Keywords
Patient Education as Topic
Nursing Care
Self-Care
Medication Adherence
Teach-Back Communication
How to Cite
Abstract
Introduction. Heart failure (HF) is a chronic condition associated with substantial symptom burden, frequent hospitalisations, and increased morbidity and mortality. Nurse-led informational–educational interventions, particularly those based on the teach-back method, may support patients in monitoring and interpreting HF-related symptoms, improving self-care behaviours and medication adherence, and potentially contributing to long-term clinical stability after discharge.
Objective. To evaluate the effectiveness of a face-to-face nurse-led informational–educational intervention using the teach-back method on patient-reported perception and severity of HF-related somatic symptoms at 3 months after the first outpatient cardiology follow-up visit in patients recently discharged with HF.
Trial design. Single-centre, open-label, parallel-group randomised controlled trial with 1:1 allocation (intervention vs control).
Participants and Settings. Patients recently discharged from a cardiology unit with a diagnosis of HF will be enrolled and randomised at their first outpatient cardiology follow-up visit. Assessments will be conducted at baseline and at 3, 6, 9, and 12 months.
Interventions. The intervention consists of a 30-minute nurse-led face-to-face informational–educational session structured according to the teach-back method, focused on HF symptom monitoring, interpretation of worsening symptoms, and self-care behaviours. The session will be reinforced through a follow-up phone call. The control group will receive usual care.
Primary/Secondary Outcomes. The primary outcome is patient-reported symptom perception and severity of HF-related somatic symptoms at 3 months, measured using the Heart Failure Somatic Perception Scale (HFSPS). Secondary outcomes include self-care behaviours assessed with the Self-Care of Heart Failure Index (SCHFI v8.0), medication adherence measured using the General Medication Adherence Scale (GMAS), and clinical stability during follow-up. Disease-specific quality of life will be assessed exploratorily using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Ethical Considerations. Ethical approval has been obtained from the Comitato Etico Lombardia 1 (approval number CET 195-2025). The trial has been registered on ClinicalTrials.gov (identifier: NCT07280728).
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Copyright (c) 2026 Greta Ghizzardi, Martina Torreggiani, Ercole Vellone, Stefania Lorenzani, Fanny Zafferri, Luciana Ghizzinardi, Eleonora Aloi, Stefano Maiandi, Domenico Scognamiglio, Luca Poggio, Pietro Mazzarotto