<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/NCT02971449</url>
  </required_header>
  <id_info>
    <org_study_id>BMAChartiableGrant2016</org_study_id>
    <nct_id>NCT02971449</nct_id>
  </id_info>
  <brief_title>Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers.</brief_title>
  <official_title>Using mHealth Tools to Deliver Integrated Community Case Management (ICCM) to Village Health Team (VHT) Volunteers in Uganda.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Omni Med</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Omni Med</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the traditional, didactic method of training Ugandan community health&#xD;
      workers with training using tablets in pneumonia management, a common, life-threatening&#xD;
      illness in children in rural areas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current ICCM (Integrated Community Case Management) training in Uganda involves CHWs&#xD;
      physically attending a five-day workshop, which is both expensive, time consuming and&#xD;
      requires trainer's to be physically present to deliver training materials. The investigators&#xD;
      hypothesize that use of a low-cost android tablet, with pre-loaded instructional educational&#xD;
      videos will improve the baseline knowledge and retention of knowledge of CHWs as well as&#xD;
      lower the direct and indirect costs of ICCM training.&#xD;
&#xD;
      The investigators will conduct a randomized controlled trial in two sub-counties in Mukono&#xD;
      district among CHWs to test these two hypotheses. In this study, the investigators will focus&#xD;
      solely on the pneumonia component of ICCM training, instead of testing the full week-long&#xD;
      training course including malaria, pneumonia, and diarrhea. (The investigators plan a later&#xD;
      trial encompassing the entire week-long training vs the same uploaded into the tablets.) The&#xD;
      investigators will enroll 200 CHWs in the study, with 100 in a control group who will receive&#xD;
      a one day in-person training session focusing on pneumonia, similar to traditional ICCM&#xD;
      training and 100 in an intervention group who will receive tablets with instructional&#xD;
      training videos. The investigators will administer a written test prior to the training in&#xD;
      both groups, then administer the same written test one week later. Additionally, the&#xD;
      investigators will test both groups with clinical case scenarios that give these community&#xD;
      health workers realistic clinical cases and challenge them to diagnose pneumonia, state&#xD;
      whether patient should be treated in the home or brought to hospital, and how to initiate and&#xD;
      complete management if patients are to be referred or kept home, respectively. The sample&#xD;
      sizes will enable the investigators carry out independent t-tests and a paired two-sample&#xD;
      t-test to determine the significance of pre- and post-test scores for the control and&#xD;
      intervention groups. If training delivered via low-cost android tablets proves to be both&#xD;
      effective and acceptable, this option may represent a viable, scalable and cost-effective&#xD;
      alternative to the traditional training model used throughout Uganda.&#xD;
&#xD;
      Furthermore, the MoH could institute an incentive policy that allows tablets to be&#xD;
      distributed and retained by health workers provided that they maintain a quarterly flow of&#xD;
      information back to the MoH regarding home visits, patients referred, or other community&#xD;
      actions. Should the learning and cost efficacy prove viable, the investigators can envision&#xD;
      tablets throughout Mukono District, allowing the more direct transfer of information, disease&#xD;
      patterns, index cases of pathogens like Ebola, tracking of data for the Ministry, regular&#xD;
      dissemination of training materials, and opportunities for CHWs gain employment in the health&#xD;
      sector.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Is VHT knowledge retention comparable or superior when comparing the use of tablets with standard Ugandan ICCM training methods in the recognition and management of pneumonia in children by Ugandan VHTs?</measure>
    <time_frame>2 months</time_frame>
    <description>There will be 2 arms of the study to see if pre-loaded instructional videos on a low cost android tablet are either superior to or comparable to standard training methods in the training of VHTs in Mukono, Uganda in terms of recognition, prevention and management of pneumonia in children under 5 years old in line with ICCM guidelines. One group will receive normal ICCM training by attending the standard, didactic ICCM training workshop held in the community. The second, Interventional arm will utilize Ministry approved training videos pre-loaded into low cost android tablets. The overall aim of the study is to assess whether or not the tablets can replace the current time-consuming and expensive methods used throughout Uganda.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost efficacy of the Tablet Approach to ICCM Training</measure>
