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

September 19, 2025 updated by: Konstantinos Giakoumidakis, Hellenic Mediterranean University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Konstantinos Giakoumidakis, Associate Professor
  • Phone Number: 00306973793489
  • Email: kongiakoumidakis@hmu.gr

Study Contact Backup

  • Name: Elefteria Markaki, PhD candidate
  • Phone Number: 00306944582422
  • Email: elefmarkaki@hmu.gr

Study Locations

  • Greece
      • Heraklion, Greece
        • Recruiting
        • Hellenic Mediterranean University
    • Crete
      • Heraklion, Crete, Greece, 71410
        • Completed
        • Hellenic Mediterranean University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group - No Intervention Group
the control group (Group A) will receive standard care based on the policies and protocols of primary health care
Experimental: 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
Other: Intervention 1 / Nurse-led patients' education
nurse-led education through oral sessions, educational materials, and regular phone calls
Experimental: 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
Other: Intervention 1 / Nurse-led patients' education
nurse-led education through oral sessions, educational materials, and regular phone calls
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Patients' Quality of Life
Time Frame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
The heart failure patient's quality of life: To assess the quality of life of patients with heart failure, the Greek version of the Minnesota Living with Heart Failure Questionnaire (MLwHFQ) was used.
from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Heart failure patients' self-care
Time Frame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
The self-care behavior of heart failure patients: The Hippocratic Heart Failure Self-Care Scale is an 18-item scale created by Greek researchers (Brokalaki et al., 2024).
from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Medication adherence
Time Frame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
The adherence of pharmacological treatment to heart failure patients: To assess adherence to medication in patients with cardiac deficiency, the Greek version of SEAMS will be used (Theofilou, 2023). SEAMS is a 13-item self-report medication adherence scale.
from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregivers' quality of life
Time Frame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
The quality of life of heart failure patients' caregivers: Assessing the quality of life of caregivers of heart failure patients will be done using the Greek version of the EuroQol EQ-5D tool (Kontodimopoulos et al., 2008).
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Caregiving burden
Time Frame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
The burden of the heart failure patients' caregivers: The assessment of the burden of caregivers of heart failure patients will be done through the Greek version of the HF Caregiver Questionnaire.
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Sense of guilt
Time Frame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
The sense of guilt among heart failure patients' caregivers: Assessing the guilt of caregivers of heart failure patients will be done through the Greek version of the Caregiver Guilt Questionnaire (CGQ).
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Mediterranean University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/28.05.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share individual participant data (IPD) collected in this study due to concerns about patient privacy, and lack of infrastructure for data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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