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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAzienda Socio Sanitaria Territoriale di Lodi

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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.

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Nurse-Led Face-to-Face Educational InterventionExperimental treatment 1 intervention
Group B: Standard Follow-Up CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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
2

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

Other outcomes

1

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

Sponsors and contacts

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