About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Nurse-Led Face-to-Face Educational Intervention (Teach-Back Method)
BehavioralA 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Other outcomes
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.
Sponsors and contacts
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