<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/NCT04400448</url>
  </required_header>
  <id_info>
    <org_study_id>TELECOVID</org_study_id>
    <nct_id>NCT04400448</nct_id>
  </id_info>
  <brief_title>Acceptance of Telemedicine During the COVID-19 Pandemic</brief_title>
  <official_title>Acceptance of Telemedicine in Outpatient Clinic Consultations During COVID-19 Pandemic. An International, Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</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>
      Currently, due to the effects of COVID-19 pandemic, there is an imperative need to change the&#xD;
      healthcare model. In this regard, telemedicine has proved very useful in health crises, in&#xD;
      which there is a possibility of infection between people, offering remote access to medical&#xD;
      care. Telemedicine has been used in many chronic diseases such as asthma and chronic&#xD;
      obstructive pulmonary disease, diabetes mellitus, and appears to be well accepted by&#xD;
      patients. However, few studies have been conducted in surgical services and in other&#xD;
      diseases. Therefore, the aim of this study is to assess the level of acceptance of the&#xD;
      patients, in this pandemic situation, to a telemedicine follow-up in different departments.&#xD;
&#xD;
      This is an observational, cross-sectional, multicenter and international study with&#xD;
      prospective and retrospective data collection. To evaluate patients' acceptance, we used the&#xD;
      validated questionnaire Telehealth usability questionnaire (TUQ). In addition, all patients&#xD;
      will provide an overall satisfaction score for telemedicine on a scale from 1 to 5 (1=lowest;&#xD;
      5=highest satisfaction).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Acceptance of telemedicine</measure>
    <time_frame>1 month</time_frame>
    <description>Acceptance of telemedicine in consultations during the COVID-19 pandemic. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ) as a model. The resulting questionnaire has 10 questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>1 month</time_frame>
    <description>Global satisfaction score on a scale from1 to 5 (1=lowest; 5=highest satisfaction)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who met the described inclusion criteria will be included in the registry.&#xD;
        Participants will be asked to answer an anonymous and voluntary questionnaire by telephone,&#xD;
        that will be completed online by the researcher and collaborators through a Google form,&#xD;
        aimed to assess the acceptance of the use of telemedicine in consultations during the&#xD;
        pandemic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients contacted by telemedicine (phone and/or video call) during the COVID-19&#xD;
             pandemic in outpatient clinics&#xD;
&#xD;
          -  Follow-up of patients with any chronic disease and postoperative patients,&#xD;
             preoperative and urgent consultation&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cognitive or sensory difficulties or with insufficient comprehension of&#xD;
             the language in which the survey is conducted&#xD;
&#xD;
          -  Patients who decline to take part in the telephone survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</investigator_affiliation>
    <investigator_full_name>Luis Sánchez Guillen</investigator_full_name>
    <investigator_title>Colorectal Surgeon Hospital General Universitario Elche</investigator_title>
  </responsible_party>
  <keyword>telemedicine</keyword>
  <keyword>patient acceptance</keyword>
  <keyword>covid-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04400448
org study id: TELECOVID
nct id: NCT04400448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Currently, due to the effects of COVID-19 pandemic, there is an imperative need to change the
      healthcare model. In this regard, telemedicine has proved very useful in health crises, in
      which there is a possibility of infection between people, offering remote access to medical
      care. Telemedicine has been used in many chronic diseases such as asthma and chronic
      obstructive pulmonary disease, diabetes mellitus, and appears to be well accepted by
      patients. However, few studies have been conducted in surgical services and in other
      diseases. Therefore, the aim of this study is to assess the level of acceptance of the
      patients, in this pandemic situation, to a telemedicine follow-up in different departments.

      This is an observational, cross-sectional, multicenter and international study with
      prospective and retrospective data collection. To evaluate patients' acceptance, we used the
      validated questionnaire Telehealth usability questionnaire (TUQ). In addition, all patients
      will provide an overall satisfaction score for telemedicine on a scale from 1 to 5 (1=lowest;
      5=highest satisfaction).
observational model: Ecologic or Community
time perspective: Prospective
measure: Acceptance of telemedicine
time frame: 1 month
description: Acceptance of telemedicine in consultations during the COVID-19 pandemic. To evaluate patients' acceptance, we used the validated questionnaire Telehealth usability questionnaire (TUQ) as a model. The resulting questionnaire has 10 questions.
measure: Patient satisfaction
time frame: 1 month
description: Global satisfaction score on a scale from1 to 5 (1=lowest; 5=highest satisfaction)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
investigator full name: Luis Sánchez Guillen
investigator title: Colorectal Surgeon Hospital General Universitario Elche
mesh term: COVID-19
sharing ipd: Undecided