[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557996":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":30,"armGroups":38,"interventions":54,"overallOfficials":30,"centralContacts":63,"locations":73,"responsibleParty":92,"collaborators":30,"id":96,"slug":30,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":30,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":30,"enrollmentInfo":104,"targetDuration":30,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":88,"whyStopped":30,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Hellenic Mediterranean University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":30},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"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.","from date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.",{"measure":14,"description":15,"timeFrame":12},"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).",{"measure":17,"description":18,"timeFrame":12},"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.",[20,24,27],{"measure":21,"description":22,"timeFrame":23},"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).","From date of first communication with patient until the date of documented progression, assessed up estimate to 24 months.",{"measure":25,"description":26,"timeFrame":23},"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.",{"measure":28,"description":29,"timeFrame":23},"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).",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"RANDOMIZED","SEQUENTIAL","SUPPORTIVE_CARE",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE","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.\n\nPurpose: 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.\n\nMethodology: 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.\n\nExpected 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.",[39,43,49],{"label":40,"type":41,"description":42,"interventionNames":30},"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",{"label":44,"type":45,"description":46,"interventionNames":47},"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",[48],"Other: Intervention 1 \u002F Nurse-led patients' education",{"label":50,"type":45,"description":51,"interventionNames":52},"Intervention 2 - Patients' and caregivers' education","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",[48,53],"Other: Intervention 2 \u002F Nurse-led patients' & caregivers' education",[55,59],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":30},"Intervention 1 \u002F Nurse-led patients' education","nurse-led education through oral sessions, educational materials, and regular phone calls",[44,50],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":30},"Intervention 2 \u002F Nurse-led patients' & caregivers' education","nurse-led education while caregivers also undergo training through oral sessions, phone calls, and appropriately designed educational materials",[50],[64,69],{"name":65,"role":66,"phone":67,"phoneExt":30,"email":68},"Konstantinos Giakoumidakis, Associate Professor","CONTACT","00306973793489","kongiakoumidakis@hmu.gr",{"name":70,"role":66,"phone":71,"phoneExt":30,"email":72},"Elefteria Markaki, PhD candidate","00306944582422","elefmarkaki@hmu.gr",[74,87],{"facility":5,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":30},"COMPLETED","Heraklion","Crete","71410","Greece","GR",{"type":82,"coordinates":83},"Point",[84,85],25.14341,35.32787,{"lat":85,"lon":84},{"facility":5,"status":88,"city":76,"state":30,"zip":30,"country":79,"countryCode":80,"cosmosGeoPoint":89,"geoPoint":91,"contacts":30},"RECRUITING",{"type":82,"coordinates":90},[84,85],{"lat":85,"lon":84},{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Konstantinos Giakoumidakis","Associate Professor in Clinical Nursing - Chronic Diseases Management","100557996",false,"NCT06545370","Nurse-led Education on Patients With Chronic Heart Failure and Their Informal Caregivers","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","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients recently hospitalized due to the disease\n* Patients and caregivers who are literate in Greek\n* Patients and caregivers who provide written informed consent for their participation in the study\n* Patients diagnosed with heart failure for at least 6 months\n* Caregivers who have been involved in the care of the patients for at least 6 months\n* Patients taking medication according to the guidelines of the European Society of Cardiology\n\nExclusion Criteria:\n\n* History of psychiatric disease, recent history of alcohol or\u002Fand drug abuse, dementia, and Alzheimer\\'s disease (for patients and caregivers)\n* Absence of an informal caregiver according to their statement","ALL","18 Years",{"count":105,"type":106},280,"ESTIMATED","INTERVENTIONAL",[109],"NA","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.",[112],"Heart Failure",[114,115,116,117],"Heart failure","informal caregivers","patient outcomes","nurse-led education","2025-09-19",{"date":120,"type":121},"2025-09-24","ACTUAL",{"date":123,"type":121},"2024-09-01",{"date":125,"type":106},"2027-09-01",{"name":5,"class":6},2]