Improving heart failure treatment through patient education
Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction- A Randomized Controlled Trial
This study is testing if extra education for heart failure patients during and after their hospital stay can help them stick to their treatment plan better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Baltimore Academic / other |
| Locations | 4 sites (Baltimore, Maryland and 3 other locations) |
| Trial ID | NCT06273085 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intensive patient education on the adherence to guideline-directed medical therapy (GDMT) for patients with heart failure and reduced ejection fraction. Participants will receive initial in-house education during hospitalization and will be randomized into two groups: one receiving standard education and the other receiving additional follow-up education via phone calls at 1, 3, and 5 months post-discharge. The study will assess the impact of this educational intervention on the use of GDMT after 6 months, focusing on improving patient understanding and adherence to treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with heart failure and reduced ejection fraction who are hospitalized at Medstar facilities.
Not a fit: Patients with advanced heart failure or other severe comorbidities that render GDMT futile will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient adherence to heart failure treatments, leading to better health outcomes.
How similar studies have performed: Previous studies have shown that patient education can improve adherence to treatment in chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%) * Age \>18 years * Able to consent for enrollment. * Hospitalized at one of the Medstar facilities (Inpatient) Exclusion Criteria: * Pregnancy * Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service * Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score \> 30, GFR (Glomerular filtration rate) \<25) in whom GDMT is Futile * Patients with Heart failure Collaboratory Score (HFCS) of 9
Where this trial is running
Baltimore, Maryland and 3 other locations
- Medstar Union Memorial Hospital — Baltimore, Maryland, United States (Recruiting)
- Medstar Harbor Hospital — Baltimore, Maryland, United States (Recruiting)
- Medstar Franklin Medical Center — Baltimore, Maryland, United States (Recruiting)
- Medstar Good Samaritan Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Anup Agarwal, MD — MedStar Health
- Study coordinator: Anup Agarwal, MD
- Email: anup.agarwal@medstar.net
- Phone: 5066207815
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.