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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHellenic Mediterranean University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Intervention 1 / Nurse-led patients' education

    Other intervention

    nurse-led education through oral sessions, educational materials, and regular phone calls

  • Intervention 2 / Nurse-led patients' & caregivers' education

    Other intervention

    nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Control Group - No Intervention GroupNo intervention 0 interventions
Group B: Intervention 1 group - Patients' educationExperimental treatment 1 intervention
Group C: Intervention 2 - Patients' and caregivers' educationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
2

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).

Time frame
from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
3

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.

Time frame
from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.

Secondary outcomes

1

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).

Time frame
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
2

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.

Time frame
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
3

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).

Time frame
From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hellenic Mediterranean University

Lead sponsor

Source ClinicalTrials.gov
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