Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-04 @ 10:11 AM
Study NCT ID:
NCT07140250
Status:
COMPLETED
Last Update Posted:
2025-08-24
First Post:
2025-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using ChatGPT to Help Guide Treatment for Sinus and Nasal Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012852', 'term': 'Sinusitis'}, {'id': 'D015508', 'term': 'Nasal Obstruction'}, {'id': 'D012220', 'term': 'Rhinitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-08-18', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional Conflict Scale (DCS) score', 'timeFrame': 'Immediate - Following completion of education using AI vs traditional education', 'description': 'Change in Decisional Conflict Scale (DCS) score'}], 'secondaryOutcomes': [{'measure': 'System usability scale (SUS) scores', 'timeFrame': 'Immediate following education'}, {'measure': 'Score on treatment-related knowledge questionnaire (MCQ)', 'timeFrame': 'Immediate following education'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sinusitis', 'shared decision making', 'rhinitis', 'chatGPT', 'nasal obstruction'], 'conditions': ['Sinusitis', 'Nasal Obstruction', 'Rhinitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether ChatGPT can improve shared decision-making by increasing treatment-related knowledge and reducing decisional conflict in adult patients with chronic rhinosinusitis (CRS) or nasal obstruction who have been deemed candidates for surgery.\n\nThe main questions it aims to answer are:\n\n* Does ChatGPT improve patient understanding of CRS/nasal obstruction treatment options compared to widely utilized web searches?\n* Does ChatGPT reduce decisional conflict regarding surgical versus medical management compared to traditional search engine? Researchers will compare a group using Google (standard internet search with AI turned off) after standard counseling to a group using ChatGPT after standard counseling to see if ChatGPT leads to higher knowledge scores, lower decisional conflict scores, and higher satisfaction with the information platform.\n\nParticipants will:\n\n* Complete baseline surveys assessing demographics, treatment-related knowledge, and decisional conflict\n* Be randomized to use either Google or ChatGPT to research their surgery for 10 minutes after standard in-office counseling\n* Complete follow-up surveys assessing knowledge, decisional conflict, and satisfaction with the information source\n* Allow the research team to review their medical record for relevant clinical history and disease-specific quality-of-life scores (SNOT-22)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (18 years or older) UC San Diego Health System Rhinology patients\n* Diagnosis of chronic rhinosinusitis and/or nasal obstruction based on clinical criteria or radiologic evidence\n* Planning to pursue surgical intervention for CRS or nasal obstruction\n* Ability to complete online survey in English or Spanish\n\nExclusion Criteria:\n\n* Unable to complete survey assessments online via REDCap\n* Under the age of 18 years\n* Vulnerable patient populations such as those who are pregnant and institutionalized individuals\n* Patients with benign and malignant tumors'}, 'identificationModule': {'nctId': 'NCT07140250', 'briefTitle': 'Using ChatGPT to Help Guide Treatment for Sinus and Nasal Problems', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Shared Decision-Making With ChatGPT for Patients With Sinusitis and Nasal Obstruction', 'orgStudyIdInfo': {'id': '810119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Shared Decision Making on Sinusitis Treatment Facilitated by ChatGPT', 'description': 'Shared decision making (SDM) about sinusitis treatment will be facilitated by ChatGPT through participant driven question and answers using AI support via ChatGPT', 'interventionNames': ['Other: Education with AI Technology']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Shared Decision Making on Sinusitis Treatment Facilitated by Google', 'description': 'Shared decision making (SDM) about sinusitis treatment will be facilitated by traditional internet search engines (Google) with AI mode off. Participate education on sinusitis treatment will be driven by traditional internet searches', 'interventionNames': ['Other: Education using Traditional Internet Search Engines']}], 'interventions': [{'name': 'Education with AI Technology', 'type': 'OTHER', 'description': 'Shared decision making (SDM) about sinusitis treatment will be facilitated by AI technology via ChatGPT', 'armGroupLabels': ['Shared Decision Making on Sinusitis Treatment Facilitated by ChatGPT']}, {'name': 'Education using Traditional Internet Search Engines', 'type': 'OTHER', 'description': 'Participant Education in Sinusitis using Traditional Internet Search Engines through Google', 'armGroupLabels': ['Shared Decision Making on Sinusitis Treatment Facilitated by Google']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carol Yan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Otolaryngology', 'investigatorFullName': 'Carol Yan', 'investigatorAffiliation': 'University of California, San Diego'}}}}