Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT06694467
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2024-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2024-11-15', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated hemoglobin level', 'timeFrame': '6 months', 'description': 'Serum glycosylated hemoglobin level was measured as a baseline, then 6 months after the intervention, to measure the mean difference between the two readings.'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Pediatric Quality of Life-Diabetes Module was used. The twenty-eight items in this multidimensional tool are categorized into five domains: treatment obstacles (four items), treatment adherence (seven items), concern (three items), and diabetic symptoms (eleven items). For teenage self-report, a five-point Likert scale was employed. The total number of questions divided by the total number of answers is how scale scores are calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Quality of life'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '39658013', 'type': 'DERIVED', 'citation': 'Alzawahreh S, Ozturk C. Improving Self-Efficacy, Quality of Life, and Glycemic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial for the Evaluation of the Family-Centered Empowerment Model. JMIR Form Res. 2024 Dec 10;8:e64463. doi: 10.2196/64463.'}]}, 'descriptionModule': {'briefSummary': 'Empowerment in healthcare, particularly in the context of chronic illness management such as diabetes, entails equipping patients with knowledge, expertise, and self-assurance to proactively oversee their health and make well-informed choices. This encompasses comprehensive strategies that target psychological, social, and lifestyle elements with the goal of enhancing self-confidence and health results. The objective of this research is to evaluate how the Family-Centered Empowerment Model affects the clinical and psychological outcomes of adolescents with Type 1 Diabetes, with an emphasis on increases in quality of life, self-efficacy, and glycosylated hemoglobin (HbA1c) levels.', 'detailedDescription': 'Diabetes mellitus (DM) is a prevalent and increasingly acknowledged medical disorder that affects individuals worldwide. It is a metabolic condition marked by elevated blood glucose levels that can cause serious side effects like renal failure, heart disease, blindness, and even amputations. To provide a better understanding of the Family-Centered Empowerment Model intervention applied in this work, the components and delivery modes are described in more detail below. Furthermore, a figure or a table suggested at this part could help to present this information more shortly. Details about the intervention The Family-Centered Empowerment Model intervention aimed to help engage the adolescent, an individual with type 1 DM, and his/her family in the self management process. The purpose of this study was to improve coping skills with type 1 DM population by increasing teamwork between adolescents and their members of their household.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with type 1 diabetes, ages 12 to 18 years\n* Patients who had not taken part in any professional diabetes education program within a month of receiving their diagnosis\n* Patients who had been diagnosed at least six months earlier to the commencement of the study.\n\nExclusion Criteria:\n\n* Adolescents who had severe long-term diseases\n* Patients newly diagnosed type 1 diabetes.\n* those who were enrolled in a diabetes education program one month or less prior to the commencement of the study.'}, 'identificationModule': {'nctId': 'NCT06694467', 'briefTitle': 'Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Near East University, Turkey'}, 'officialTitle': 'Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes: An Experimental Evaluation of the Family Centered Empowerment Model', 'orgStudyIdInfo': {'id': 'NEU/2023/110-1681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'An official diabetes education program and family empowerment model where employed, designed to provide people with diabetes and their families the information and abilities they need to manage their condition effectively. Types of diabetes, blood sugar control, self-monitoring methods, nutrition, meal planning, physical activity recommendations, medication management, and problem-solving approaches are all included in these programs', 'interventionNames': ['Behavioral: Education program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients diagnosed with type 1 diabetes mellitus for six months or more and had not attended any form of structured diabetes education including hospital-based classes or community group diabetes education classes for the preceding month of the study. These parameters were adopted to ensure that study takes place in a controlled environment and targets the aspects of intervention of study.'}], 'interventions': [{'name': 'Education program', 'type': 'BEHAVIORAL', 'otherNames': ['Diabetes education program'], 'description': 'An official diabetes education program designed to provide people with diabetes and their families the information and abilities they need to manage their condition effectively. Diabetes kinds, blood sugar control, self-monitoring methods, nutrition, meal planning, physical activity recommendations, medication management, and problem-solving approaches are all included in these programs. Additionally, they offer psychological assistance to help people manage the emotional challenges of having diabetes.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nicosia', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The study protocol, methodology, results, and the accompanying data will be published online after peer review process by the scientific journal to which it will be submitted.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Near East University, Turkey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, MSc', 'investigatorFullName': 'Salah Alzawahreh', 'investigatorAffiliation': 'Near East University, Turkey'}}}}