Nurse-Led Phone Support for Heart Failure

(CARE-HF Trial)

Recruiting at 3 trial locations

Overseen By Lucinda J Graven, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Cognitive dysfunction

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Care-HF, Telephone-Based Problem-Solving Intervention for heart failure?

Research shows that nurse-led telephone support for heart failure patients can reduce the risk of death and improve patient outcomes, especially in areas with limited healthcare access. This approach helps manage heart failure by providing ongoing support and education after hospital discharge. ^{1 2 3 4 5}

Is nurse-led phone support for heart failure safe for humans?

The studies reviewed do not report any specific safety concerns related to nurse-led phone support for heart failure patients, suggesting it is generally safe for human use. ^{2 3 6 7 8}

How is the Nurse-Led Phone Support for Heart Failure treatment different from other treatments?

This treatment is unique because it involves nurse-led phone support, which combines education and problem-solving over the phone to help manage heart failure, unlike traditional treatments that may not include this level of remote, personalized support. ^{1 2 5 6 9}

Research Team

Lucinda J Graven, PhD

Principal Investigator

Florida State University College of Nursing

Eligibility Criteria

This trial is for US Veterans aged 18 or older who have been diagnosed with heart failure, regardless of the type. Participants must be able to read, speak, and understand English and have reliable telephone access. Those with a history of cognitive dysfunction cannot join.

Inclusion Criteria

You are a veteran of the United States military.

I have been diagnosed with heart failure.

Able to read, speak, and understand English

Exclusion Criteria

You have a history of problems with memory or thinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Participants complete baseline data collection including various surveys and assessments

1 week

1 visit (telephone)

Treatment

Participants engage in a 12-week telehealth program with 8 telephone sessions led by a registered nurse

12 weeks

8 visits (telephone)

Follow-up

Follow-up data collection to examine sustainability of intervention effect at 3, 6, 12, and 18 months post-intervention

18 months

4 visits (telephone)

Treatment Details

Interventions

• Care-HF

Trial Overview The study tests a tailored telehealth program called Care-HF designed for veterans with heart failure. It involves working with a nurse over the phone for 12 weeks, including eight sessions aimed at improving physical and mental health.

Participant Groups

Group I: CARE-HF Experimental Treatment 1 Intervention

The problem-solving intervention will be led by a registered nurse. Participants will receive a program manual containing examples of common HF-related problems experienced by heart failure patients and suggested management strategies, with some strategies tailored to the rural sociocultural context. The nurse will lead participants in a card sorting task intended to help participants prioritize current HF-related problems and will guide participants in developing management strategies for the highest priority problem(s). Participants will utilize these strategies until the next session at which time the nurse will guide participants in evaluating the effectiveness of chosen strategies. The iterative process then begins again. Participants will receive 7 follow-up telephone sessions with the nurse. In the intervention, the nurse will focus on problems related to self-care, disease management, mental health, and quality of life, including those specific to the rural population.

Care-HF is already approved in United States for the following indications:

Approved in United States as Care-HF for:

• Heart Failure

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

US Department of Veterans Affairs

Collaborator

Trials

881

Recruited

502,000+

Findings from Research

A randomized clinical trial involving 111 heart failure patients showed that both in-hospital education and follow-up telephone monitoring improved patients' understanding of heart failure and self-care knowledge after three months.

However, the addition of telephone contact after discharge did not lead to significant differences in emergency room visits, rehospitalizations, or deaths compared to patients who only received in-hospital education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. Domingues, FB., Clausell, N., Aliti, GB., et al.[2022]

Nurses at a heart failure clinic dedicated 24% of their working hours to conducting 1914 telephone visits in one year, highlighting the significant role of telephone management in patient care.

During these calls, nurses changed medication doses 583 times and ordered diagnostic tests 207 times, demonstrating the critical interventions they provide to manage heart failure effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nature of telephone nursing interventions in a heart failure clinic setting. Staples, P., Earle, W.[2018]

A telephone support strategy, involving an interactive tool and follow-up by cardiac nurses, significantly reduced hospitalizations for any cause and combined death or hospitalization in rural Australians with heart failure, compared to usual care.

While the primary endpoint (Packer clinical composite score) showed no significant difference between the groups, the intervention group had fewer hospitalizations, suggesting that telephone support can improve clinical outcomes for heart failure patients in areas with limited healthcare access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone support to rural and remote patients with heart failure: the Chronic Heart Failure Assessment by Telephone (CHAT) study. Krum, H., Forbes, A., Yallop, J., et al.[2022]

Nurse-led Family Health Conversations (FamHCs) conducted by telephone improved relationships between nurses and families, as well as within the families themselves, indicating a positive impact on family support in heart failure care.

The study found that while telephone FamHCs were feasible and beneficial, nurses preferred shorter sessions and face-to-face interactions to enhance nonverbal communication, suggesting that video telephony could be a valuable alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Health Conversations Conducted by Telephone in Heart Failure Nursing Care: A Feasibility Study. Gusdal, AK., Josefsson, K., Adolfsson, ET., et al.[2021]

Nurse-led follow-up care for heart failure patients after hospital discharge significantly lowers the risk of mortality, highlighting the importance of ongoing support in managing this condition.

This review of case management interventions indicates that structured follow-up by nurses can improve patient outcomes and potentially enhance the quality of care for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse support is most effective follow-up for heart failure patients. [2019]

The implementation of nurse-led heart failure clinics in primary care significantly reduced hospital admissions related to heart failure by 27%, as well as emergency room visits and hospital days, indicating improved management of the condition.

Patients receiving care at these clinics reported higher satisfaction and better adherence to evidence-based treatment guidelines, suggesting that these clinics provide effective and person-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing nurse-led heart failure clinics in Swedish primary care settings. Liljeroos, M., Strömberg, A.[2019]

A review of eight randomized controlled trials found that mobile phone-based interventions, particularly voice call interventions, significantly reduced the length of hospital stays for heart failure patients.

However, these interventions did not show significant effects on all-cause mortality, readmission rates, emergency department visits, or quality of life, indicating that while they may help with hospital stay duration, their overall impact on health outcomes remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Phone-Based Interventions for Improving Health Outcomes in Patients with Chronic Heart Failure: A Systematic Review and Meta-Analysis. Son, YJ., Lee, Y., Lee, HJ.[2020]

The study involved 20 heart failure patients who were randomly assigned to receive either an advanced-practice-nurse-led telephone intervention or usual care, showing that the intervention significantly improved self-care behaviors and reduced hospital readmissions.

The results suggest that implementing an advanced-practice-nurse-led telephone intervention could be an effective strategy to enhance the quality of care for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an advanced practice nurse led telephone intervention on outcomes of patients with heart failure. Brandon, AF., Schuessler, JB., Ellison, KJ., et al.[2019]

The implementation of 'The Weak Heart' educational model significantly improved heart failure knowledge and self-care behaviors among 231 patients hospitalized with acute decompensated heart failure, as evidenced by substantial increases in test scores and self-care behavior assessments after 3 months.

A high percentage of participants (84%) followed up with their primary care physician and 79% with a cardiologist post-discharge, indicating that the educational program not only enhanced knowledge but also encouraged adherence to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A quasi-experimental study examining a nurse-led educational program to improve disease knowledge and self-care for patients with acute decompensated heart failure with reduced ejection fraction. Kolasa, J., Frączek-Jucha, M., Grabowski, M., et al.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Education and telephone monitoring by nurses of patients with heart failure: randomized clinical trial. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

The nature of telephone nursing interventions in a heart failure clinic setting. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Telephone support to rural and remote patients with heart failure: the Chronic Heart Failure Assessment by Telephone (CHAT) study. [2022]

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

Family Health Conversations Conducted by Telephone in Heart Failure Nursing Care: A Feasibility Study. [2021]

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

Nurse support is most effective follow-up for heart failure patients. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Introducing nurse-led heart failure clinics in Swedish primary care settings. [2019]

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

Effectiveness of Mobile Phone-Based Interventions for Improving Health Outcomes in Patients with Chronic Heart Failure: A Systematic Review and Meta-Analysis. [2020]

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

The effects of an advanced practice nurse led telephone intervention on outcomes of patients with heart failure. [2019]

9. Poland pubmed.ncbi.nlm.nih.gov

A quasi-experimental study examining a nurse-led educational program to improve disease knowledge and self-care for patients with acute decompensated heart failure with reduced ejection fraction. [2022]