Recruiting

Intensive Education

Sponsor:

Medstar Health Baltimore

Code:

NCT06273085

Conditions

Heart Failure

Patient Acceptance of Health Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Patient education

Study Details

Brief summary:

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.

Conditions

Heart Failure

Patient Acceptance of Health Care

Study ID

NCT06273085

Start date

Feb 1, 2024

Status verified date

Feb, 2024

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

no intervention: Control

Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT.

Interventions

Patient education

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.

Primary outcome measure

  • Change in GDMT score [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Anup Agarwal, MD

5066207815anup.agarwal@medstar.net

Sumanth Bandaru, MBBS

6462405289sumanthkumar.bandaru@medstar.net

Locations

Medstar Union Memorial Hospital

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Ahmad Amin, MD

401-533-0696ahmad.amin@medstar.net

Medstar Harbor Hospital

Recruiting

Baltimore, Maryland, United States, 21225

Contacts

Sumanth Bandaru, MBBS

646-240-5289sumanthkumar.bandaru@medstar.net

Medstar Franklin Medical Center

Recruiting

Baltimore, Maryland, United States, 21237

Contacts

Anup Agarwal, MD

505-620-7815anup.agarwal@medstar.net

Medstar Good Samaritan Hospital

Recruiting

Baltimore, Maryland, United States, 21239

Contacts

Sumanth Bandaru, MBBS

646-240-5289sumanthkumar.bandaru@medstar.net

More Information

Sponsor

Medstar Health Baltimore

Last update posted

Feb 26, 2024

Last verified

Feb, 2024

Keywords

  • heart failure with reduced ejection fraction
  • patient education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medstar Health Baltimore on 2024-02-26.