Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 2:00 PM
Study NCT ID:
NCT04017351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-20
First Post:
2019-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Assistant for Plastic Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of phone calls', 'timeFrame': '12 months', 'description': 'The total number of phone calls from subjects'}, {'measure': 'Duration of phone call', 'timeFrame': '12 months', 'description': 'Length of phone calls from subjects. Measured in minutes'}, {'measure': 'Nature of phone call', 'timeFrame': '12 months', 'description': 'The total number of phone calls related to the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plastic', 'Virtual Assistant'], 'conditions': ['Surgery']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying determine the long term impact when patients have access to the artificial intelligence virtual assistant (AIVA) as a complimentary resource.', 'detailedDescription': 'Eligible subjects will be randomized into to two groups. One group of subjects will be given access to the AIVA will be instructed to ask, at home, questions regarding the planned surgery to the AIVA application on their mobile phone. The other group will be instructed to call to the Standard of Care call center with questions related to their treatments. Researchers will follow up with all subjects from both groups for a 1 year amount of time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects above 18 years old\n* Able to use applications on mobile phones and consent to participate\n* Adult subjects in the Plastic Surgery outpatient clinic of Mayo Clinic Florida\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04017351', 'briefTitle': 'Virtual Assistant for Plastic Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Virtual Assistant for Plastic Surgery Patients - Impact on the Clerical Burden, Resource Utilization, Patient and Provider Satisfaction, and Patient Surgical Outcomes.', 'orgStudyIdInfo': {'id': '19-001980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with virtual assistance', 'description': 'Subjects receiving current standard of care for a surgical procedure within the department of plastic surgery will have access to artificial intelligence virtual assistance (AIVA)', 'interventionNames': ['Other: Artificial Intelligence Virtual Assistant']}, {'type': 'NO_INTERVENTION', 'label': 'Subjects without virtual assistance', 'description': 'Subjects receiving current standard of care for a surgical procedure within the department of plastic surgery'}], 'interventions': [{'name': 'Artificial Intelligence Virtual Assistant', 'type': 'OTHER', 'otherNames': ['AIVA'], 'description': 'Virtual assistance application for subjects to ask questions and get information regarding planned surgery', 'armGroupLabels': ['Subjects with virtual assistance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Antonio Forte, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Antonio Forte, MD, PhD', 'role': 'CONTACT', 'email': 'forte.antonio@mayo.edu', 'phone': '904-953-2073'}, {'name': 'Mauricia Buchanan, RN', 'role': 'CONTACT', 'email': 'buchanan.mauricia@mayo.edu', 'phone': '904-953-2073'}], 'overallOfficials': [{'name': 'Antonio Forte, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Antonio J. Forte', 'investigatorAffiliation': 'Mayo Clinic'}}}}