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Clinical Trials in Italy / NCT07280728
Starting soon Not applicable

Nurse-Led Education for Heart Failure Self-Care and Stability

NCT07280728 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Socio Sanitaria Territoriale di Lodi
Phase
Not applicable
Started
2026-02-01
Last updated
2025-12-12

Condition(s) studied

Chronic Heart Failure

Investigational drug(s) / intervention(s)

Nurse-Led Face-to-Face Educational Intervention (Teach-Back Method)

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Azienda Socio Sanitaria Territoriale di Lodi Lodi Lodi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07280728 on ClinicalTrials.gov ↗ ← All trials in Italy