<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/NCT04407663</url>
  </required_header>
  <id_info>
    <org_study_id>Telemedicine</org_study_id>
    <nct_id>NCT04407663</nct_id>
  </id_info>
  <brief_title>Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near</brief_title>
  <official_title>Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near. Brief Correspondence on a Single Center Experience. Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bariatric patients represent a peculiar and frail subset of subjects, constantly increasing.&#xD;
      During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and&#xD;
      non-oncological activity, the access to healthcare services was severely limited, according&#xD;
      to the International Federation for the Surgery of Obesity and Metabolic Disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The constant and strict follow-up is mandatory in this special subset of patients. Therefore,&#xD;
      starting from the telemedicine experience in different medical fields, in our bariatric&#xD;
      surgery division we designed and started a dedicated project to follow-up obese patients&#xD;
      using remote counselling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2020</start_date>
  <completion_date type="Actual">May 4, 2020</completion_date>
  <primary_completion_date type="Actual">May 4, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients</measure>
    <time_frame>2 months</time_frame>
    <description>Telemedicine to follow-up and identify sing or symptom of alarm in patient undergoing bariatric surgery or in established bariatric patients during COVID-19 outbreak</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">138</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Patient Underwent Bariatric Surgery</condition>
  <arm_group>
    <arm_group_label>Bariatric Patient</arm_group_label>
    <description>Inclusion criteria were as follows: obese adults (&gt; 18 years of age, BMI&gt; 40 or &gt; 35 with comorbidities) older than 18 years; patients undergoing bariatric surgery within 6 months; patients who required clinical and instrumental control; presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine to remote outpatient visit in bariatric patient</intervention_name>
    <description>Patients that referred for the first time to our bariatric center were investigated for anthropometric, psychological and instrumental data in order to evaluate the eligibility for a future bariatric procedure. In established patients, eligibility for tele-consultation was evaluated by three experienced physicians, consulting the stored patients' data. All included patients provided oral informed consent. Patients approached the virtual visit with their personal smart devices, desktop or laptop computer. Medical counselling was performed using a desktop or laptop computer from the Hospital or home in a smart working modality. The video call was carried out using Skype platform by Microsoft®; any document drawn up by the physician was saved as pdf using the Cute Professional™ PDF software, that allows to add passwords and set security options to protect the patients' data.</description>
    <arm_group_label>Bariatric Patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 138/175 patients (78.8%) were eligible for telemedicine (66 established&#xD;
        patients, 25 undergoing surgery within 30 days and 47 for the first time referred to our&#xD;
        center).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  obese adults (&gt; 18 years of age, BMI&gt; 40 or &gt; 35 with comorbidities) older than 18&#xD;
             years&#xD;
&#xD;
          -  patients undergoing bariatric surgery within 6 months&#xD;
&#xD;
          -  patients who required clinical and instrumental control&#xD;
&#xD;
          -  presence of a caregiver in case of subject with cognitive impairment; patients with a&#xD;
             history of bariatric surgery who requested a first outpatients access or established&#xD;
             patients who requested an outpatients' visit for an emerging problem.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  virtual visit decline&#xD;
&#xD;
          -  the internet or smart devices unavailability&#xD;
&#xD;
          -  need for physical examination or radiological investigations established during a&#xD;
             preliminary contact by phone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Campania &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Claudio Gambardella</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04407663
org study id: Telemedicine
nct id: NCT04407663
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Bariatric patients represent a peculiar and frail subset of subjects, constantly increasing.
      During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and
      non-oncological activity, the access to healthcare services was severely limited, according
      to the International Federation for the Surgery of Obesity and Metabolic Disorders.
The constant and strict follow-up is mandatory in this special subset of patients. Therefore,
      starting from the telemedicine experience in different medical fields, in our bariatric
      surgery division we designed and started a dedicated project to follow-up obese patients
      using remote counselling.
observational model: Cohort
time perspective: Retrospective
measure: Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients
time frame: 2 months
description: Telemedicine to follow-up and identify sing or symptom of alarm in patient undergoing bariatric surgery or in established bariatric patients during COVID-19 outbreak
arm group label: Bariatric Patient
description: Inclusion criteria were as follows: obese adults (> 18 years of age, BMI> 40 or > 35 with comorbidities) older than 18 years; patients undergoing bariatric surgery within 6 months; patients who required clinical and instrumental control; presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.
intervention type: Other
intervention name: Telemedicine to remote outpatient visit in bariatric patient
description: Patients that referred for the first time to our bariatric center were investigated for anthropometric, psychological and instrumental data in order to evaluate the eligibility for a future bariatric procedure. In established patients, eligibility for tele-consultation was evaluated by three experienced physicians, consulting the stored patients' data. All included patients provided oral informed consent. Patients approached the virtual visit with their personal smart devices, desktop or laptop computer. Medical counselling was performed using a desktop or laptop computer from the Hospital or home in a smart working modality. The video call was carried out using Skype platform by Microsoft®; any document drawn up by the physician was saved as pdf using the Cute Professional™ PDF software, that allows to add passwords and set security options to protect the patients' data.
arm group label: Bariatric Patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Claudio Gambardella
investigator title: Researcher
mesh term: Obesity
sharing ipd: Undecided