Patient Education for Heart Failure

Recruiting at 3 trial locations

Overseen By Sumanth Bandaru, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Baltimore

Disqualifiers: Pregnancy, Advanced organ failure, others

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

Compensation: Varies

Number of Visits: 4

500 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on patient education for heart failure treatment adherence.

What data supports the idea that Patient Education for Heart Failure is an effective treatment?

The available research shows that patient education for heart failure can be effective when it includes ongoing support and monitoring by a team of healthcare professionals. This approach helps patients manage their condition better by reinforcing what they learn and encouraging them to follow their treatment plans. Although the specific components that make education successful are not fully understood, it is clear that education helps patients understand their treatment, which can lead to better health outcomes. ^{1 2 3 4 5}

What safety data exists for patient education in heart failure treatment?

The reviewed literature does not specifically address safety data for patient education in heart failure treatment. The focus is on the effectiveness of educational interventions, their characteristics, and the role of nurses. While patient education is recognized as important for managing heart failure, the studies do not provide detailed safety data or adverse effects related to these educational interventions. ^{1 2 6 7 8}

Is Patient Education a promising treatment for Heart Failure?

Yes, Patient Education is a promising treatment for Heart Failure. It helps patients understand their condition better, encourages self-care, and can reduce hospital visits. Nurses play a key role in providing this education, and using computer-based tools can make learning more effective. ^{1 2 4 9 10}

What is the purpose of this trial?

The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.

Research Team

Anup Agarwal, MD

Principal Investigator

MedStar Health

Eligibility Criteria

This trial is for patients with heart failure where the heart's pumping power is reduced. They should be recently discharged from the hospital and willing to learn about their treatment guidelines at set intervals after discharge.

Inclusion Criteria

I am older than 18 years.

Able to consent for enrollment

My heart's pumping ability is significantly reduced.

Exclusion Criteria

Pregnancy

Patients with Heart failure Collaboratory Score (HFCS) of 9

My condition is too advanced for standard treatments to be effective.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Education

Participants receive initial face-to-face education during hospital admission and an educational flier about GDMT

During hospital stay

1 visit (in-person)

Post-Discharge Education

Intervention group receives additional education via phone at 1, 3, and 5 months post-discharge, including GDMT benefits, side effects, and adherence encouragement

5 months

3 sessions (phone calls)

Follow-up

Participants are monitored for changes in GDMT score and other health outcomes

6 months

Treatment Details

Interventions

• Patient Education

Trial Overview The study tests if teaching patients about their heart failure treatments can help them stick to these plans better. Participants will get special education sessions on this topic 1, 3, and 5 months after leaving the hospital.

Participant Groups

Group I: Intervention Active Control 1 Intervention

Intervention arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. They will get 3 more sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.

Group II: Control Active Control 1 Intervention

Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT.

Who Is Running the Clinical Trial?

Medstar Health Baltimore

Lead Sponsor

Trials

1

Recruited

500+

Findings from Research

Patient education for heart failure management should go beyond just teaching knowledge and skills; it is more effective when combined with ongoing support, symptom monitoring, and behavioral reinforcement from a team of healthcare professionals.

Nurses play a crucial role in improving patient education by developing and testing effective teaching protocols, which can then be standardized and integrated into electronic health records for better chronic care management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education in heart failure. Edwardson, SR.[2007]

A systematic review of 19 studies involving 2686 heart failure patients found that educational interventions, primarily one-on-one sessions led by nurses, can improve patient knowledge, but the effectiveness on health outcomes varies significantly.

Despite some studies showing positive effects, the variability in educational methods and evaluation measures makes it challenging to determine the best approach for patient education in heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational interventions for patients with heart failure: a systematic review of randomized controlled trials. Boyde, M., Turner, C., Thompson, DR., et al.[2022]

In a study of 230 heart failure patients, standard information provided before hospital discharge did not significantly differ in effectiveness from additional education using an interactive CD-ROM, with 52% of the standard group and 49% of the education group reaching the endpoint of readmission or death within 6 months.

