Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-02 @ 2:02 AM
Study NCT ID:
NCT04497259
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Bariatric Surgery by Teleconsultations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019114', 'term': 'Remote Consultation'}], 'ancestors': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite score research', 'timeFrame': 'month 12', 'description': 'Look for the composite follow-up quality score taking into account weighting results, co-morbidities, absence of complications and skill acquisition.'}], 'secondaryOutcomes': [{'measure': 'Coefficient evaluation', 'timeFrame': 'month 12', 'description': "Coefficient of variation and Cronbach's coefficient assessing the quality of the composite follow-up quality score"}, {'measure': 'Consultation measure', 'timeFrame': 'month 6 and 9', 'description': 'the time of a teleconsultation and a face-to-face consultation, by an objective measurement of this time at 6 and 9 months postoperatively'}, {'measure': 'Composite distribution', 'timeFrame': 'month 12', 'description': 'the distribution of each of the components of the Composite Follow-up Quality Score in the two arms of the study'}, {'measure': 'Consultation feeling', 'timeFrame': 'Month 6 and 9', 'description': 'satisfaction and constraints felt with regard to teleconsultations, by scores measured at teleconsultations and consultation at 6 and 9 months post-operatively'}, {'measure': 'Consultation feasability', 'timeFrame': 'month 6 and 9', 'description': 'the feasibility of teleconsultation and consultation with scores measured at 6 and 9 months post-operatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric surgery', 'follow-up', 'tele-evaluations', 'e-medicine'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing teleevaluations and teleconsultations to classical follow, aiming to prove that the quality of the follow-up is maintained and the patient-experience is improved, at a lower cost in people living far from the reference centre, this pilot study aims at describing the distribution of the collected criteria.', 'detailedDescription': 'An organised follow-up is required after bariatric surgery, but 50% of patients are lost to follow-up after 2 years. This follow-up requires about 5 multi-professional evaluations during the first year. This can be cumbersome in patients living far from the reference centre and who may perceive the necessary time, cost and lost of income, and constraints as imbalanced. Teleevaluations and teleconsultations may solve this issue by replacing some of the classical evaluations (at 6 and 9 months). An RCT would be necessary, and a pilot study is proposed to describe the distribution of the judgment criteria.\n\nThis pilot study aims at describing all the parameters necessary to build an RCT, and involves the randomisation of operated patients recruited 3 months after surgery, in to groups. One will have the classical follow-up (venue and consultations at 6 and 9 months) the over will have teleevaluations and teleconsultations ; the parameters will be described at 12 months. The teleevaluation is either proposed as usual (a file is sent by secure mail) or by chatbot interaction. The consultation and the teleconsultation are based on the standard of care scenario.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults having had bariatric surgery 3 months before\n* able to use an internet tool of chatbot and skype-like secured connection\n* adult under 60 years old\n* free inform and sign consent\n* living more than 50km from Toulouse\n* persons with social security\n\nExclusion Criteria:\n\n* complications at the 3rd month post-surgery requiring specific care\n* insufficient internet connection\n* minor\n* pregnant women\n* protected adults\n* people in emergency\n* people unable to give consent'}, 'identificationModule': {'nctId': 'NCT04497259', 'acronym': 'TELECHIRO', 'briefTitle': 'Follow-up of Bariatric Surgery by Teleconsultations', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.', 'orgStudyIdInfo': {'id': 'RC31/19/0128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Patients in the teleconsultation arm will benefit from a tele-evaluation (a questionnaire filled through a chatbot link) and teleconsultation (skype-like connection) at 6 and 9 months after surgery.', 'interventionNames': ['Other: Teleevaluation', 'Other: Teleconsultation']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Patients in the consultation arm will benefit from a tele-evaluation (a questionnaire filled at home after the file was sent by secured mail) and a classical face to face consultation at 6 and 9 months after surgery.', 'interventionNames': ['Other: Teleevaluation', 'Other: Classical consultation']}], 'interventions': [{'name': 'Teleevaluation', 'type': 'OTHER', 'description': 'Patients will answer to a questionnaire filled through a chatbot link', 'armGroupLabels': ['Control', 'Interventional']}, {'name': 'Teleconsultation', 'type': 'OTHER', 'description': 'A teleconsultation (skype-like connection) at 6 and 9 months after surgery', 'armGroupLabels': ['Interventional']}, {'name': 'Classical consultation', 'type': 'OTHER', 'description': 'Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'state': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick Ritz', 'role': 'CONTACT', 'email': 'ritz.p@chu-toulouse.fr', 'phone': '0561323048', 'phoneExt': '+33'}, {'name': 'Emilie MONTASTIER', 'role': 'CONTACT'}, {'name': 'Ana ESTRADE', 'role': 'CONTACT'}, {'name': 'Leila BOULANOUAR', 'role': 'CONTACT'}, {'name': 'Monelle BERTRAND', 'role': 'CONTACT'}], 'facility': 'Ritz', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Patrick RITZ, MD', 'role': 'CONTACT', 'email': 'ritz.p@chu-toulouse.fr', 'phone': '05 61 32 30 48', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Patrick RITZ, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}