Ultrasound + Education for Heart Failure

Overseen By Michelle Santangelo, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Acute heart failure, History of heart failure, others

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a quick ultrasound (a scan using sound waves) in the emergency room can help individuals with high blood pressure, diabetes, or obesity better understand their risk for heart failure. Researchers seek to assess whether this scan, combined with an educational session, encourages healthier eating, increased exercise, and adherence to follow-up care. Participants will receive either the educational intervention alone or both the ultrasound and educational intervention. The trial seeks adults aged 45 and older with high blood pressure, diabetes, or obesity, who currently show no symptoms of heart failure. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance heart health awareness and prevention strategies.

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 using point-of-care ultrasound (POCUS) is safe for increasing participant engagement and behavior change in heart failure prevention?

Research shows that ultrasound-based treatments are generally safe and can help manage heart diseases. Point-of-care ultrasound (POCUS) enables doctors to diagnose conditions like chest pain or cardiac arrest more quickly and accurately, improving patient care.

Although studies have not specifically examined the safety of POCUS, no major harm has been linked to its use. It is considered a safe addition to regular heart care. In this trial, when combined with educational programs, POCUS is expected to be safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of ultrasound and educational intervention for heart failure because it could offer a more holistic and personalized approach to managing the condition. Traditional treatments for heart failure often focus on medications and lifestyle changes, but this new method incorporates real-time ultrasound imaging to monitor heart function, potentially allowing for more precise adjustments to care. Additionally, coupling this with educational support empowers patients by enhancing their understanding and self-management skills, which could lead to improved outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that using ultrasound in education can greatly improve understanding of heart-related issues. In one study, 87% of participants reported better comprehension of cardiology topics when ultrasound was included in their learning. Another study found that 97% of participants correctly identified normal heart structures using ultrasound. Additionally, when patients learned to use lung ultrasound themselves, they felt more confident, suggesting that ultrasound can empower patients to manage their own care. This trial will compare two approaches: an Educational Intervention Alone and an Ultrasound and Educational Intervention. These findings suggest that combining ultrasound with education, as tested in this trial, might increase awareness of heart health and encourage lifestyle changes. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Gottlieb, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults at risk of developing pre-symptomatic heart failure who visit the emergency department. The study seeks individuals who have not yet shown symptoms but may benefit from early intervention.

Inclusion Criteria

I am 45 years old or older.

I have high blood pressure, diabetes, or a BMI of 30 or more.

Exclusion Criteria

I experience symptoms like difficulty breathing and leg swelling.

I have a history of heart failure.

Unable to tolerate an ultrasound examination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive either the educational intervention alone or an educational intervention plus POCUS

1 day

1 visit (in-person)

Immediate Post-Intervention Assessment

Participants report their understanding and likelihood to improve diet, exercise, and follow up immediately post-intervention

Immediately post-intervention

Follow-up

Participants are monitored for changes in diet, exercise, follow up, and self-efficacy at three months post-intervention

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention Alone
• Ultrasound and Educational Intervention

Trial Overview The study tests if adding point-of-care ultrasound (POCUS) to an educational program helps patients understand their condition better and encourages them to improve diet, exercise, and follow-up care compared to education alone.

How Is the Trial Designed?

Group I: Ultrasound and Educational Intervention Experimental Treatment 1 Intervention

Group II: Educational Intervention Alone Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

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]

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 structured heart failure education program significantly improved patients' knowledge about their condition and enhanced their self-management skills compared to a single lecture, as shown in a randomized controlled trial.

Both the education and control groups experienced improvements in disease status during rehabilitation, but those in the education program maintained better medication adherence and more frequently documented their self-tests six months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient education in heart failure improves disease-related knowledge and behavior during cardiac rehabilitation]. Glatz, J., Muschalla, B., Karger, G.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10742630/

Efficacy of Handheld Ultrasound in Medical Education A total of 83% for the acquisition and interpretation of cardiac and abdominal structures, but only 50% for the abdominal aorta. HHUS changed, ...

2. researchgate.net researchgate.net/publication/396610841_Educational_Methods_for_Teaching_Focused_Cardiac_Ultrasound_to_Medical_Students_A_Systematic_Review_of_Efficiency_Scalability_and_Outcomes

(PDF) Educational Methods for Teaching Focused Cardiac ... In 2017, 78% and in 2018, 87% reported that it improved the understanding of cardiology. Student ELS usage was high for 2017-2018 (93% and 70%) ...

3. bmcmededuc.biomedcentral.com bmcmededuc.biomedcentral.com/articles/10.1186/s12909-017-0928-x

The feasibility and efficacy of implementing a focused cardiac ... The average grade on the cardiac ultrasound view recognition test was 73%. Thirty students (97%) were able to correctly identify normal LV ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8497224/

Feasibility of patient‐performed lung ultrasound self‐ ... This pilot study reports that training HF patients to perform a LUS self‐exam is feasible, with reported high self‐efficacy.

5. mdpi.com mdpi.com/1660-4601/19/5/3033

Effectiveness of Ultrasound Cardiovascular Images in ... The present study aimed to evaluate the students' progress in evaluating ultrasound (US) and cadaveric cardiac images and long-time retention of information.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35369996/

Effects of educational intervention on mortality and patient ... Results: During the follow-up (median: 568 days), 7 deaths (12%) in the intervention group and 15 deaths (24%) in the control group occurred (adjusted hazard ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2474870624001040

Role of Ultrasound-Based Therapies in Cardiovascular ... Ultrasound-based therapies are, therefore, a potential adjunct and comparatively safe adjuncts for managing challenging CVD cases. Further investigations are ...

8. jems.com jems.com/patient-care/study-prehospital-lung-ultrasound-improves-diagnoses-of-acute-heart-failure/

Study: Prehospital Lung Ultrasound Improves Diagnoses of ... Our study revealed that without advanced diagnostic tools, paramedics correctly identified AHF in only 23% of cases. This low rate translates to ...

9. nature.com nature.com/articles/s41586-023-05947-3

Blinded, randomized trial of sonographer versus AI cardiac ... The mean absolute difference between the initial and final assessments of LVEF was 2.79% in the AI group compared with 3.77% in the sonographer ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805123/

Point-of-Care Ultrasound for the Diagnosis of Frequent ... Studies show that POCUS improves diagnostic speed, accuracy, and patient outcomes in scenarios like dyspnea, chest pain, and cardiac arrest. In ...