Patients who received the interactive education showed improved knowledge about heart failure, suggesting that while the education did not significantly reduce readmission rates, better understanding of the condition may lead to marginally better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive CD-program on 6 months readmission rate in patients with heart failure - a randomised, controlled trial [NCT00311194]. Linné, AB., Liedholm, H.[2018]

A study involving 34 inpatients with congestive heart failure (CHF) found that patients rated information on medication, cardiovascular anatomy, and treatment as the most important to learn, indicating a clear focus on practical care aspects.

The modified CHF Patient Learning Needs Inventory did not enhance differentiation in patients' information needs, suggesting that simpler methods like rank ordering may be sufficient to assess learning needs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning needs of patients with congestive heart failure. Chan, AD., Reid, GJ., Farvolden, P., et al.[2022]

Two new instruments were developed to enhance patient education in heart failure management: the Educational Material Acceptability (EMA) and the Knowledge Acquisition Questionnaire (KAQ), which help assess how well patients understand their treatment.

The EMA showed good internal consistency (0.79), while the KAQ demonstrated moderate internal consistency (0.61) and strong responsiveness (0.75), indicating these tools can effectively measure patient knowledge and the acceptability of educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instruments to measure acceptability of information and acquisition of knowledge in patients with heart failure. Gwadry-Sridhar, F., Guyatt, GH., Arnold, JM., et al.[2019]

Patient education is crucial in heart failure care, as it significantly reduces hospital readmissions, highlighting the importance of effective educational interventions.

Multisession motivational interventions that are repeated over time and include follow-up support yield the best outcomes for heart failure patients, emphasizing the vital role of nurses in delivering this education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educational interventions in patients with heart failure: a review of the literature]. Spatola, CF., Cocchieri, A., De Marinis, MG., et al.[2013]

A qualitative study involving 25 heart failure patients revealed that many experienced delays in diagnosis due to misattribution of symptoms, highlighting the need for better communication and understanding of their condition.

While most patients recognized the importance of self-monitoring and following treatment recommendations, they expressed a desire for more information about their prognosis and advance care planning, indicating a gap in patient education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"They diagnosed bad heart": a qualitative exploration of patients' knowledge about and experiences with heart failure. Rodriguez, KL., Appelt, CJ., Switzer, GE., et al.[2008]

A review of 19 randomized controlled trials on therapeutic patient education for heart failure revealed that while major elements of program descriptions were present, critical information such as patients' educational needs and evaluation methods were often missing.

Improving the precision of program descriptions in future studies could enhance the effectiveness of therapeutic patient education for heart failure patients, suggesting a need for standardized reporting formats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? Albano, MG., Jourdain, P., De Andrade, V., et al.[2014]

Patient education is crucial for heart failure management, helping patients adapt to their condition and perform self-care, starting during hospital stays and continuing in outpatient settings.

Nurses play a key role in this education process and need specialized training to effectively assess patient needs and provide education, with computer-based tools being a beneficial complement to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating nurses and patients to manage heart failure. Strömberg, A.[2017]

A multimedia educational intervention for heart failure patients significantly reduced unplanned hospital readmissions, with only 24 readmissions in the intervention group compared to 44 in the control group over 12 months (p=0.005).

The intervention led to a 30% reduction in the risk of readmission, demonstrating its effectiveness in improving self-care behaviors and health management for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care educational intervention to reduce hospitalisations in heart failure: A randomised controlled trial. Boyde, M., Peters, R., New, N., et al.[2019]

References

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

Patient education in heart failure. [2007]

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

Educational interventions for patients with heart failure: a systematic review of randomized controlled trials. [2022]

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

Effects of an interactive CD-program on 6 months readmission rate in patients with heart failure - a randomised, controlled trial [NCT00311194]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Learning needs of patients with congestive heart failure. [2022]

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

Instruments to measure acceptability of information and acquisition of knowledge in patients with heart failure. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

[Educational interventions in patients with heart failure: a review of the literature]. [2013]

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

"They diagnosed bad heart": a qualitative exploration of patients' knowledge about and experiences with heart failure. [2008]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? [2014]

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

Educating nurses and patients to manage heart failure. [2017]

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

Self-care educational intervention to reduce hospitalisations in heart failure: A randomised controlled trial. [2019]