Nurse-Led Education for Heart Failure Self-Care and Stability (EDUCATE)

Effectiveness of a Nurse-Led Face-to-Face Educational Intervention on Clinical Stability, Compliance, and Self-Care in Patients With Heart Failure Three Months After Hospital Discharge: An Open-Label Randomized Controlled Trial (EDUCATE Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Behavioral: Nurse-Led Face-to-Face Educational Intervention (Teach-Back Method)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Greta Ghizzardi, Ph.D.; Phone Number: + 39 0371376565; Email: greta.ghizzardi@asst-lodi.it
• Study Contact Backup: Name: Stefano Maiandi, Ph.D.; Phone Number: + 39 0371372739; Email: stefano.maiandi@asst-lodi.it

Study Locations

• Italy
  • Lodi
    • Lodi, Lodi, Italy, 26900
      • Azienda Socio Sanitaria Territoriale di Lodi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Hospital discharge from the Cardiology Unit of Lodi Hospital with a diagnosis of heart failure according to international guidelines
• NYHA functional class II-IV assigned at discharge
• First outpatient cardiology visit scheduled 30 (±15) days after hospital discharge
• Ability and willingness to provide written informed consent

Exclusion Criteria:

• Severe cognitive impairment (Six Item Screener score 0-3)
• Admission from a unit other than the Cardiology Department of Lodi Hospital
• NYHA class I
• First cardiology visit scheduled <30 or >45 days after discharge
• Previous enrollment or follow-up in any Heart Failure Clinic
• Acute coronary event within the previous 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse-Led Face-to-Face Educational Intervention; 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); 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.
No Intervention: Standard Follow-Up Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after the first outpatient cardiology visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3, 6, 9, and 12 months after the first outpatient cardiology visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3, 6, 9, and 12 months after the first outpatient cardiology visit

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale di Lodi
• Investigators: Principal Investigator: Greta Ghizzardi, Ph.D., Azienda Socio Sanitaria Territoriale di Lodi

Publications and helpful links

General Publications

• Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
• Centrella-Nigro AM, Alexander C. Using the Teach-Back Method in Patient Education to Improve Patient Satisfaction. J Contin Educ Nurs. 2017 Jan 1;48(1):47-52. doi: 10.3928/00220124-20170110-10.
• Alpert CM, Smith MA, Hummel SL, Hummel EK. Symptom burden in heart failure: assessment, impact on outcomes, and management. Heart Fail Rev. 2017 Jan;22(1):25-39. doi: 10.1007/s10741-016-9581-4.
• Riegel B, Dickson VV, Faulkner KM. The Situation-Specific Theory of Heart Failure Self-Care: Revised and Updated. J Cardiovasc Nurs. 2016 May-Jun;31(3):226-35. doi: 10.1097/JCN.0000000000000244.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Heart Failure; Randomized Controlled Trial; Patient Education; Medication Adherence; Self-Care; Teach-Back; Clinical Stability; Nurse-Led Intervention; Post-Discharge Care
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Heart Failure; Medication Adherence
• Other Study ID Numbers: EDUCATE Study; CET 195-2025 (Registry Identifier: registro dei pareri del CET Lombardia 1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No