Nurse-Led Education for Heart Failure Self-Care and Stability (EDUCATE)

Azienda Socio Sanitaria Territoriale di Lodi

Status: Not yet enrolling

Conditions: Chronic Heart Failure

Treatments: Behavioral: Nurse-Led Face-to-Face Educational Intervention (Teach-Back Method)

Study type: Interventional

Funder types: Other

Identifiers

NCT07280728

EDUCATE Study

CET 195-2025 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Heart failure (HF) is a progressive chronic condition associated with high rates of readmission, mortality, and impaired quality of life. Adherence to therapy and self-care behaviors play a key role in maintaining clinical stability, yet many patients struggle to apply recommended management strategies after hospital discharge.

This randomized controlled trial (EDUCATE study) aims to assess the effectiveness of a nurse-led, face-to-face educational intervention on clinical stability, treatment compliance, and self-care in patients with HF during the post-discharge period. The intervention consists of a 30-minute educational session conducted by trained nurses during the first outpatient cardiology visit, approximately 30 days after discharge. The session includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials from Penn Nursing Science. A follow-up reinforcement phone call will be made one month later, and the educational session will be repeated at six months.

Participants will be randomly assigned (1:1) to either the intervention or control group. The control group will receive standard follow-up care, including monthly telephone contacts to support medication adherence and symptom monitoring. The primary outcome is clinical stability at three months, measured by the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care (Self-Care of Heart Failure Index 7.2) and medication compliance (Morisky 4-item Scale), assessed at 3, 6, 9, and 12 months.

The study will be conducted at the Heart Failure Clinic of ASST di Lodi, Italy, with an anticipated enrollment of 118 participants. The total study duration is 36 months, including 24 months of recruitment and 12 months of follow-up for the last enrolled participant.

Enrollment: 118 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Previous enrollment or follow-up in any Heart Failure Clinic
• Acute coronary event within the previous 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Nurse-Led Face-to-Face Educational Intervention

Experimental group

Description:

Participants in this arm will receive a structured 30-minute educational session conducted by trained nurses during the first outpatient cardiology visit, approximately 30 days after hospital discharge. The session includes symptom assessment, individualized education using the teach-back method, and delivery of educational materials developed by Penn Nursing Science. A reinforcement phone call will be made one month later, and the educational session will be repeated at six months.

Treatment:

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

Standard Follow-Up Care

No Intervention group

Description:

Participants in this arm will receive standard follow-up care, consisting of a 15-minute telephone contact one week after the first outpatient cardiology visit and monthly phone calls thereafter until 12 months post-discharge. During each call, nurses will reinforce medication adherence and collect basic clinical parameters such as blood pressure, heart rate, and weight.