Heart FailureNCT07280208
Teach-Back Discharge Education to Improve Self-Care and Reduce 30-Day Readmissions in Heart Failure Patients
A study testing Teach-Back Discharge Education in people with Heart Failure and Heart Failure Hospitalization, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure Hospitalization, Readmission, Hospital
- What is being tested?
- Teach-Back Discharge Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment
- Non-English speaking
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Discharge Teach-Back Education on Heart Failure Patients' Knowledge/Self-Care Behaviors and 30-Day Readmissions
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.
Read the detailed description
Heart failure is a chronic and progressive condition affecting millions of adults in the United States. Despite advances in treatment, nearly one in four patients are readmitted to the hospital within 30 days of discharge, often due to poor understanding of discharge instructions and inadequate self-care. These readmissions contribute to worse health outcomes and increased healthcare costs.
This study evaluated the effectiveness of a structured discharge education intervention using the teach-back method. The teach-back method is a communication technique in which patients are asked to repeat discharge instructions in their own words. This approach helps confirm understanding, reinforce learning, and promote active engagement in self-care.
The study used a quasi-experimental, pre-test/post-test design to assess changes in patients' knowledge and self-care behaviors before and after the intervention. Participants were adults hospitalized with systolic heart failure (LVEF ≤ 40%) who meet specific clinical criteria. Each participant received a 30-minute individualized education session at discharge, covering key self-care topics such as medication adherence, symptom monitoring, fluid restriction, and dietary modifications. Printed educational materials from the American Heart Association were also provided.
To measure outcomes, participants completed the European Heart Failure Self-care Behavior Scale (EHFScB-9) before and after the intervention. Thirty-day readmission data was collected through a retrospective review of hospital records. The study aimed to determine whether teach-back education improved self-care behaviors and reduced 30-day readmission rates.
This project was reviewed and exempted by the Nova Southeastern University Institutional Review Board under Exempt Category 2. It aligned with national goals to improve patient education, reduce preventable readmissions, and enhance the quality of care for individuals with heart failure.
- Being tested
- Teach-Back Discharge Education
- Keywords
- heart failure, hospital readmission, patient education, teach-back method, self-care, health literacy, discharge planning, transitional care, evidence-based practice, nursing intervention, quality improvement, systolic heart failure, medication adherence, symptom monitoring, lifestyle modification
- Medical subject headings
- Heart Failure, Heart Failure, Systolic, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-Back Discharge EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Teach-Back Discharge Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Readmission status was determined from hospital records and participants were classified as readmitted (Yes) or not readmitted (No) within 30 days of discharge. Data are displayed as counts in the results table.
Measured: Assessed during the 30-day period following hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start11 Sep 2025
- Primary completion11 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Bierschenk, Nova Southeastern University
- Investigators
- Virginia Waters, Ph.D., MSN, MBA, RN, CNE-BC, Study chair, Nova Southeastern University, Ron and Kathy Assaf College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280208
- Sponsor's protocol ID
- 2025-398
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2025
- Last updated
- 25 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Discharge Teach-Back Education on Heart Failure Patients' Knowledge/Self-Care Behaviors and 30-Day Readmissions
- ClinicalTrials.gov ID
- NCT07280208
- Acronym / sponsor ID
- 2025-398
- Keywords
- heart failure, hospital readmission, patient education, teach-back method, self-care, health literacy, discharge planning, transitional care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 12 Dec 2025 (actual)
- Results
- Posted 25 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure is a chronic and progressive condition affecting millions of adults in the United States. Despite advances in treatment, nearly one in four patients are readmitted to the hospital within 30 days of discharge, often due to poor understanding of discharge instructions and inadequate self-care. These readmissions contribute to worse health outcomes and increased healthcare costs.
This study evaluated the effectiveness of a structured discharge education intervention using the teach-back method. The teach-back method is a communication technique in which patients are asked to repeat discharge instructions in their own words. This approach helps confirm understanding, reinforce learning, and promote active engagement in self-care.
The study used a quasi-experimental, pre-test/post-test design to assess changes in patients' knowledge and self-care behaviors before and after the intervention. Participants were adults hospitalized with systolic heart failure (LVEF ≤ 40%) who meet specific clinical criteria. Each participant received a 30-minute individualized education session at discharge, covering key self-care topics such as medication adherence, symptom monitoring, fluid restriction, and dietary modifications. Printed educational materials from the American Heart Association were also provided.
To measure outcomes, participants completed the European Heart Failure Self-care Behavior Scale (EHFScB-9) before and after the intervention. Thirty-day readmission data was collected through a retrospective review of hospital records. The study aimed to determine whether teach-back education improved self-care behaviors and reduced 30-day readmission rates.
This project was reviewed and exempted by the Nova Southeastern University Institutional Review Board under Exempt Category 2. It aligned with national goals to improve patient education, reduce preventable readmissions, and enhance the quality of care for individuals with heart failure.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Teach-Back Education Intervention | Experimental | Behavioral: Teach-Back Discharge EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment
- Non-English speaking
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach-Back Discharge EducationA 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. | Behavioural | Teach-Back Education Intervention |
Primary outcome
Change in Heart Failure Self-Care Behaviors (EHFScB-9 Total Score)
Time frame: Baseline (pre-intervention) and immediately post-intervention on the same day, up to 35 minutes after the start of the education session.
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).
1 secondary outcome
Number of Participants With 30-Day Heart Failure Readmission
Time frame: Assessed during the 30-day period following hospital discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Waters, Ph.D., MSN, MBA, RN, CNE-BC study chair
Nova Southeastern University, Ron and Kathy Assaf College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-Back Discharge Education in people with Heart Failure and Heart Failure Hospitalization, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Failure Self-Care Behaviors (EHFScB-9 Total Score) (time frame: Baseline (pre-intervention) and immediately post-intervention on the same day, up to 35 minutes after the start of the education session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.