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

NCT07280728 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-12-12

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale di Lodi

    lead OTHER

Principal Investigators

  • Greta Ghizzardi, Ph.D. · Azienda Socio Sanitaria Territoriale di Lodi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-02-01
Completion
2029-02-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280728 on ClinicalTrials.gov