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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the HF-FamPALhomeCARE treatment for heart failure?

Research shows that heart failure management programs and pharmacist care can improve outcomes and quality of life for heart failure patients, suggesting that structured care approaches like HF-FamPALhomeCARE may also be beneficial. ^{1 2 3 4 5}

What safety data exists for HF-FamPALhomeCARE for Heart Failure?

There is no specific safety data available for HF-FamPALhomeCARE for Heart Failure in the provided research articles. ^{6 7 8 9 10}

Research Team

Ubolrat Piamjariyakul

Principal Investigator

West Virginia University School of Nursing

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The benefits of using a heart failure management programme in Swedish primary healthcare. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Factors associated with health-related quality of life in elderly Korean patients with heart failure. [2022]

3. Poland pubmed.ncbi.nlm.nih.gov

Quality of care of hospitalised patients with heart failure in Poland in 2013: results of the second nationwide survey. [2017]

4. Canada pubmed.ncbi.nlm.nih.gov

Approach to advanced heart failure at the end of life. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The evidence for pharmacist care in outpatients with heart failure: a systematic review and meta-analysis. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

How safe is hospital-in-the-home care? [2020]

9. England pubmed.ncbi.nlm.nih.gov

Associations between patient factors and adverse events in the home care setting: a secondary data analysis of two canadian adverse event studies. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Adverse drug events and medication problems in "Hospital at Home" patients. [2019]