Nurse-led Education on Patients 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
1 other identifier
interventional
280
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Sep 2024
Typical duration for not_applicable heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 9, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 24, 2025
September 1, 2025
2 years
July 25, 2024
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Heart Failure Patients' Quality of Life
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
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
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 Outcomes (3)
Caregivers' quality of life
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Caregiving burden
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Sense of guilt
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Study Arms (3)
Control Group - No Intervention Group
NO INTERVENTIONthe control group (Group A) will receive standard care based on the policies and protocols of primary health care
Intervention 1 group - Patients' education
EXPERIMENTALthe first intervention group (Group B) will receive nurse-led education through oral sessions, educational materials, and regular phone calls
Intervention 2 - Patients' and caregivers' education
EXPERIMENTALthe 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
Interventions
nurse-led education through oral sessions, educational materials, and regular phone calls
nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hellenic Mediterranean University
Heraklion, Crete, 71410, Greece
Hellenic Mediterranean University
Heraklion, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in Clinical Nursing - Chronic Diseases Management
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 9, 2024
Study Start
September 1, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
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