sustaining Home Heart Failure Palliative Care in Rural ... Sustaining Home Palliative Care for Patients With Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized ...

3. withpower.com withpower.com/trial/hf-fampalhomecare-for-heart-failure-3a66c

HF-FamPALhomeCARE for Heart Failure What data supports the effectiveness of the HF-FamPALhomeCARE treatment for heart failure? Research shows that heart failure management programs and ...

4. researchgate.net researchgate.net/publication/389659437_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

(PDF) Study protocol of sustaining home palliative care for ... Study protocol of sustaining home palliative care for patients with Heart Failure (HF) and their family caregivers in rural Appalachia: a mixed methods ...

5. researchgate.net researchgate.net/publication/382852220_Palliative_care_for_patients_with_heart_failure_and_family_caregivers_in_rural_Appalachia_a_randomized_controlled_trial

(PDF) Palliative care for patients with heart failure and ... Background Heart failure (HF) is a debilitating disease with worsening symptoms and family caregiving burden. HF affects more than 8 million Americans.

6. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01NR021630&arg_ProgOfficeCode=136

Award Information | HHS TAGGS Sustaining Home Palliative Care for Patients with Heart Failure (HF) and Their Family Caregivers in Rural Appalachia: A Mixed Methods Randomized Clinical Trial ...