Clinical trial NCT06545370: Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
informal caregivers
patient outcomes
nurse-led education
Lead sponsor: Hellenic Mediterranean University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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\&#39; 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\&#39;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.

Eligibility criteria: 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\&#39;s disease (for patients and caregivers)
* Absence of an informal caregiver according to their statement

Primary outcomes:
measure: Heart Failure Patients' Quality of Life
timeFrame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
measure: Heart failure patients' self-care
timeFrame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
measure: Medication adherence
timeFrame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Secondary outcomes:
measure: Caregivers' quality of life
timeFrame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
measure: Caregiving burden
timeFrame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
measure: Sense of guilt
timeFrame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Hellenic Mediterranean University
state: Crete
Study officials:
References: