<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/NCT04423289</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)182-2020</org_study_id>
    <nct_id>NCT04423289</nct_id>
  </id_info>
  <brief_title>Telematic Monitoring Through a Mobile Application of Patients With COVID-19</brief_title>
  <official_title>COVID Follow-App: Telematic Monitoring Through a Mobile Application of Patients With COVID-19: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</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>
      Open-label randomized clinical trial, one center, to compare the need for face-to-face&#xD;
      re-consultation after discharge for COVID-19 between a telematic monitoring through a mobile&#xD;
      app and the regular primary care setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, open-label clinical trial, at one center, a 1100-bed academic hospital, Vall&#xD;
      d'Hebron Hospital Universitari, in Barcelona, Spain. Patients who met the enrolment criteria&#xD;
      were randomly assigned, in a 1:1 ratio, to be followed by the Farmalarm app or the primary&#xD;
      care setting.&#xD;
&#xD;
      Farmalarm is an app for smartphones designed to increase stroke awareness and treatment&#xD;
      compliance through visual and audible alerts. The application's software offers versatility&#xD;
      to modify the parameters to be monitored and the information to be sent, which were adapted&#xD;
      to our purpose.&#xD;
&#xD;
      Intervention was started after the patient was discharged and underwent randomization. At&#xD;
      this moment, patients assigned to the study group were given a personal access code ensuring&#xD;
      data privacy, and they were lent an intelligent pulse oximeter (SMART PULSE OXIMETER OL-750,&#xD;
      LifeVit, Guangdong Biolight Meditech CO., LTD, China). In a 15 minutes interview they were&#xD;
      trained in the use of the app, the use of the pulse oximeter and the measurement of some&#xD;
      vital signs.&#xD;
&#xD;
      On that same day, the healthcare professional uploaded and scheduled on the web-based&#xD;
      platform a personalized program for the following 2 weeks.&#xD;
&#xD;
      To maintain close control of respiratory evolution, patients registered at least 2 times a&#xD;
      day their heart rate, respiratory rate, temperature and peripheral capillary oxygen&#xD;
      saturation. The intelligent pulse oximeter allowed data to be downloaded directly to the WP&#xD;
      every time the patient used it. They also had to answer a symptom survey every day for the&#xD;
      same period. The WP allows scheduling alarms and so, in case one of the vital signs or survey&#xD;
      responses were altered, the healthcare in charge automatically received a notification, being&#xD;
      able to contact immediately the patient. A private chat between the patient and the&#xD;
      healthcare responsible for WP was attended every day from 8 AM to 5 PM to answer any doubt.&#xD;
&#xD;
      Patients assigned to control group received regular follow-up at the Primary Care, which used&#xD;
      phone calls to monitor patients' symptoms. Depending on the availability of human resources&#xD;
      of each Primary Care Centre and the care pressure of the moment, these phone calls were made&#xD;
      every 2 days, weekly, or just once during the whole follow-up period.&#xD;
&#xD;
      All patients were followed for two weeks. At the end of follow-up, all patients answered an&#xD;
      end-of-follow-up questionnaire and a Patient-Reported Outcomes Measurement Information System&#xD;
      (PROMIS) questionnaire about global health. The end-of-follow-up interview of experimental&#xD;
      group patients was carried by videoconference through the app. Control group patients were&#xD;
      telephonically contacted. All patients also answered a Hospital Anxiety and Depression Scale&#xD;
      (HADS) the same day of discharge and again at the end of follow-up. 12&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2020</start_date>
  <completion_date type="Actual">May 18, 2020</completion_date>
  <primary_completion_date type="Actual">May 4, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Re-consultation</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of patients needing face-to-face re-consultations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Telephone calls</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of patients making telephone calls to emergency services</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Face-to-face Reconsultation to Emergency Room</condition>
  <arm_group>
    <arm_group_label>Farmalarm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Farmalarm app for the follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Regular primary care follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Farmalarm</intervention_name>
    <description>Monitoring after COVID-19 discharge from hospital via Farmalarm app</description>
    <arm_group_label>Farmalarm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an age of 18 years or older,&#xD;
&#xD;
          -  availability of a mobile device such a phone or a tablet with connectivity to the&#xD;
             internet, and&#xD;
&#xD;
          -  discharged from hospital after admission for COVID-19 diagnosed by RT-PCR.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  health personnel (medical or nursing staff) or&#xD;
&#xD;
          -  discharged to care centers or medicalized hotels enabled to complete the period of&#xD;
             isolation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oscar Len, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vall d'Hebron Hospital Universitari</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vall d'Hebron Hospital Universitari</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT04423289
org study id: PR(AG)182-2020
nct id: NCT04423289
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Open-label randomized clinical trial, one center, to compare the need for face-to-face
      re-consultation after discharge for COVID-19 between a telematic monitoring through a mobile
      app and the regular primary care setting.
A randomized, open-label clinical trial, at one center, a 1100-bed academic hospital, Vall
      d'Hebron Hospital Universitari, in Barcelona, Spain. Patients who met the enrolment criteria
      were randomly assigned, in a 1:1 ratio, to be followed by the Farmalarm app or the primary
      care setting.

      Farmalarm is an app for smartphones designed to increase stroke awareness and treatment
      compliance through visual and audible alerts. The application's software offers versatility
      to modify the parameters to be monitored and the information to be sent, which were adapted
      to our purpose.

      Intervention was started after the patient was discharged and underwent randomization. At
      this moment, patients assigned to the study group were given a personal access code ensuring
      data privacy, and they were lent an intelligent pulse oximeter (SMART PULSE OXIMETER OL-750,
      LifeVit, Guangdong Biolight Meditech CO., LTD, China). In a 15 minutes interview they were
      trained in the use of the app, the use of the pulse oximeter and the measurement of some
      vital signs.

      On that same day, the healthcare professional uploaded and scheduled on the web-based
      platform a personalized program for the following 2 weeks.

      To maintain close control of respiratory evolution, patients registered at least 2 times a
      day their heart rate, respiratory rate, temperature and peripheral capillary oxygen
      saturation. The intelligent pulse oximeter allowed data to be downloaded directly to the WP
      every time the patient used it. They also had to answer a symptom survey every day for the
      same period. The WP allows scheduling alarms and so, in case one of the vital signs or survey
      responses were altered, the healthcare in charge automatically received a notification, being
      able to contact immediately the patient. A private chat between the patient and the
      healthcare responsible for WP was attended every day from 8 AM to 5 PM to answer any doubt.

      Patients assigned to control group received regular follow-up at the Primary Care, which used
      phone calls to monitor patients' symptoms. Depending on the availability of human resources
      of each Primary Care Centre and the care pressure of the moment, these phone calls were made
      every 2 days, weekly, or just once during the whole follow-up period.

      All patients were followed for two weeks. At the end of follow-up, all patients answered an
      end-of-follow-up questionnaire and a Patient-Reported Outcomes Measurement Information System
      (PROMIS) questionnaire about global health. The end-of-follow-up interview of experimental
      group patients was carried by videoconference through the app. Control group patients were
      telephonically contacted. All patients also answered a Hospital Anxiety and Depression Scale
      (HADS) the same day of discharge and again at the end of follow-up. 12
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Re-consultation
time frame: 2 weeks
description: Number of patients needing face-to-face re-consultations
measure: Telephone calls
time frame: 2 weeks
description: Number of patients making telephone calls to emergency services
arm group label: Farmalarm
arm group type: Experimental
description: Farmalarm app for the follow-up
arm group label: Control
arm group type: No Intervention
description: Regular primary care follow-up
intervention type: Other
intervention name: Farmalarm
description: Monitoring after COVID-19 discharge from hospital via Farmalarm app
arm group label: Farmalarm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oscar Len, MD, PhD
role: Principal Investigator
affiliation: Vall d'Hebron Hospital Universitari
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Emergencies