Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-28 @ 2:54 PM
Study NCT ID:
NCT06961461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-assisted Quality Control Study of Multimodal Data in the Epidemiological Survey of Shanghai Nicheng Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'From enrollment to the end of questionnaire quality control at 8 weeks', 'description': 'changes in the efficiency and accuracy of quality control of data collected in large-scale epidemiological surveys with AI-assisted tool'}], 'secondaryOutcomes': [{'measure': 'Completeness and consistency', 'timeFrame': 'From enrollment to the end of questionnaire quality control at 8 weeks', 'description': 'AI-assisted quality control in questionnaire quality control improves the integrity and consistency of questionnaire data through automated keyword extraction and logical consistency checking.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quality Control', 'Cohort Studies']}, 'descriptionModule': {'briefSummary': 'This study is based on the Nicheng Cohort study. This study intends to analyze whether AI assistance can effectively improve the efficiency and accuracy of quality control of data collected in large-scale epidemiological surveys based on traditional quality control processes.', 'detailedDescription': 'This study randomly divided quality control personnel into an experimental group and a control group. The experimental group adopts AI assisted quality control: the AI system automatically transcribes the recorded text of the questionnaire, extracts keywords, analyzes the consistency of the Q\\&A logic, and generates quality control prompts. The quality control personnel will verify the question fragments according to the prompts and determine the qualification of the questionnaire; The control group relies entirely on manual quality control: the quality control personnel listen to the recording word by word, manually record the content, independently identify keyword omissions, logical contradictions, or terminology deviations, and ultimately determine whether the questionnaire is qualified. The core difference lies in the fact that the experimental group uses AI technology to accurately locate risk issues, reducing the burden of manual comprehensive screening, while the control group requires full manual review without targeted support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Questionnaires in the Nicheng cohort', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be proficient in using computers;\n2. The person responsible for questionnaire quality control needs to have good dialect recognition ability;\n3. Have a basic understanding or high acceptance of AI-assisted tools, and be able to adapt to the learning and application of new technologies\n4. Be able to participate in the research throughout the process, abide by the research process, receive training, and be willing to complete quality control tasks as required.\n\nExclusion Criteria:\n\n1. The person responsible for questionnaire quality control cannot understand or recognize Shanghai Nanhui dialect proficiently;\n2. Unfamiliar with AI-assisted tools and difficult to accept technical operations;\n3. Unable to participate in the research, receive training or complete the specified tasks due to other work or academic reasons;'}, 'identificationModule': {'nctId': 'NCT06961461', 'briefTitle': 'AI-assisted Quality Control Study of Multimodal Data in the Epidemiological Survey of Shanghai Nicheng Cohort Study', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 6th People's Hospital"}, 'officialTitle': 'AI-assisted Quality Control Study of Multimodal Data in the Epidemiological Survey of Shanghai Nicheng Cohort Study', 'orgStudyIdInfo': {'id': '2025-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Manual quality control', 'description': 'The questionnaire content was checked by manually listening back to the recordings and errors were recorded manually'}, {'label': 'Use AI tools to conduct quality control', 'description': 'Quality control personnel use an integrated AI-assisted system to perform quality control on epidemiological survey data. The AI system automatically transcribes audio and analyzes data quality,. Quality control personnel conduct reviews based on AI prompts.', 'interventionNames': ['Other: AI-assisted quality control tool']}], 'interventions': [{'name': 'AI-assisted quality control tool', 'type': 'OTHER', 'description': 'In this study, quality control personnel will be randomly divided into an experimental group and a control group, and will use artificial intelligence-assisted quality control and manual quality control to conduct quality control on the data collected from the epidemiological survey.\n\nExperimental group: Quality control personnel will use the AI system to perform quality control on the questionnaire recordings.\n\nControl group: The questionnaire content was checked by manually listening back to the recordings and errors were recorded manually.', 'armGroupLabels': ['Use AI tools to conduct quality control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 6th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Li Huating', 'investigatorAffiliation': "Shanghai 6th People's Hospital"}}}}