<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/NCT02193854</url>
  </required_header>
  <id_info>
    <org_study_id>TaipeiMU</org_study_id>
    <nct_id>NCT02193854</nct_id>
  </id_info>
  <brief_title>Teledermatology Solution Through Mobile Phone in Rural Mongolia</brief_title>
  <official_title>Teledermatology Solution Through Mobile Phone in Rural Mongolia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Science University of Mongolia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective This study is aimed to estimate the distance, time and the cost of travel saved by&#xD;
      patients who are seeking tele-dermatology (TD) service though smart mobile phones in the&#xD;
      resource poor settings at the rural clinics of Mongolia.&#xD;
&#xD;
      Methods A cluster-randomised trial was conducted for six months at the 20 rural health&#xD;
      clinics selected from three districts in Mongolia. With a computer-generated sequence, health&#xD;
      clinics were randomly allocated either to the intervention group, in which all general&#xD;
      practitioners (GPs) received TD consultation through Sana system, or the control group, in&#xD;
      which GPs referred patients to the dermatologist at district hospital whenever needed. The&#xD;
      primary outcome was to estimate the distance traveled, times spend and the cost of travel&#xD;
      required in receiving dermal care for patients in rural Mongolia. Analysis was done to&#xD;
      estimate the difference between the aforementioned parameters among intervention and control&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators used Sana system, that is a mobile phone-based, open source software&#xD;
      platform for telemedicine services. The Android-based system supports multimedia,&#xD;
      location-based data, and text. In the village health clinic, a healthcare worker will&#xD;
      interact with a patient and collects data through a step-by-step clinical questionnaire on a&#xD;
      smart mobile phone. As patients' data is uploaded to an open source electronic medical record&#xD;
      system (OpenMRS) with a diagnosis-specific information and images. The consultant can access&#xD;
      the clinical information about the patient and make appropriate diagnoses and treatment&#xD;
      recommendations from the secondary hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between the number of referrals in the control and intervention groups</measure>
    <time_frame>up to 5 months</time_frame>
    <description>Outcome measures are the number of referrals done in the control and in the intervention groups. We compared the difference in the number of referrals with Sana system and without.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction by physicians and patients by questionnaire</measure>
    <time_frame>up to 5 months</time_frame>
    <description>Both physicians and patients who were in the intervention group were satisfied by the Sana system.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">441</enrollment>
  <condition>Social Distance</condition>
  <arm_group>
    <arm_group_label>Mobile phone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>General practitioners (GPs) received TD consultation through Sana system.&#xD;
Mobile phones with Sana system installed were provided to 10 rural GPs from three different districts of Mongolia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile Phone</intervention_name>
    <description>Investigators used Sana system, that is a mobile phone-based, open source software platform for telemedicine services. The Android-based system supports multimedia, location-based data, and text. In the village health clinic, a healthcare worker will interact with a patient and collects data through a step-by-step clinical questionnaire on a smart mobile phone. As patients' data is uploaded to an open source electronic medical record system (OpenMRS) with a diagnosis-specific information and images. The consultant can access the clinical information about the patient and make appropriate diagnoses and treatment recommendations from the secondary hospital.</description>
    <arm_group_label>Mobile phone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-98 years visiting with dermal problem.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not need dermal care.&#xD;
&#xD;
          -  Patients who are already under treatment for dermal problem.&#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>Yu-Chuan Li, MD., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shabbir Syed Abdul</name>
      <address>
        <city>Taipei</city>
        <zip>11031</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://ichit.tmu.edu.tw</url>
    <description>International Center for Health Information Technologies</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Mobile phone</keyword>
  <keyword>Rural physicians</keyword>
  <keyword>Mongolia</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/NCT02193854
org study id: TaipeiMU
nct id: NCT02193854
lead sponsor: 
collaborator: 
has dmc: No
Objective This study is aimed to estimate the distance, time and the cost of travel saved by
      patients who are seeking tele-dermatology (TD) service though smart mobile phones in the
      resource poor settings at the rural clinics of Mongolia.

      Methods A cluster-randomised trial was conducted for six months at the 20 rural health
      clinics selected from three districts in Mongolia. With a computer-generated sequence, health
      clinics were randomly allocated either to the intervention group, in which all general
      practitioners (GPs) received TD consultation through Sana system, or the control group, in
      which GPs referred patients to the dermatologist at district hospital whenever needed. The
      primary outcome was to estimate the distance traveled, times spend and the cost of travel
      required in receiving dermal care for patients in rural Mongolia. Analysis was done to
      estimate the difference between the aforementioned parameters among intervention and control
      groups.
The investigators used Sana system, that is a mobile phone-based, open source software
      platform for telemedicine services. The Android-based system supports multimedia,
      location-based data, and text. In the village health clinic, a healthcare worker will
      interact with a patient and collects data through a step-by-step clinical questionnaire on a
      smart mobile phone. As patients' data is uploaded to an open source electronic medical record
      system (OpenMRS) with a diagnosis-specific information and images. The consultant can access
      the clinical information about the patient and make appropriate diagnoses and treatment
      recommendations from the secondary hospital.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Comparison between the number of referrals in the control and intervention groups
time frame: up to 5 months
description: Outcome measures are the number of referrals done in the control and in the intervention groups. We compared the difference in the number of referrals with Sana system and without.
measure: Satisfaction by physicians and patients by questionnaire
time frame: up to 5 months
description: Both physicians and patients who were in the intervention group were satisfied by the Sana system.
arm group label: Mobile phone
arm group type: Experimental
description: General practitioners (GPs) received TD consultation through Sana system.
Mobile phones with Sana system installed were provided to 10 rural GPs from three different districts of Mongolia.
intervention type: Device
intervention name: Mobile Phone
description: Investigators used Sana system, that is a mobile phone-based, open source software platform for telemedicine services. The Android-based system supports multimedia, location-based data, and text. In the village health clinic, a healthcare worker will interact with a patient and collects data through a step-by-step clinical questionnaire on a smart mobile phone. As patients' data is uploaded to an open source electronic medical record system (OpenMRS) with a diagnosis-specific information and images. The consultant can access the clinical information about the patient and make appropriate diagnoses and treatment recommendations from the secondary hospital.
arm group label: Mobile phone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yu-Chuan Li, MD., PhD.
role: Principal Investigator
affiliation: Taipei Medical University
facility: 
country: Taiwan
url: http://ichit.tmu.edu.tw
description: International Center for Health Information Technologies
responsible party type: Sponsor