<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/NCT03252275</url>
  </required_header>
  <id_info>
    <org_study_id>MUST 21/06-16</org_study_id>
    <nct_id>NCT03252275</nct_id>
  </id_info>
  <brief_title>Peer Learning and HBB in Managing Maternal Newborn and Child Health Emergencies in Rural Uganda</brief_title>
  <acronym>SimForLife</acronym>
  <official_title>Use of Simulation Based Education With Peer Learning to Enhance HBB Training for Managing Maternal Newborn and Child Health Emergencies in Rural Uganda: A Cluster-randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mbarara University of Science and Technology</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>
      The aim of this study is to test an intervention that has potential to improve acute care&#xD;
      skills and confidence related to safe delivery and newborn care for mid-level health&#xD;
      providers in Uganda by the development of a 'mobile' simulation package including scale-up&#xD;
      materials based upon research evidence. In this randomized study investigators will compare&#xD;
      the impact of a peer learning package on skills, knowledge and team work regarding newborn&#xD;
      care among health workers in rural south western Uganda.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to test an intervention that has potential to improve acute care&#xD;
      skills and confidence related to safe delivery and newborn care for mid-level health&#xD;
      providers in Uganda by the development of a 'mobile' simulation package including scale-up&#xD;
      materials based upon research evidence. In this randomized study investigators will compare&#xD;
      the impact of a peer learning package on skills, knowledge and team work regarding newborn&#xD;
      care among health workers in rural south western Uganda.&#xD;
&#xD;
      The cluster randomized study will have two arms; intervention arm receives peer learning&#xD;
      program. In this program, two health workers at the same health facility teach each other&#xD;
      using case scenarios. The case scenarios will be based on common neonatal conditions such as&#xD;
      neonatal sepsis, hypothermia and prematurity.&#xD;
&#xD;
      The two study arms will both receive training on HBB and Essential care for every baby (ECEB)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 30, 2017</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">January 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>
    <intervention_model_description>We will conduct a parallel comparison of intervention and control arms to measure study endpoints</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skills on key maternal, newborn and child health emergency procedures</measure>
    <time_frame>Change in skills scores at 6 and 12 months from Baseline</time_frame>
    <description>Ability to perform key maternal, new born and child health emergency procedures measured using Multiple choice questions (MCQs). A composite score with a maximum of 100% will be computed from these MCQs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical teamwork scores</measure>
    <time_frame>Change in CTS scores at 6 and 12 months from Baseline</time_frame>
    <description>Ability to work as a team through communication, sharing roles and completing tasks together measured using the Clinical Teamwork scale (CTS). A composite score will be computed by adding up all the items on the CTS scale. CTS has 15 items, each item with a maximum score of 10</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">77</enrollment>
  <condition>Maternal, Newborn and Child Health Emergencies</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard HBB and ECEB training with peer learning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard HBB and ECEB training only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peer learning</intervention_name>
    <description>Peer learning plus HBB and ECEB</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Health workers involved in performing deliveries of mothers at health center IVs and&#xD;
             IIIs (i.e, county and subcounty level)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health facilities based in municipalities, urban dwellings&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santorini Data, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mbarara University of Science and Technology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Santorini Data, MD</last_name>
    <phone>+256752214458</phone>
    <email>sdata@must.ac.ug</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Francis Bajunirwe, PhD</last_name>
    <phone>+256772576396</phone>
    <email>fbaj@must.ac.ug</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Authorization to share data will be sought</ipd_description>
  </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/NCT03252275
org study id: MUST 21/06-16
nct id: NCT03252275
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to test an intervention that has potential to improve acute care
      skills and confidence related to safe delivery and newborn care for mid-level health
      providers in Uganda by the development of a 'mobile' simulation package including scale-up
      materials based upon research evidence. In this randomized study investigators will compare
      the impact of a peer learning package on skills, knowledge and team work regarding newborn
      care among health workers in rural south western Uganda.
The aim of this study is to test an intervention that has potential to improve acute care
      skills and confidence related to safe delivery and newborn care for mid-level health
      providers in Uganda by the development of a 'mobile' simulation package including scale-up
      materials based upon research evidence. In this randomized study investigators will compare
      the impact of a peer learning package on skills, knowledge and team work regarding newborn
      care among health workers in rural south western Uganda.

      The cluster randomized study will have two arms; intervention arm receives peer learning
      program. In this program, two health workers at the same health facility teach each other
      using case scenarios. The case scenarios will be based on common neonatal conditions such as
      neonatal sepsis, hypothermia and prematurity.

      The two study arms will both receive training on HBB and Essential care for every baby (ECEB)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will conduct a parallel comparison of intervention and control arms to measure study endpoints
primary purpose: Other
masking: None (Open Label)
measure: Skills on key maternal, newborn and child health emergency procedures
time frame: Change in skills scores at 6 and 12 months from Baseline
description: Ability to perform key maternal, new born and child health emergency procedures measured using Multiple choice questions (MCQs). A composite score with a maximum of 100% will be computed from these MCQs
measure: Clinical teamwork scores
time frame: Change in CTS scores at 6 and 12 months from Baseline
description: Ability to work as a team through communication, sharing roles and completing tasks together measured using the Clinical Teamwork scale (CTS). A composite score will be computed by adding up all the items on the CTS scale. CTS has 15 items, each item with a maximum score of 10
arm group label: Intervention
arm group type: Experimental
description: Standard HBB and ECEB training with peer learning
arm group label: Control
arm group type: No Intervention
description: Standard HBB and ECEB training only
intervention type: Other
intervention name: Peer learning
description: Peer learning plus HBB and ECEB
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Santorini Data, MD
role: Principal Investigator
affiliation: Mbarara University of Science and Technology
last name: Santorini Data, MD
phone: +256752214458
email: sdata@must.ac.ug
last name: Francis Bajunirwe, PhD
phone: +256772576396
email: fbaj@must.ac.ug
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: Undecided
ipd description: Authorization to share data will be sought