NCT07280728Not yet recruiting
Nurse-Led Education for Heart Failure Self-Care and Stability
Effectiveness of a Nurse-Led Face-to-Face Educational Intervention on Clinical Stability, Compliance, and Self-Care in Patients With Heart Failure Three Months After Hospital Discharge: An Open-Label Randomized Controlled Trial (EDUCATE Study)
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Azienda Socio Sanitaria Territoriale di Lodi
- Diseases
- Heart failure
- NCT number
- NCT07280728
What you commit to
- Study type: Interventional
- Planned participants: 118
- From 1 Feb 2026 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous enrollment or follow-up in any Heart Failure Clinic
- Acute coronary event within the previous 3 months
Other illness
- Severe cognitive impairment (Six Item Screener score 0-3)
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Socio Sanitaria Territoriale di Lodi Coordinator of this site? Confirm its status | Lodi | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.