An interventional study of Patient education in Heart Failure and Patient Acceptance of Health Care, sponsored by Medstar Health Baltimore. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Medstar Health Baltimore · Not applicable, Interventional, and Treatment
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.
This is a randomized clinical trial assessing the possible benefit of post-discharge education on the extent of guideline directed medical treatment for heart failure with reduced ejection fraction. Patients that are admitted to medical facilities of the Medstar health, Baltimore will be screened and if consented, they will all get an initial inhouse face to face education, and upon discharge, they will be randomized to the control group and intervention group. The latter will get more educations via phone-call sessions at 1, 3 and 5 months post discharge. The educational sessions will include educating the benefits of GDMT, reviewing the components of GDMT and their possible side effects, performing Medication reconciliation, Inquiries about reasons not getting the medications and encouraging adherence to clinic visits and requesting the treating providers for GDMT optimization. There will be no formal prescription or change of medication during the educational sessions. GDMT use will be assessed in all patients after 6 months according to GDMT score by the Heart Failure Collaboratory.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 500 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Medstar Health Baltimore as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Patient education
Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT.
3 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.
Change in GDMT score
Changes in GDMT score defined by the Heart Failure Collaboratory (Vericiguat and Ivabradine score will not be included in this study)
Time frame: 6 months
Heart Failure hospitalization
Proportion of Heart failure hospitalization
Time frame: 6 months
cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant
Proportion of cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant
Time frame: 6 months
Number of GDMT classes of medications in use
Number of GDMT classes of medications in use
Time frame: 6 months
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