<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/NCT03269240</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00007196</org_study_id>
    <nct_id>NCT03269240</nct_id>
  </id_info>
  <brief_title>Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Study in Nigeria</brief_title>
  <acronym>LDHF-Nigeria</acronym>
  <official_title>A Comparative Study of Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Versus Traditional Group-based Training Approaches Among Maternal and Newborn Healthcare Providers in Ebonyi and Kogi States, Nigeria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jhpiego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jhpiego</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 compare the effectiveness and cost of a simulation-based low dose&#xD;
      high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training&#xD;
      approaches in improving knowledge and skill in maternal and newborn care and to determine&#xD;
      trainees' satisfaction with the approaches in Ebonyi and Kogi states.&#xD;
&#xD;
      The specific objectives are to:&#xD;
&#xD;
        1. Compare knowledge and skill learning outcomes between the two groups of birth attendants&#xD;
           trained through the simulation-based LDHF/m-Mentoring versus group-based training&#xD;
           approaches in Kogi and Ebonyi states over 12-months.&#xD;
&#xD;
        2. Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and&#xD;
           group-based training approaches in improving skills of birth attendants in the selected&#xD;
           facilities in Kogi and Ebonyi state over 12-months.&#xD;
&#xD;
        3. Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training&#xD;
           approaches in improving skills of birth attendants in the selected facilities in Kogi&#xD;
           and Ebonyi state over 12-months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Simulation-based low dose high frequency (LDHF) training has emerged as a new strategy for&#xD;
      delivering key content and improving the competencies of health workers. In facility-based&#xD;
      driven simulation-based LDHF trainings, providers are not removed from clinical practice for&#xD;
      the extended periods of time, and a heavy emphasis is placed on simulation with practice and&#xD;
      feedback.&#xD;
&#xD;
      The Maternal and Child Survival Program (MCSP) in Nigeria is working in selected health&#xD;
      facilities in Ebonyi and Kogi States to improve the quality of care received by mothers and&#xD;
      newborns on the day of birth using high-impact evidence-based lifesaving interventions. The&#xD;
      simulation-based LDHF/m-Mentoring evaluation comparing it to the traditional group-based&#xD;
      training will contribute to the body of knowledge on this approach.&#xD;
&#xD;
      The study design is cluster randomized control trial. Sixty (60) health facilities will be&#xD;
      selected from the list of 120 facilities which are supported by MCSP and randomized to&#xD;
      intervention and control group. Selection will be based on caseload, level of service&#xD;
      delivery, and ownership. Thereafter, these will be randomly assigned to simulation-based&#xD;
      LDHF/m-Mentoring Group (intervention arm) or Group-Based Training Group (control arm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2016</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 24, 2017</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>Cluster randomized control trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The assessors will blinded with respect to which study arm the participants (health care workers) were assigned to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in competency in basic obstetric and emergency care between the groups</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of competent providers who retain clinical competency skills 3 months post-training</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of retention of skills between the two study arms</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of service providers who retain clinical competency skills after 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of satisfaction of service providers</measure>
    <time_frame>12 months</time_frame>
    <description>Proportion of service providers who are satisfied with the training approach</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of cost-effectiveness of the two approaches</measure>
    <time_frame>12 months</time_frame>
    <description>Cost-effectiveness of LDHF/m-Mentoring compared to group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi states.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">299</enrollment>
  <condition>Training</condition>
  <condition>Capacity Building</condition>
  <condition>Satisfaction</condition>
  <arm_group>
    <arm_group_label>LDHF plus m-Mentoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo pre-training assessment comprising multiple-choice questions and objective structured clinical examination (OSCE) using manikins. Training is divided into two 4-day &quot;low-dose&quot; sessions at the health facility or onsite training. Pre-training and immediate post-training assessments results will be compared. A score of ≥80% is acceptable competence (pass). During the one-month intervals between training sessions, participants practice using manikins to reinforce their competencies through simulation-based practices, facilitated by facility-based trained Peer Practice Coordinators (PPCs). The PPCs will also receive structured, monthly half-hour mentoring calls that will provide remote support, answering questions, providing guidance and reinforcing key messages. Acquisition of knowledge and clinical skills is measured.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The health providers will receive the same content of training in eight days, Off-site training, the way it's currently done in Nigeria. Both theoretical and practical through use of manikins - simulation. No reinforcement and further practice will take place once the participants are back in their work stations. Acquisition of knowledge and clinical skills is measured.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acquisition of Knowledge and clinical skills</intervention_name>
    <description>LDHF is a novel training approach that is being compared to the traditional training approach</description>
    <arm_group_label>LDHF plus m-Mentoring</arm_group_label>
    <arm_group_label>Traditional training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Onsite training</intervention_name>
    <description>Participants are training at their health facilities</description>
    <arm_group_label>LDHF plus m-Mentoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Off-site training</intervention_name>
    <description>Participants from different health facilities are gathered together in a central location for training, away from their workplaces</description>
    <arm_group_label>Traditional training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must give informed consent to participate in the study;&#xD;
&#xD;
          2. Must have spent at least six months in maternal and/or newborn care services;&#xD;
&#xD;
          3. Must be providing services related to maternal and newborn health in selected health&#xD;
             facilities at the time of the interview;&#xD;
&#xD;
          4. Must be available to participate in the training from the beginning to the end; and&#xD;
&#xD;
          5. Must have had pre-service training not incorporating simulation-based LDHF approach&#xD;
             from accredited medical schools, schools of nursing/midwifery or health technology.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Decides to opt out / declines to participate.&#xD;
&#xD;
          2. Has had prior training using the simulation-based LDHF approach.&#xD;
&#xD;
          3. Provides services related to maternal and newborn health more than one health facility&#xD;
             selected as part of intervention or comparison group.&#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>Emmanuel Otolorin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jhpiego</affiliation>
  </overall_official>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The study protocol will be shared through publication in a peer-reviewed journal.&#xD;
De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have access.</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/NCT03269240
org study id: IRB00007196
nct id: NCT03269240
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the effectiveness and cost of a simulation-based low dose
      high frequency (LDHF) plus m-Mentoring training versus the traditional group-based training
      approaches in improving knowledge and skill in maternal and newborn care and to determine
      trainees' satisfaction with the approaches in Ebonyi and Kogi states.

