Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT04509856
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2020-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teach-Back Educational Method On Diabetes Knowledge Level
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes knowledge level (DKL)', 'timeFrame': '3 months', 'description': 'The DKL will be measured through a self-structured questionnaire containing 11 items. The questionnaire contains three answers: "yes," "no," or "I do not know." The right answer will be accepted as two points, the wrong answer as zero points, and the "I do not know" answer will be accepted as one point. The total scores ranges from 0-22. Higher scores of the questionnaire indicates that the higher DKL.'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': '3 months', 'description': 'Fasting blood glucose in mg/dl'}, {'measure': 'HbA1c', 'timeFrame': '3 months', 'description': 'HbA1c in %'}, {'measure': 'Blood pressure', 'timeFrame': '3 months', 'description': 'Blood pressure in mmHG'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes', 'education', 'teach-back'], 'conditions': ['Patient Empowerment']}, 'descriptionModule': {'briefSummary': 'It was aimed to research the effect of teach-back educational method on diabetes knowledge level and clinical parameters in type 2 diabetes patients undergoing insulin therapy. This is a randomized-controlled trial. Teach-back method will used for intervention group, routin diabetes education will used for control group. The primary outcome is diabetes knowledge levels (DKL), and secondary outcome is clinical patameters (fasting blood glucose, HbA1c, blood pressure). DKL and clinical parameters will measured and compared between two groups before and three months after the interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To have Type 2 Diabetes\n* To be over 18 years old\n* Not have any barriers in understanding and speaking Turkish\n* Who started insulin treatment for the first time\n\nExclusion Criteria:\n\n* Patients with a diagnosis of dementia\n* To have vision or hearing loss'}, 'identificationModule': {'nctId': 'NCT04509856', 'briefTitle': 'Teach-Back Educational Method On Diabetes Knowledge Level', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Impact Of Teach-Back Educational Method On Diabetes Knowledge Level And Clinical Parameters In Type 2 Diabetes Patients Undergoing Insulin Therapy', 'orgStudyIdInfo': {'id': 'YaseminC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Routine diabetes education will given to the patients included in the Control Group by a diabetes education nurse. The diabetes education nurse has been working for 10 years in the same center.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Intervention Group will take their diabetes education by teach-back educational strategy.', 'interventionNames': ['Behavioral: Teach-back educational method']}], 'interventions': [{'name': 'Teach-back educational method', 'type': 'BEHAVIORAL', 'description': "In the teach-back method, after teaching new information to the patient, the patients were asked to explain that new information in their own words. Then the patients' knowledge and the adequateness of their explanations were determined. The patient should repeat the instructions in their own words. In this way, the healthcare professional can evaluate how the patient understands the information. If the patient repeated the information correctly, the teach-back phase for that information was completed, and progression for new information was resumed. However, if there was a deficiency or error in the information, it was corrected and repeated by the healthcare professional.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25040', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Yasemin Cayir, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The clinical outcomes will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yasemin Cayir', 'investigatorAffiliation': 'Ataturk University'}}}}