Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04754620
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-12', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-12', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction score with the video visits', 'timeFrame': 'the day after the visit', 'description': 'Measurement of satisfaction with RAND Visit Specific Questionnaire (VSQ9),Minimum score "0" poor and maximum score is "5" represents excellent,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of smartphone video-based telehealth in the management of Crohn's disease patients", 'detailedDescription': 'Patients were examined by two gastroenterologists (HY, AED) either at a video conference based visit or face to face visit in outpatients clinics. We used the WhatsApp business application.The online visit notion was the same as traditional face-to-face visit except physical examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study group included patients with documented Crohn's disease, based on clinical, endoscopic, and histologic findings\n* Patient between 18-80 years old\n* Participants who have been receiving treatment for more than six months\n\nExclusion Criteria:\n\n* Patients were excluded from the study if they had no internet connection\n* Unable to use smartphones because of blindness, deafness, or mental disorders"}, 'identificationModule': {'nctId': 'NCT04754620', 'briefTitle': "Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs", 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': "Implementation and Evaluation of Smartphone-Based Videoconferance Telehealth for Patients With Crohn's Disease", 'orgStudyIdInfo': {'id': 'KouTeleH001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard face to face visit', 'description': 'This group will receive a traditional outpatient visit'}, {'type': 'EXPERIMENTAL', 'label': 'Online visit', 'description': 'This group will receive a smartphone-based real-time video conference visit', 'interventionNames': ['Other: real time online video visit']}], 'interventions': [{'name': 'real time online video visit', 'type': 'OTHER', 'description': 'Participants have received an online visit by a smartphone application', 'armGroupLabels': ['Online visit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41001', 'city': 'İzmit', 'state': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Medical Faculty Hospital', 'geoPoint': {'lat': 40.76499, 'lon': 29.92928}}], 'overallOfficials': [{'name': 'göktuğ şirin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': 'Data will be available for one year after the study completed', 'ipdSharing': 'YES', 'accessCriteria': 'Public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hasan Yılmaz', 'investigatorAffiliation': 'Kocaeli University'}}}}