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

NCT07280728 | Not Yet Recruiting DMC

• 2 other identifiers: EDUCATE StudyCET 195-2025
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Heart Failure

Keywords

Heart Failure; Self-Care; Patient Education; Nurse-Led Intervention; Teach-Back; Clinical Stability; Medication Adherence; Randomized Controlled Trial; Post-Discharge Care

Outcome Measures

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.

  3 months after the first outpatient cardiology visit.

Secondary Outcomes (2)

• Self-Care Lavels

  3, 6, 9, and 12 months after the first outpatient cardiology visit

• Medication Compliance

  3, 6, 9, and 12 months after the first outpatient cardiology visit

Other Outcomes (1)

• Health-Related Quality of Life

  3, 6, 9, and 12 months after the first outpatient cardiology visit

Study Arms (2)

Nurse-Led Face-to-Face Educational Intervention

EXPERIMENTAL

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.

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

Standard Follow-Up Care

NO INTERVENTION

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.

Interventions

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.

Nurse-Led Face-to-Face Educational Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale di Lodi: lead

Study Sites (1)

Azienda Socio Sanitaria Territoriale di Lodi

Lodi, Lodi, 26900, Italy

Location

Related Publications (4)

• Centrella-Nigro AM, Alexander C. Using the Teach-Back Method in Patient Education to Improve Patient Satisfaction. J Contin Educ Nurs. 2017 Jan 1;48(1):47-52. doi: 10.3928/00220124-20170110-10.

  PMID: 28099678 BACKGROUND

• Alpert CM, Smith MA, Hummel SL, Hummel EK. Symptom burden in heart failure: assessment, impact on outcomes, and management. Heart Fail Rev. 2017 Jan;22(1):25-39. doi: 10.1007/s10741-016-9581-4.

  PMID: 27592330 BACKGROUND

• Riegel B, Dickson VV, Faulkner KM. The Situation-Specific Theory of Heart Failure Self-Care: Revised and Updated. J Cardiovasc Nurs. 2016 May-Jun;31(3):226-35. doi: 10.1097/JCN.0000000000000244.

  PMID: 25774844 BACKGROUND

• Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.

  PMID: 35083827 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Greta Ghizzardi, Ph.D.

  Azienda Socio Sanitaria Territoriale di Lodi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greta Ghizzardi, Ph.D.

CONTACT

+ 39 0371376565; greta.ghizzardi@asst-lodi.it

Stefano Maiandi, Ph.D.

CONTACT

+ 39 0371372739; stefano.maiandi@asst-lodi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Researcher

Model Details: This is a single-center, open-label, randomized controlled trial with a 1:1 allocation ratio. Participants will be assigned to either the intervention group, receiving a structured nurse-led educational session using the teach-back method, or the control group, receiving standard follow-up care. Outcomes will be assessed at 3, 6, 9, and 12 months after enrollment.

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)