    <time_frame>2 months</time_frame>
    <description>We will perform detailed cost analysis for both arms of this trial. Generally, it is expensive to bring a group of VHTs together for trainings, with costs including transport, food, instructors, petrol, and materials. By contrast, getting tablets out to VHTs with simple user instructions allows learning to happen at home, and repeatedly by watching the videos over and over again.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Community Health Services</condition>
  <condition>Telemedicine</condition>
  <arm_group>
    <arm_group_label>Tablets only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 VHTs will receive Amazon Fire Tablets with pre-loaded instructional videos; this is the intervention arm since this involves introduction of a new technology to this realm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICCM traditional training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 VHTs will receive traditional 1 day 'in-person' training as an active comparator intervention, but participants in this arm will not receive any tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Amazon Fire Tablet</intervention_name>
    <description>A generic amazon fire tablet with pre-loaded instructional videos</description>
    <arm_group_label>Tablets only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ICCM Traditional Trainins</intervention_name>
    <description>Standard, Didactic VHT Training intervention as an active comparator</description>
    <arm_group_label>ICCM traditional training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be a registered VHT working in the study areas in Uganda;&#xD;
&#xD;
          -  Must express a commitment to aim to complete the duration of the study;&#xD;
&#xD;
          -  Willingness to be randomised to the control or intervention group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Unregistered VHTs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward J O'Neil Jr, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omni Med</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James O'Donovan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Omni Med</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Edward J O'Neil, MD</last_name>
    <email>ejoneil@omnimed.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>James J O'Donovan, MBBS</last_name>
    <email>jamesodonovan@post.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Omni Med</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02468</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edward J O'Neil Jr., MD</last_name>
      <phone>617-332-9614</phone>
      <email>ejoneil@omnimed.org</email>
    </contact>
    <contact_backup>
      <last_name>Keneth Kabali, MD</last_name>
      <phone>+256-772-585-830</phone>
      <email>kenkysy@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Edward J O'Neil Jr, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benjamin J Lough, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>James O'Donovan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Omni Med</name>
      <address>
        <city>Kisoga</city>
        <state>Mukono</state>
        <country>Uganda</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenneth Kabali, MD</last_name>
      <phone>+256-772-585-830</phone>
      <email>kenkysy@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Edward M Mwebe</last_name>
      <phone>+256782316612</phone>
      <email>edward.mutimba@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>James O'Donovan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edward J O'Neil Jr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kenneth Kabali, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Margarita Chukhina, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alan Penman, MD, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jacqueline Kading, BS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edward M Mwebe</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Uganda</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Village Healthcare Team</keyword>
  <keyword>mHealth</keyword>
  <keyword>Telemedicine</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02971449
org study id: BMAChartiableGrant2016
nct id: NCT02971449
lead sponsor: 
has dmc: Yes
This study compares the traditional, didactic method of training Ugandan community health
      workers with training using tablets in pneumonia management, a common, life-threatening
      illness in children in rural areas.
Current ICCM (Integrated Community Case Management) training in Uganda involves CHWs
      physically attending a five-day workshop, which is both expensive, time consuming and
      requires trainer's to be physically present to deliver training materials. The investigators
      hypothesize that use of a low-cost android tablet, with pre-loaded instructional educational
      videos will improve the baseline knowledge and retention of knowledge of CHWs as well as
      lower the direct and indirect costs of ICCM training.

