Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers
- Conditions
- Heart Failure
- Interventions
- Other: Intervention 1 / Nurse-led patients' educationOther: Intervention 2 / Nurse-led patients' & caregivers' education
- Registration Number
- NCT06545370
- Lead Sponsor
- Hellenic Mediterranean University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 280
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention 2 - Patients' and caregivers' education Intervention 1 / Nurse-led patients' 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 Intervention 2 - Patients' and caregivers' education Intervention 2 / Nurse-led patients' & 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 Intervention 1 group - Patients' education Intervention 1 / Nurse-led patients' education the first intervention group (Group B) will receive nurse-led education through oral sessions, educational materials, and regular phone calls
- Primary Outcome Measures
Name Time Method Heart Failure Patients' Quality of Life 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.
Medication adherence 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.
Heart failure patients' self-care 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).
- Secondary Outcome Measures
Name Time Method Caregivers' quality of life 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).
Caregiving burden 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.
Sense of guilt 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).
Trial Locations
- Locations (1)
Hellenic Mediterranean University
🇬🇷Heraklion, Crete, Greece