Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 8:48 PM
Study NCT ID:
NCT06516705
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effectiveness of Multimedia Education on Hypoglycemic Management.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mayhuang@ntin.edu.tw', 'phone': '886-0956646992', 'title': 'Mei-Chuan Huang', 'organization': 'National Tainan Junior College of Nursing'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The time before education, the time after education, 3 month after education and 6 month after education.', 'eventGroups': [{'id': 'EG000', 'title': 'Multimedia Hypoglycemia Health Education', 'description': 'The multimedia educational content included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional Hypoglycemia Education', 'description': 'The verbal educational content provided by the health educators included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Score of Hypoglycemia Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimedia Hypoglycemia Health Education', 'description': 'The multimedia educational content included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.'}, {'id': 'OG001', 'title': 'Conventional Hypoglycemia Education', 'description': 'The verbal educational content provided by the health educators included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Hypoglycemia management knowledge scale to collect the score in Knowledge. The scale consists of eight true/false questions, with scores ranging from 0 to 8 points. Higher scores indicate a higher level of knowledge about hypoglycemia in patients.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Score of Hypoglycemia Self-care Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Multimedia Hypoglycemia Health Education', 'description': 'The multimedia educational content included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.'}, {'id': 'OG001', 'title': 'Conventional Hypoglycemia Education', 'description': 'The verbal educational content provided by the health educators included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Hypoglycemia self-care behavior scale to collect the score in Behavior. 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This scale consists of 13 items, rated on a 5-point Likert scale with a score range of 0 to 52 points. 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The scale consists of 13 items, rated on a 5-point Likert scale with a score range of 0 to 52 points. 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management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.\n\nHypoglycemia education: Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.'}], 'periods': [{'title': 'T1( Before Hypoglycemia Education)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'T2( After Hypoglycemia Education)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'T3 ( 3 Month After Education)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'No follow-up clinic visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'covid-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Refused to respond', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'T4 ( 6 Month After Education)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'No follow-up clinic visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'covid-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Refused to respond', 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'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '69.7', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '69.9', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-23', 'size': 344949, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-25T12:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2024-07-09', 'resultsFirstSubmitDate': '2024-08-04', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-18', 'studyFirstPostDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Score of Hypoglycemia Knowledge', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Hypoglycemia management knowledge scale to collect the score in Knowledge. The scale consists of eight true/false questions, with scores ranging from 0 to 8 points. Higher scores indicate a higher level of knowledge about hypoglycemia in patients.'}, {'measure': 'The Score of Hypoglycemia Self-care Behavior', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Hypoglycemia self-care behavior scale to collect the score in Behavior. The scale comprises 10 items, each rated on a 5-point Likert scale, with total scores ranging from 10 to 50. Higher scores indicate better self-care behaviors in managing hypoglycemia.'}, {'measure': 'Nursing Time', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Form Recorded for Health Education Time'}, {'measure': 'The Score of Education Satisfaction', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Education satisfaction scale to collect the score in education satisfaction. Items were rated on a 5-point Likert scale, with a score range of 1 to 5 points, for a total score range of 5 to 25 points.'}, {'measure': 'The Recurrence Rate of Hypoglycemic Events', 'timeFrame': 'Through study completion, an average of 6 months.', 'description': 'Questionnaire to assess the rate of hypoglycemic events.'}], 'secondaryOutcomes': [{'measure': 'The Score of Fear of Hypoglycemia', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Hypoglycemia fear scale to collect the score in fear of hypoglycemia. This scale consists of 13 items, rated on a 5-point Likert scale with a score range of 0 to 52 points. Higher scores indicate a greater degree of fear of hypoglycemia among patients.'}, {'measure': 'The Score of Social Support', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Social support scale to collect the score in social support. The scale consists of 13 items, rated on a 5-point Likert scale with a score range of 0 to 52 points. Higher scores indicate higher levels of social support.'}, {'measure': 'The Score of Quality of Life', 'timeFrame': 'Through study completion, an average of 6 months after education.', 'description': 'Quality of life scale to collect the score in quality of life. The scale consists of 28 items, each rated on a 5-point Likert scale, with scores for each domain converted to a total range of 16 to 80 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multimedia education', 'hypoglycemia', 'knowledge', 'self-care behavior', 'the recurrence rate of hypoglycemic events'], 'conditions': ['Type2diabetes', 'Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'The first phase of the research was to develop tools, including scales and multimedia, and the second phase was to carry out multimedia hypoglycemia education intervention measures. An experimental randomized controlled trial with a repeated measures design was conducted in second phase. Participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education. Structural questionnaires were used for data collection. The study was to investigate the effectiveness of multimedia hypoglycemia education compared to conventional hypoglycemia education on knowledge, self-care behavior, fear of hypoglycemia, social support, quality of life, nursing hours, education satisfaction, and the recurrence rate of hypoglycemic events among patients with type 2 diabetes.', 'detailedDescription': 'In the first phase, we created multimedia educational content on hypoglycemia and recruited 300 type 2 diabetes patients who had experienced hypoglycemic events from a medical center and a primary care clinic in southern Taiwan. The participants completed consent forms and questionnaires, and we conducted statistical analyses to develop and evaluate knowledge and behavior assessment tools. We obtained consent from 83 participants to enter the second phase, where they received hypoglycemia education and were then randomly assigned by computer to either the experimental group or the contrast group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetes and blood glucose levels below 70 mg/dL\n\nExclusion Criteria:\n\n* patients with cognitive impairment, those who are unable to perform activities of daily living and those with severe or unstable medical conditions.'}, 'identificationModule': {'nctId': 'NCT06516705', 'briefTitle': 'The Effectiveness of Multimedia Education on Hypoglycemic Management.', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Relationship Between Knowledge, Self-care Behaviors, Fear, Social Support and Quality of Life in Patients With Type 2 Diabetes, and the Effectiveness of Multimedia Education on Hypoglycemic Management.', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(II)-20180100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimedia hypoglycemia health education', 'description': 'The multimedia educational content included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.', 'interventionNames': ['Behavioral: Hypoglycemia education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional hypoglycemia education', 'description': 'The verbal educational content provided by the health educators included an introduction to blood glucose, symptoms and management of hypoglycemia (the 15-rule), prevention of hypoglycemia (diet and exercise), and medication therapy.', 'interventionNames': ['Behavioral: Hypoglycemia education']}], 'interventions': [{'name': 'Hypoglycemia education', 'type': 'BEHAVIORAL', 'description': 'Hypoglycemia education : incleded introduction to blood glucose, hypoglycemia symptoms and treatment (15-15 rule), prevention of hypoglycemia (diet and exercise), and medication treatment.', 'armGroupLabels': ['Conventional hypoglycemia education', 'Multimedia hypoglycemia health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}