Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT04608058
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-10-27', 'studyFirstSubmitQcDate': '2020-10-27', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Self-management behavior', 'timeFrame': '3 months', 'description': 'Self-Management of TID in Adolescence (SMOD-A) questionnaire which includes 48 items in 5 domains; cooperation with Parents, Diabetes care activities, Diabetes Problem-Solving, Diabetes Communication, and Goal in Diabetes. Each item is scored on a 4-point Likert scale ranging from 0 (never) to 3 (always). Higher scores are associated with better self-management behaviors.'}], 'secondaryOutcomes': [{'measure': 'Change in Glycated hemoglobin A1c', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Self-Management']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the effects of digital storytelling on the Self-Management behavior of adolescents with type 1 diabetes (TID).', 'detailedDescription': "In this single-blind randomized controlled trial, 60 eligible adolescents with TID were selected based on a convenient sampling method. Next, the participants were randomly allocated into two parallel groups: intervention (training with digital storytelling method, n=30) or control (training with conventional) n=30) groups. Before and three months after the intervention the patients' levels of self-management behaviors according to Self-Management of TID amongst adolescents (SMOD-A); in addition to the Glycated Hemoglobin test (HbA1c) were measured."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescents with TID\n* using medication (insulin)\n* willing to participate in the study and complete the informed consent\n* having a basic knowledge of working with computers\n* ability to communicate on the telephone.\n\nExclusion Criteria:\n\n* physical or mental disabilities\n* take anti-anxiety or antidepressant medication'}, 'identificationModule': {'nctId': 'NCT04608058', 'briefTitle': 'Promoting Self-management Behaviors in Adolescents With Type 1 Diabetes, Using Digital Storytelling', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Comparison of Self-management Behaviors Education Through Digital Storytelling Method and Conventional Method in Adolescents With Type 1 Diabetes Referred to Diabetes Clinic in Hospitals Affiliated to Shiraz University of Medical Sciences.', 'orgStudyIdInfo': {'id': '1398.244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'At first, participants\' demographic data, the levels of "self-management", and "HbA1c "were documented at the commencement of the study. Then, asynchronous Diabetes self-management training, using digital storytelling was made available to this group. Post-test data were collected 3 months after the pretest.', 'interventionNames': ['Behavioral: Digital storytelling training']}, {'type': 'EXPERIMENTAL', 'label': 'No Intervention', 'description': 'At first, participants\' demographic data, the levels of "self-management", and "HbA1c "were documented at the commencement of the study. Then, the control group received the clinics\' routine training. Post-test data were collected 3 months after the pretest.', 'interventionNames': ['Behavioral: Routine training']}], 'interventions': [{'name': 'Digital storytelling training', 'type': 'BEHAVIORAL', 'description': 'The digital content in this study is called "Diabetes and Bumblebee". It features 35 minutes of animation that provides children with a brief description of the disease, its symptoms and complications, treatment methods, the type of insulin, how to preserve insulin, the importance of nutrition and exercise in treating diabetes as well as efficient communication and collaboration with parents and healthcare providers. Exciting and interactive animations were used to depict the daily life of a adolescence with diabetes.', 'armGroupLabels': ['Intervention']}, {'name': 'Routine training', 'type': 'BEHAVIORAL', 'description': "The control group received the clinics' routine training include face to face class education.", 'armGroupLabels': ['No Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Shiraz University of Medical Sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'overallOfficials': [{'name': 'Nahid zarifsanaiey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'associate Professor, Virtual school, Shiraz University of Medical Sciences, Shiraz, Iran.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nahid Zarifsanaiey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nahid Zarifsanaiey', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}