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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group - No Intervention Group | No Intervention | the control group (Group A) will receive standard care based on the policies and protocols of primary health care | |
| Intervention 1 group - Patients' education | Experimental | the 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1 / Nurse-led patients' education | Other | nurse-led education through oral sessions, educational materials, and regular phone calls |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Caregivers' quality of life | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Konstantinos Giakoumidakis, Associate Professor | Contact | 00306973793489 | kongiakoumidakis@hmu.gr | |
| Elefteria Markaki, PhD candidate | Contact | 00306944582422 | elefmarkaki@hmu.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Mediterranean University | Completed | Heraklion | Crete | 71410 | Greece | |
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
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Intervention 2 / Nurse-led patients' & caregivers' education | Other | nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials |
|
| Caregiving burden | 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 | 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. |
| Hellenic Mediterranean University |
| Recruiting |
| Heraklion |
| Greece |