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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Heart Failure Patients' Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Heart Failure Patients' Quality of Life
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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.)
研究者
Konstantinos Giakoumidakis
Associate Professor in Clinical Nursing - Chronic Diseases Management
Hellenic Mediterranean University