NCT07280208

Brief Summary

This study aimed to improve how patients with heart failure understand and manage their condition after leaving the hospital. Many heart failure patients are readmitted within 30 days due to confusion about their discharge instructions and difficulty following self-care routines. The study tested whether a structured discharge education session using the "teach-back" method-where patients repeated instructions in their own words-could help improve their knowledge and self-care behaviors. The goal was to reduce hospital readmissions and help patients feel more confident managing their heart failure at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

November 29, 2025

Results QC Date

December 26, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

heart failurehospital readmissionpatient educationteach-back methodself-carehealth literacydischarge planningtransitional careevidence-based practicenursing interventionquality improvementsystolic heart failuremedication adherencesymptom monitoringlifestyle modification

Outcome Measures

Primary Outcomes (1)

  • Change in Heart Failure Self-Care Behaviors (EHFScB-9 Total Score)

    The 9-item European Heart Failure Self-Care Behavior Scale (EHFScB-9) was used to assess self-care behaviors. Each item is scored on a 5-point Likert scale ranging from 1 ("completely agree") to 5 ("do not agree at all"), producing a total score range of 9 to 45. The outcome represents the change in total EHFScB-9 score from baseline (pre-intervention) to immediately post-intervention following the discharge education session. Lower total scores indicate better self-care performance (more consistent adherence to recommended behaviors), while higher total scores indicate poorer self-care performance (less consistent adherence).

    Baseline (pre-intervention) and immediately post-intervention on the same day, up to 35 minutes after the start of the education session.

Secondary Outcomes (1)

  • Number of Participants With 30-Day Heart Failure Readmission

    Assessed during the 30-day period following hospital discharge.

Study Arms (1)

Teach-Back Education Intervention

EXPERIMENTAL

Participants in this arm received a structured discharge education session using the teach-back method. The session was delivered in person at hospital discharge and covered key heart failure self-care behaviors, including medication adherence, symptom monitoring, fluid restriction, and dietary modifications. Participants were asked to restate instructions in their own words to confirm understanding. Printed educational materials from the American Heart Association were also provided.

Behavioral: Teach-Back Discharge Education

Interventions

A structured, 30-minute discharge education session delivered in person using the teach-back method. Participants are asked to restate instructions in their own words to confirm understanding. The session covers key heart failure self-care behaviors including medication adherence, symptom monitoring, fluid restriction, and dietary modifications. Printed educational materials from the American Heart Association are also provided.

Teach-Back Education Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years and older
  • Diagnosed with systolic heart failure with a left ventricular ejection fraction (LVEF) ≤ 40%
  • Classified as New York Heart Association (NYHA) Class II, III, or IV
  • Categorized as American College of Cardiology/American Heart Association (ACC/AHA) Stage C or D
  • Currently hospitalized at the project site
  • Able to read and understand English at an 8th grade reading level
  • Have access to a smartphone or tablet capable of scanning QR codes and connecting to the internet
  • Provide voluntary informed consent via the REDCap platform

You may not qualify if:

  • Cognitive impairment
  • Non-English speaking
  • Unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HCA Florida JFK Hospital

Atlantis, Florida, 33462, United States

Location

MeSH Terms

Conditions

Heart FailureHeart Failure, SystolicMedication Adherence

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

This was a single-site quality improvement study with a small sample size, which may limit generalizability of findings. Demographic data such as age, race, and ethnicity were not collected, which restricts subgroup analysis. The short follow-up period (30 days) may not capture long-term outcomes.

Results Point of Contact

Title
Sara Bierschenk, Principal Investigator
Organization
Nova Southeastern University - Ron and Kathy Assaf College of Nursing

Study Officials

  • Virginia Waters, Ph.D., MSN, MBA, RN, CNE-BC

    Nova Southeastern University, Ron and Kathy Assaf College of Nursing

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All participants received the same intervention: structured discharge education using the teach-back method. There was no control group or comparison between multiple interventions. The study used a pre-test/post-test design within a single group to evaluate changes in self-care behaviors and readmission rates.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2025

First Posted

December 12, 2025

Study Start

September 11, 2025

Primary Completion

October 11, 2025

Study Completion

November 10, 2025

Last Updated

February 25, 2026

Results First Posted

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared for this study. The data collected will be used solely for the purposes of evaluating the effectiveness of the discharge teach-back education intervention on heart failure self-care behaviors and 30-day readmissions. All data will be stored securely and managed in compliance with HIPAA and IRB regulations. Due to the sensitive nature of health information and the limited scope of the study, there is no plan to make IPD publicly available.

Locations