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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if educating patients can improve adherence to heart failure treatment plans. The focus is on heart failure with reduced ejection fraction, where the heart doesn't pump as effectively as it should. Participants will attend educational sessions about their treatment's benefits and side effects at various intervals after hospital discharge. The trial seeks individuals hospitalized for heart failure with an ejection fraction of 40% or less. As an unphased trial, it offers a unique opportunity for patients to contribute to valuable research that could enhance treatment adherence and outcomes for heart failure patients.

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 prior data suggests that this patient education protocol is safe?

Research has shown that educating people about heart failure is a safe and effective way to support them. Studies have found that when patients understand their treatment, they manage their condition better. This includes taking medication correctly, making healthy lifestyle changes, and monitoring symptoms.

Patient education does not involve new drugs or medical procedures, so it avoids safety concerns like medication side effects. Instead, it provides information and support, building confidence and encouraging healthier habits.

In summary, patient education is safe and well-received. It helps people manage their heart health better without direct risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on enhancing patient education for heart failure management. Unlike standard treatments that primarily focus on medication, this approach emphasizes comprehensive education on guideline-directed medical therapy (GDMT), aiming to improve patient adherence and understanding. The intervention includes personalized education during hospital stays and follow-up sessions over the phone, providing ongoing support and addressing barriers to medication adherence. This proactive and educational approach could lead to better long-term outcomes for patients by empowering them to manage their condition more effectively.

What evidence suggests that patient education is effective for improving adherence to GDMT in heart failure with reduced ejection fraction?

Research has shown that educating patients about their condition can significantly aid those with heart failure. In this trial, participants in the intervention arm will receive comprehensive education, including face-to-face sessions and follow-up phone education. Studies have shown that this approach leads to fewer hospital visits and emergencies. Specifically, one study demonstrated that learning about their condition improved both the physical and mental health of patients. Those who received education experienced better treatment outcomes and fewer issues with their heart's ability to pump blood. Additionally, educating patients reduced death rates and increased their understanding of heart failure, enabling them to manage their care more effectively. Overall, patient education has proven highly beneficial for managing heart failure. ^{5 6 7 8 9}

Who Is on the Research Team?

Anup Agarwal, MD

Principal Investigator

MedStar Health

Are You a Good Fit for This Trial?

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

Hospitalized at one of the Medstar facilities (Inpatient)

Exclusion Criteria

Pregnancy

Patients with Heart failure Collaboratory Score (HFCS) of 9

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10196446/

Implementation of a heart failure educational intervention ... This study demonstrated that attending a one-time, two hour outpatient HF education class led to a decrease in ADHF, hospitalizations, ED visits ...

2. ijcva.org ijcva.org/articles/the-impact-of-patient-education-on-rehospitalization-rate-and-quality-of-life-in-heart-failure-patients/ijca.2025.70298

The Impact of Patient Education on Rehospitalization Rate ... Overall, the results suggest that patient education can significantly improve both physical and psychological outcomes for HF patients, while ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11057052/

A clinical study of heart failure education intervention - PMC Heart failure education intervention demonstrates effectiveness in improving the therapeutic outcomes for HF patients and reduced nonvalvular ejection fraction.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790702

Effectiveness and Cost-effectiveness of an Empowerment ... This randomized clinical trial compares self-care and cost-effectiveness outcomes between patients with heart failure who received an ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399122001367

Effects of educational intervention on mortality and patient ... The educational intervention reduced all-cause mortality in heart failure patients. · The intervention improved heart failure knowledge, self-care, and quality ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871465/

Health Literacy in Heart Failure: A Review of the Gaps and ... Health literacy has an essential role in heart failure (HF), contributing to medication adherence, disease self-management, and interactions with care ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8048442/

Self‐care of heart failure patients: practical management ... Heart failure guidelines stress the importance of patient education on treatment adherence, lifestyle changes, symptom monitoring and adequate response to ...

8. ahajournals.org ahajournals.org/doi/10.1161/hcq.0000000000000025

Evidence for Therapeutic Patient Education Interventions to ... The purpose of this scientific statement is to critique, analyze, and synthesize TPE evidence pertaining to self-management in selected cardiac ...

9. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09622-1

Experiences of patient education among people affected by ... This study provides valuable information about the problems of patient education for adults with cardiovascular disease.