<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04497259</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/19/0128</org_study_id>
    <nct_id>NCT04497259</nct_id>
  </id_info>
  <brief_title>Follow-up of Bariatric Surgery by Teleconsultations</brief_title>
  <acronym>TELECHIRO</acronym>
  <official_title>Using Tele-evaluation and Teleconsultation Instead of Classical Consultation for the Follow-up of Obese Patients After Bariatric Surgery : a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An organised follow-up is required after bariatric surgery, but 50% of patients are lost to&#xD;
      follow-up after 2 years. To design a large randomized clinical trial (RCT) comparing&#xD;
      teleevaluations and teleconsultations to classical follow, aiming to prove that the quality&#xD;
      of the follow-up is maintained and the patient-experience is improved, at a lower cost in&#xD;
      people living far from the reference centre, this pilot study aims at describing the&#xD;
      distribution of the collected criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An organised follow-up is required after bariatric surgery, but 50% of patients are lost to&#xD;
      follow-up after 2 years. This follow-up requires about 5 multi-professional evaluations&#xD;
      during the first year. This can be cumbersome in patients living far from the reference&#xD;
      centre and who may perceive the necessary time, cost and lost of income, and constraints as&#xD;
      imbalanced. Teleevaluations and teleconsultations may solve this issue by replacing some of&#xD;
      the classical evaluations (at 6 and 9 months). An RCT would be necessary, and a pilot study&#xD;
      is proposed to describe the distribution of the judgment criteria.&#xD;
&#xD;
      This pilot study aims at describing all the parameters necessary to build an RCT, and&#xD;
      involves the randomisation of operated patients recruited 3 months after surgery, in to&#xD;
      groups. One will have the classical follow-up (venue and consultations at 6 and 9 months) the&#xD;
      over will have teleevaluations and teleconsultations ; the parameters will be described at 12&#xD;
      months. The teleevaluation is either proposed as usual (a file is sent by secure mail) or by&#xD;
      chatbot interaction. The consultation and the teleconsultation are based on the standard of&#xD;
      care scenario.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 26, 2023</start_date>
  <completion_date type="Anticipated">February 26, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 26, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite score research</measure>
    <time_frame>month 12</time_frame>
    <description>Look for the composite follow-up quality score taking into account weighting results, co-morbidities, absence of complications and skill acquisition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Coefficient evaluation</measure>
    <time_frame>month 12</time_frame>
    <description>Coefficient of variation and Cronbach's coefficient assessing the quality of the composite follow-up quality score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultation measure</measure>
    <time_frame>month 6 and 9</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite distribution</measure>
    <time_frame>month 12</time_frame>
    <description>the distribution of each of the components of the Composite Follow-up Quality Score in the two arms of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultation feeling</measure>
    <time_frame>Month 6 and 9</time_frame>
    <description>satisfaction and constraints felt with regard to teleconsultations, by scores measured at teleconsultations and consultation at 6 and 9 months post-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultation feasability</measure>
    <time_frame>month 6 and 9</time_frame>
    <description>the feasibility of teleconsultation and consultation with scores measured at 6 and 9 months post-operatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Teleevaluation</intervention_name>
    <description>Patients will answer to a questionnaire filled through a chatbot link</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Teleconsultation</intervention_name>
    <description>A teleconsultation (skype-like connection) at 6 and 9 months after surgery</description>
    <arm_group_label>Interventional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Classical consultation</intervention_name>
    <description>Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults having had bariatric surgery 3 months before&#xD;
&#xD;
          -  able to use an internet tool of chatbot and skype-like secured connection&#xD;
&#xD;
          -  adult under 60 years old&#xD;
&#xD;
          -  free inform and sign consent&#xD;
&#xD;
          -  living more than 50km from Toulouse&#xD;
&#xD;
          -  persons with social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complications at the 3rd month post-surgery requiring specific care&#xD;
&#xD;
          -  insufficient internet connection&#xD;
&#xD;
          -  minor&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  protected adults&#xD;
&#xD;
          -  people in emergency&#xD;
&#xD;
          -  people unable to give consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick RITZ, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick RITZ, MD</last_name>
    <phone>05 61 32 30 48</phone>
    <phone_ext>+33</phone_ext>
    <email>ritz.p@chu-toulouse.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ritz</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Ritz</last_name>
      <phone>0561323048</phone>
      <phone_ext>+33</phone_ext>
      <email>ritz.p@chu-toulouse.fr</email>
    </contact>
    <investigator>
      <last_name>Emilie MONTASTIER</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ana ESTRADE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leila BOULANOUAR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Monelle BERTRAND</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 21, 2023</last_update_submitted>
  <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bariatric surgery</keyword>
  <keyword>follow-up</keyword>
  <keyword>tele-evaluations</keyword>
  <keyword>e-medicine</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04497259
org study id: RC31/19/0128
nct id: NCT04497259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.

      This 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Composite score research
time frame: month 12
description: Look for the composite follow-up quality score taking into account weighting results, co-morbidities, absence of complications and skill acquisition.
measure: Coefficient evaluation
time frame: month 12
description: Coefficient of variation and Cronbach's coefficient assessing the quality of the composite follow-up quality score
measure: Consultation measure
time frame: 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
time frame: 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
time frame: 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
time frame: month 6 and 9
description: the feasibility of teleconsultation and consultation with scores measured at 6 and 9 months post-operatively
arm group label: Interventional
arm group type: Experimental
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.
arm group label: Control
arm group type: Experimental
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.
intervention type: Other
intervention name: Teleevaluation
description: Patients will answer to a questionnaire filled through a chatbot link
arm group label: Control
arm group label: Interventional
intervention type: Other
intervention name: Teleconsultation
description: A teleconsultation (skype-like connection) at 6 and 9 months after surgery
arm group label: Interventional
intervention type: Other
intervention name: Classical consultation
description: Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Patrick RITZ, Md
role: Principal Investigator
affiliation: University Hospital, Toulouse
last name: Patrick RITZ, MD
phone: 05 61 32 30 48
phone ext: +33
email: ritz.p@chu-toulouse.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor