An interventional study of Nurse-Led Face-to-Face Educational Intervention (Teach-Back Method) in Chronic Heart Failure, sponsored by Azienda Socio Sanitaria Territoriale di Lodi. Not yet recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Azienda Socio Sanitaria Territoriale di Lodi · Not applicable, Interventional, and Treatment
Heart failure is a chronic condition that can lead to frequent hospitalizations and reduced quality of life. This study aims to evaluate whether a nurse-led, face-to-face educational intervention can improve clinical stability, treatment compliance, and self-care behaviors among patients with heart failure after hospital discharge. Participants will be randomly assigned to either the intervention group, receiving a structured 30-minute educational session using the teach-back method, or the control group, receiving standard follow-up care. The primary outcome is clinical stability at three months, assessed using the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care and medication compliance measured up to 12 months. The study will be conducted at the ASST di Lodi Heart Failure Clinic in Italy and is expected to last three years.
Heart failure (HF) is a progressive chronic condition associated with high rates of readmission, mortality, and impaired quality of life. Adherence to therapy and self-care behaviors play a key role in maintaining clinical stability, yet many patients struggle to apply recommended management strategies after hospital discharge.
This randomized controlled trial (EDUCATE study) aims to assess the effectiveness of a nurse-led, face-to-face educational intervention on clinical stability, treatment compliance, and self-care in patients with HF during the post-discharge period. The intervention consists of a 30-minute educational session conducted by trained nurses during the first outpatient cardiology visit, approximately 30 days after discharge. The session includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials from Penn Nursing Science. A follow-up reinforcement phone call will be made one month later, and the educational session will be repeated at six months.
Participants will be randomly assigned (1:1) to either the intervention or control group. The control group will receive standard follow-up care, including monthly telephone contacts to support medication adherence and symptom monitoring. The primary outcome is clinical stability at three months, measured by the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care (Self-Care of Heart Failure Index 7.2) and medication compliance (Morisky 4-item Scale), assessed at 3, 6, 9, and 12 months.
The study will be conducted at the Heart Failure Clinic of ASST di Lodi, Italy, with an anticipated enrollment of 118 participants. The total study duration is 36 months, including 24 months of recruitment and 12 months of follow-up for the last enrolled participant.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 118 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Azienda Socio Sanitaria Territoriale di Lodi is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive a structured 30-minute educational session conducted by trained nurses during the first outpatient cardiology visit, approximately 30 days after hospital discharge. The session includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials developed by Penn Nursing Science. A reinforcement phone call will be made one month later, and the educational session will be repeated at six months.
Behavioral: Nurse-Led Face-to-Face Educational Intervention (Teach-Back Method)
Participants in this arm will receive standard follow-up care, consisting of a 15-minute telephone contact one week after the first outpatient cardiology visit and monthly phone calls thereafter until 12 months post-discharge. During each call, nurses will reinforce medication adherence and collect basic clinical parameters such as blood pressure, heart rate, and weight.
A 30-minute structured educational session delivered by trained nurses during the first outpatient cardiology visit (about 30 days after discharge). The intervention includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials from Penn Nursing Science. A reinforcement phone call will be conducted one month later, and the session repeated at six months.
Clinical Stability at 3 Months
Clinical stability will be assessed using the Heart Failure Somatic Perception Scale (HFSPS). The scale measures symptom perception in heart failure. A difference of at least 7 points between intervention and control groups (favoring the intervention) is hypothesized.
Time frame: 3 months after the first outpatient cardiology visit.
Self-Care Lavels
Self-care behaviors will be assessed using the Self-Care of Heart Failure Index version 7.2 (SCHFI 7.2). Higher scores indicate better self-care; scores \>70 are considered adequate.
Time frame: 3, 6, 9, and 12 months after the first outpatient cardiology visit
Medication Compliance
Medication adherence will be measured with the 4-item Morisky Scale. A total score of 4 indicates high adherence. The proportion of participants reporting full adherence ("No" to all items) will be compared between groups.
Time frame: 3, 6, 9, and 12 months after the first outpatient cardiology visit
Health-Related Quality of Life
Health-related quality of life will be measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Higher scores indicate better perceived quality of life and lower symptom burden.
Time frame: 3, 6, 9, and 12 months after the first outpatient cardiology visit
Plan to share: No — Individual participant data (IPD) will not be shared because the study involves clinical data collected within a single institution and is subject to privacy and data protection regulations under the EU General Data Protection Regulation (GDPR). Only aggregated, anonymized results will be made available in scientific publications or presentations.
Start is estimated for Feb 2026; primary completion for Feb 2028, 24 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 24 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Azienda Socio Sanitaria Territoriale di Lodi