Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers

NCT ID: NCT06545370

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-09-01

Brief Summary

The current study intends to examine the influence of nurse-led education on patients with chronic heart failure and their caregivers, with the goal of optimizing care for both and improving patients' clinical outcomes.

Detailed Description

Introduction: Heart failure is a clinical syndrome with pandemic characteristics, and its prevalence increases with age. The development of self-care behavior by patients seems to be a crucial component for effective management and reduction of the disease's impact. Nurse- guided patient education has been associated with improved outcomes and the development of self-care behavior. In recent years, several studies have also focused on the contribution of informal caregivers to improving the outcomes of the disease. Nurse-led education for both patients and their caregivers has been shown to enhance their caregiving skills, leading to better disease management and beneficial outcomes.

Purpose: To investigate the impact of nurse-led education on patients with chronic heart failure and their caregivers, aiming to optimize care for both and improve the clinical outcomes of patients.

Methodology: A randomized controlled trial will be conducted with the manipulation of independent variables and the creation of a control group. Patients will be randomly assigned to three groups: a) the control group (Group A), receiving standard care based on the policies and protocols of primary health care; b) the first intervention group (Group B), receiving nurse-led education through oral sessions, educational materials, and regular phone calls; and c) the second intervention group (Group C), receiving the described nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials. Greek versions of the Minnesota Living with Heart Failure Questionnaire, Hippocratic Hypertension Self-Care Scale, and Self-Efficacy for Appropriate Medication Use Scale will be used to assess quality of life, self-care behavior, and medication adherence. For caregivers, their quality of life, caregiving burden, and sense of guilt will be evaluated using Greek versions of the EuroQol ED-5, Heart Failure Caregiver Questionnaire, and Caregiver Guilt Questionnaire, respectively. Measurements will be taken before patient and caregiver education (initial meeting), 1 month, and 6 months after the initial meeting. Statistical analysis will be performed using SPSS (version 26) and descriptive and inferential statistical analysis methods.

Expected Results: The proposed study is expected to highlight the contribution of nurse-led education in optimizing care for both patients and their caregivers. Additionally, this education is anticipated to lead to better clinical outcomes for patients with chronic heart failure.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group - No Intervention Group

the control group (Group A) will receive standard care based on the policies and protocols of primary health care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention 1 group - Patients' education

the first intervention group (Group B) will receive nurse-led education through oral sessions, educational materials, and regular phone calls

Group Type: EXPERIMENTAL

Intervention 1 / Nurse-led patients' education

Intervention Type: OTHER

nurse-led education through oral sessions, educational materials, and regular phone calls

Intervention 2 - Patients' and caregivers' education

the second intervention group (Group C) will receive the described nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials

Group Type: EXPERIMENTAL

Intervention 1 / Nurse-led patients' education

Intervention Type: OTHER

nurse-led education through oral sessions, educational materials, and regular phone calls

Intervention 2 / Nurse-led patients' & caregivers' education

Intervention Type: OTHER

nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials

Interventions

Intervention 1 / Nurse-led patients' education

nurse-led education through oral sessions, educational materials, and regular phone calls

Intervention Type: OTHER

Intervention 2 / Nurse-led patients' & caregivers' education

nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Mediterranean University

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Giakoumidakis

Associate Professor in Clinical Nursing - Chronic Diseases Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hellenic Mediterranean University

Heraklion, Crete, Greece

Site Status: COMPLETED

Hellenic Mediterranean University

Heraklion, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Konstantinos Giakoumidakis, Associate Professor

Role: CONTACT

kongiakoumidakis@hmu.gr

00306973793489

Elefteria Markaki, PhD candidate

Role: CONTACT

elefmarkaki@hmu.gr

00306944582422

Other Identifiers

10/28.05.2024

Identifier Type: -

Identifier Source: org_study_id