Nurse-led education for people with chronic heart failure and their informal caregivers

The Impact of Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers in Optimizing the Care for Both and Improving the Clinical Outcomes of Patients

This trial will test whether nurse-led education given to patients with chronic heart failure, either alone or together with their informal caregivers, helps patients manage their condition and improves clinical outcomes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hellenic Mediterranean University (other)
• Locations: 2 sites (Heraklion, Crete and 1 other locations)
• Trial ID: NCT06545370 on ClinicalTrials.gov

What this trial studies

This is a randomized controlled trial that assigns recently hospitalized patients with chronic heart failure to one of three arms: usual primary care, nurse-led patient education, or nurse-led education that also trains the informal caregiver. The nurse-led interventions combine oral teaching sessions, written educational materials, and regular follow-up phone calls to reinforce self-care and medication adherence. Key outcomes include patient self-care behaviors, clinical outcomes such as rehospitalization and symptom control, and caregiver caregiving skills. The trial enrolls Greek-literate adults with established heart failure and their informal caregivers and is conducted at the Hellenic Mediterranean University in Heraklion, Crete.

Who should consider this trial

Good fit: Adults (≥18) recently hospitalized for chronic heart failure, diagnosed for at least 6 months, literate in Greek, taking guideline-directed medications, and who have an informal caregiver involved for at least 6 months.

Not a fit: Patients without an informal caregiver, those not literate in Greek, or individuals with dementia, significant psychiatric illness, or recent substance abuse are unlikely to be eligible or to benefit from the intervention as designed.

Why it matters

Potential benefit: If successful, the program could improve patients' self-care and symptom control, reduce rehospitalizations, and strengthen caregiver skills and patient quality of life.

How similar studies have performed: Prior trials and nonrandomized studies of nurse-led education and caregiver involvement have generally shown improvements in self-care, adherence, and reduced readmissions, so this approach has supportive but not definitive evidence.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* Patients recently hospitalized due to the disease
* Patients and caregivers who are literate in Greek
* Patients and caregivers who provide written informed consent for their participation in the study
* Patients diagnosed with heart failure for at least 6 months
* Caregivers who have been involved in the care of the patients for at least 6 months
* Patients taking medication according to the guidelines of the European Society of Cardiology

Exclusion Criteria:

* History of psychiatric disease, recent history of alcohol or/and drug abuse, dementia, and Alzheimer\'s disease (for patients and caregivers)
* Absence of an informal caregiver according to their statement

Where this trial is running

Heraklion, Crete and 1 other locations

• Hellenic Mediterranean University — Heraklion, Crete, Greece (COMPLETED)
• Hellenic Mediterranean University — Heraklion, Greece (RECRUITING)

Study contacts

• Study coordinator: Konstantinos Giakoumidakis, Associate Professor

Conditions: Heart Failure, Heart failure, informal caregivers, patient outcomes, nurse-led education