100 Participants Needed

Ultrasound + Education for Heart Failure

AO
MS
Overseen ByMichelle Santangelo, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center

Trial Summary

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 treatment Educational Intervention Alone, Ultrasound and Educational Intervention for heart failure?

Research shows that educational programs led by nurses can improve heart failure knowledge and self-care, leading to better patient outcomes. Additionally, home-based nursing interventions have been found to enhance disease management and knowledge in heart failure patients.12345

Is the combination of ultrasound and educational intervention safe for humans?

The research articles focus on educational interventions for heart failure, which are generally safe and aim to improve patient knowledge and reduce hospital readmissions. However, they do not provide specific safety data on the combination of ultrasound and educational intervention.56789

How does the Ultrasound + Education treatment for heart failure differ from other treatments?

This treatment is unique because it combines ultrasound imaging with educational interventions to help patients better understand and manage their heart failure. While education is a common part of heart failure management, the addition of ultrasound may provide patients with a visual understanding of their condition, potentially enhancing the effectiveness of the educational component.710111213

What is the purpose of this trial?

The goal of this clinical trial is to learn if using point-of-care ultrasound (POCUS) can increase participant engagement and changes in behavior among adults with risk factors for pre-symptomatic heart failure presenting to the emergency department. The main questions it aims to answer are:1. Does POCUS increase understanding of heart failure and the likelihood to improve diet, exercise, and follow up?2. Does POCUS improve diet, exercise, follow up, and self-efficacy at three months post-intervention?Researchers will compare an educational intervention with versus without POCUS to see if POCUS works to improve outcomes.Participants will:Receive either the educational intervention alone or an educational intervention plus POCUS. They will report the difference in their understanding and likelihood to improve diet, exercise, and follow up immediately post-intervention. They will also report changes in diet, exercise, follow up, and self-efficacy at three months post-intervention.

Research Team

MG

Michael Gottlieb, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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
See 1 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ultrasound and Educational InterventionExperimental Treatment1 Intervention
Group II: Educational Intervention AlonePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

Findings from Research

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

References

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]
Home-based nursing interventions improve knowledge of disease and management in patients with heart failure. [2022]
Therapeutic patient education in heart failure: do studies provide sufficient information about the educational programme? [2014]
Rationale and design of a risk-guided strategy for reducing readmissions for acute decompensated heart failure: the Risk-HF study. [2022]
[Randomized controlled clinical trial of a home care unit intervention to reduce readmission and death rates in patients discharged from hospital following admission for heart failure]. [2019]
Randomized trial of an education and support intervention to prevent readmission of patients with heart failure. [2022]
Effects of the characteristics of teaching on the outcomes of heart failure patient education interventions: a systematic review. [2022]
Computer-based education for patients with chronic heart failure. A randomised, controlled, multicentre trial of the effects on knowledge, compliance and quality of life. [2015]
Effect of Educational Interventions to Reduce Readmissions due to Heart Failure Decompensation in Adults: a Systematic Review and Meta-analysis. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Pilot Randomized Controlled Trial to Reduce Readmission for Heart Failure Using Novel Tablet and Nurse Practitioner Education. [2019]
[Patient education in heart failure improves disease-related knowledge and behavior during cardiac rehabilitation]. [2014]
12.United Statespubmed.ncbi.nlm.nih.gov
A Pilot Study on Standardized In-hospital Education About Heart Failure Conducted During the First Days After Decompensation. [2023]
Learning style and learning needs of heart failure patients (The Need2Know-HF patient study). [2022]
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