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

Hellenic Mediterranean University

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: Intervention 2 / Nurse-led patients' & caregivers' education; Other: Intervention 1 / Nurse-led patients' education

Study type: Interventional

Funder types: Other

Identifiers

NCT06545370

10/28.05.2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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280 participants in 3 patient groups

Control Group - No Intervention Group

No Intervention group

Description:

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 group

Description:

the first intervention group (Group B) will receive nurse-led education through oral sessions, educational materials, and regular phone calls

Treatment:

Other: Intervention 1 / Nurse-led patients' education

Intervention 2 - Patients' and caregivers' education

Experimental group

Description:

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

Treatment:

Other: Intervention 1 / Nurse-led patients' education

Other: Intervention 2 / Nurse-led patients' & caregivers' education