Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 12:58 AM
Study NCT ID:
NCT06852794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-28
First Post:
2025-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
USE OF ARTIFICIAL INTELLIGENCE IN A PULMONARY FIBROSIS CLINIC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-01-30', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of VAS scores of clarity of the message in questionnaires administered at T1 and at T2', 'timeFrame': '15 days'}, {'measure': 'Variation of VAS scores of empathy conveyed in questionnaires administered at T1 and at T2', 'timeFrame': '15 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of answers recognised correctly as answers provided by AI among the total of answers flagged as provided by AI by study subjects', 'timeFrame': '1 day'}, {'measure': "Stratify the results by patients' demographic characteristics and past experiences with artificial intelligence systems.", 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence'], 'conditions': ['Interstitial Disease']}, 'descriptionModule': {'briefSummary': 'The present study aims to evaluate the usefulness of artificial intelligence (AI) in the back-office of an ILD (Interstitial Lung Disease) clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients attending ILD clinic of the IRCCS Fondazione Policlinico A. Gemelli.\n\nExclusion Criteria:\n\n* Patients unable or unwilling to sign the informed consent\n* Patients who are senders of one of the emails chosen for the questionnaire\n* Patients with manifest inability to fill out the questionnaire'}, 'identificationModule': {'nctId': 'NCT06852794', 'acronym': 'LLM-ILD', 'briefTitle': 'USE OF ARTIFICIAL INTELLIGENCE IN A PULMONARY FIBROSIS CLINIC', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'USE OF ARTIFICIAL INTELLIGENCE IN THE BACK-OFFICE OF A SPECIALIZED MEDICAL CLINIC FOR PULMONARY FIBROSIS (LLM-ILD)', 'orgStudyIdInfo': {'id': '7002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients attending ILD clinic', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'The patients will receive questionnaires. The enrolled patients will be asked to provide feedback on the answers they read.', 'armGroupLabels': ['Patients attending ILD clinic']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Luca Richeldi, MD', 'role': 'CONTACT', 'email': 'luca.richeldi@policlinicogemelli.it', 'phone': '+390630157857'}, {'name': 'Diana Verdirosi, Sc', 'role': 'CONTACT', 'email': 'diana.verdirosi@policlinicogemelli.it', 'phone': '+390630157724'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'RICHELDI LUCA', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}