Heart FailureNCT06545370
Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers
A study testing Intervention 1 / Nurse-led patients' education and Intervention 2 / Nurse-led patients' & caregivers' education in people with Heart Failure, run by Hellenic Mediterranean University at 2 sites in Greece.
Trial 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\' clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Intervention 1 / Nurse-led patients' education and Intervention 2 / Nurse-led patients' & caregivers' education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 1 recruiting
- Completed
Hellenic Mediterranean University
Heraklion, Crete, 71410
- Recruiting
Hellenic Mediterranean University
Heraklion
About this study
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
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.
Read the 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\'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.
- Conditions
- Heart Failure
- Being tested
- Intervention 1 / Nurse-led patients' education, Intervention 2 / Nurse-led patients' & caregivers' education
- Keywords
- Heart failure, informal caregivers, patient outcomes, nurse-led education
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1 / Nurse-led patients' educationOther
nurse-led education through oral sessions, educational materials, and regular phone calls
Intervention 2 / Nurse-led patients' & caregivers' educationOther
nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Intervention 1 / Nurse-led patients' education |
| 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 Receives: Other: Intervention 1 / Nurse-led patients' education; Other: Intervention 2 / Nurse-led patients' & caregivers' education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Secondary outcomes (3)
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).
Measured: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
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.
Measured: 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).
Measured: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Giakoumidakis, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545370
- Sponsor's protocol ID
- 10/28.05.2024
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06545370
- Acronym / sponsor ID
- 10/28.05.2024
- Conditions
- Heart Failure
- Keywords
- Heart failure, informal caregivers, patient outcomes, nurse-led education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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\'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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Intervention 1 / Nurse-led patients' educationthe 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 | Other: Intervention 1 / Nurse-led patients' education, Other: Intervention 2 / Nurse-led patients' & caregivers' educationthe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1 / Nurse-led patients' educationnurse-led education through oral sessions, educational materials, and regular phone calls | Other | Intervention 1 group - Patients' education, Intervention 2 - Patients' and caregivers' education |
| Intervention 2 / Nurse-led patients' & caregivers' educationnurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials | Other | Intervention 2 - Patients' and caregivers' education |
Primary outcome
Heart Failure Patients' Quality of Life
Time frame: 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.
Heart failure patients' self-care
Time frame: 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).
Medication adherence
Time frame: 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.
3 secondary outcomes
Caregivers' quality of life
Time frame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Caregiving burden
Time frame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Sense of guilt
Time frame: From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 / Nurse-led patients' education and Intervention 2 / Nurse-led patients' & caregivers' education in people with Heart Failure, run by Hellenic Mediterranean University at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Giakoumidakis, Associate Professor (00306973793489, kongiakoumidakis@hmu.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Failure Patients' Quality of Life (time frame: from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.