      The investigators will conduct a randomized controlled trial in two sub-counties in Mukono
      district among CHWs to test these two hypotheses. In this study, the investigators will focus
      solely on the pneumonia component of ICCM training, instead of testing the full week-long
      training course including malaria, pneumonia, and diarrhea. (The investigators plan a later
      trial encompassing the entire week-long training vs the same uploaded into the tablets.) The
      investigators will enroll 200 CHWs in the study, with 100 in a control group who will receive
      a one day in-person training session focusing on pneumonia, similar to traditional ICCM
      training and 100 in an intervention group who will receive tablets with instructional
      training videos. The investigators will administer a written test prior to the training in
      both groups, then administer the same written test one week later. Additionally, the
      investigators will test both groups with clinical case scenarios that give these community
      health workers realistic clinical cases and challenge them to diagnose pneumonia, state
      whether patient should be treated in the home or brought to hospital, and how to initiate and
      complete management if patients are to be referred or kept home, respectively. The sample
      sizes will enable the investigators carry out independent t-tests and a paired two-sample
      t-test to determine the significance of pre- and post-test scores for the control and
      intervention groups. If training delivered via low-cost android tablets proves to be both
      effective and acceptable, this option may represent a viable, scalable and cost-effective
      alternative to the traditional training model used throughout Uganda.

      Furthermore, the MoH could institute an incentive policy that allows tablets to be
      distributed and retained by health workers provided that they maintain a quarterly flow of
      information back to the MoH regarding home visits, patients referred, or other community
      actions. Should the learning and cost efficacy prove viable, the investigators can envision
      tablets throughout Mukono District, allowing the more direct transfer of information, disease
      patterns, index cases of pathogens like Ebola, tracking of data for the Ministry, regular
      dissemination of training materials, and opportunities for CHWs gain employment in the health
      sector.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Is VHT knowledge retention comparable or superior when comparing the use of tablets with standard Ugandan ICCM training methods in the recognition and management of pneumonia in children by Ugandan VHTs?
time frame: 2 months
description: There will be 2 arms of the study to see if pre-loaded instructional videos on a low cost android tablet are either superior to or comparable to standard training methods in the training of VHTs in Mukono, Uganda in terms of recognition, prevention and management of pneumonia in children under 5 years old in line with ICCM guidelines. One group will receive normal ICCM training by attending the standard, didactic ICCM training workshop held in the community. The second, Interventional arm will utilize Ministry approved training videos pre-loaded into low cost android tablets. The overall aim of the study is to assess whether or not the tablets can replace the current time-consuming and expensive methods used throughout Uganda.
measure: Cost efficacy of the Tablet Approach to ICCM Training
time frame: 2 months
description: We will perform detailed cost analysis for both arms of this trial. Generally, it is expensive to bring a group of VHTs together for trainings, with costs including transport, food, instructors, petrol, and materials. By contrast, getting tablets out to VHTs with simple user instructions allows learning to happen at home, and repeatedly by watching the videos over and over again.
arm group label: Tablets only
arm group type: Experimental
description: 100 VHTs will receive Amazon Fire Tablets with pre-loaded instructional videos; this is the intervention arm since this involves introduction of a new technology to this realm
arm group label: ICCM traditional training
arm group type: Active Comparator
description: 100 VHTs will receive traditional 1 day 'in-person' training as an active comparator intervention, but participants in this arm will not receive any tablets
intervention type: Device
intervention name: Amazon Fire Tablet
description: A generic amazon fire tablet with pre-loaded instructional videos
arm group label: Tablets only
intervention type: Other
intervention name: ICCM Traditional Trainins
description: Standard, Didactic VHT Training intervention as an active comparator
arm group label: ICCM traditional training
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Edward J O'Neil Jr, MD
role: Principal Investigator
affiliation: Omni Med
last name: James O'Donovan, MD
role: Principal Investigator
affiliation: Omni Med
last name: Edward J O'Neil, MD
email: ejoneil@omnimed.org
last name: James J O'Donovan, MBBS
email: jamesodonovan@post.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Uganda
country: United States
responsible party type: Sponsor
sharing ipd: No