      The specific objectives are to:

        1. Compare knowledge and skill learning outcomes between the two groups of birth attendants
           trained through the simulation-based LDHF/m-Mentoring versus group-based training
           approaches in Kogi and Ebonyi states over 12-months.

        2. Assess the trainees' satisfaction with a simulation-based LDHF/m-Mentoring and
           group-based training approaches in improving skills of birth attendants in the selected
           facilities in Kogi and Ebonyi state over 12-months.

        3. Determine the cost and cost-effectiveness of LDHF/m-Mentoring and group-based training
           approaches in improving skills of birth attendants in the selected facilities in Kogi
           and Ebonyi state over 12-months.
Simulation-based low dose high frequency (LDHF) training has emerged as a new strategy for
      delivering key content and improving the competencies of health workers. In facility-based
      driven simulation-based LDHF trainings, providers are not removed from clinical practice for
      the extended periods of time, and a heavy emphasis is placed on simulation with practice and
      feedback.

      The Maternal and Child Survival Program (MCSP) in Nigeria is working in selected health
      facilities in Ebonyi and Kogi States to improve the quality of care received by mothers and
      newborns on the day of birth using high-impact evidence-based lifesaving interventions. The
      simulation-based LDHF/m-Mentoring evaluation comparing it to the traditional group-based
      training will contribute to the body of knowledge on this approach.

      The study design is cluster randomized control trial. Sixty (60) health facilities will be
      selected from the list of 120 facilities which are supported by MCSP and randomized to
      intervention and control group. Selection will be based on caseload, level of service
      delivery, and ownership. Thereafter, these will be randomly assigned to simulation-based
      LDHF/m-Mentoring Group (intervention arm) or Group-Based Training Group (control arm).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomized control trial
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: The assessors will blinded with respect to which study arm the participants (health care workers) were assigned to.
measure: Percent change in competency in basic obstetric and emergency care between the groups
time frame: 3 months
description: Proportion of competent providers who retain clinical competency skills 3 months post-training
measure: Comparison of retention of skills between the two study arms
time frame: 12 months
description: Proportion of service providers who retain clinical competency skills after 12 months
measure: Level of satisfaction of service providers
time frame: 12 months
description: Proportion of service providers who are satisfied with the training approach
measure: Comparison of cost-effectiveness of the two approaches
time frame: 12 months
description: Cost-effectiveness of LDHF/m-Mentoring compared to group-based training approaches in improving skills of birth attendants in the selected facilities in Kogi and Ebonyi states.
arm group label: LDHF plus m-Mentoring
arm group type: Experimental
description: Participants will undergo pre-training assessment comprising multiple-choice questions and objective structured clinical examination (OSCE) using manikins. Training is divided into two 4-day "low-dose" sessions at the health facility or onsite training. Pre-training and immediate post-training assessments results will be compared. A score of ≥80% is acceptable competence (pass). During the one-month intervals between training sessions, participants practice using manikins to reinforce their competencies through simulation-based practices, facilitated by facility-based trained Peer Practice Coordinators (PPCs). The PPCs will also receive structured, monthly half-hour mentoring calls that will provide remote support, answering questions, providing guidance and reinforcing key messages. Acquisition of knowledge and clinical skills is measured.
arm group label: Traditional training
arm group type: Active Comparator
description: The health providers will receive the same content of training in eight days, Off-site training, the way it's currently done in Nigeria. Both theoretical and practical through use of manikins - simulation. No reinforcement and further practice will take place once the participants are back in their work stations. Acquisition of knowledge and clinical skills is measured.
intervention type: Behavioral
intervention name: Acquisition of Knowledge and clinical skills
description: LDHF is a novel training approach that is being compared to the traditional training approach
arm group label: LDHF plus m-Mentoring
arm group label: Traditional training
intervention type: Other
intervention name: Onsite training
description: Participants are training at their health facilities
arm group label: LDHF plus m-Mentoring
intervention type: Other
intervention name: Off-site training
description: Participants from different health facilities are gathered together in a central location for training, away from their workplaces
arm group label: Traditional training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Otolorin
role: Principal Investigator
affiliation: Jhpiego
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: The study protocol will be shared through publication in a peer-reviewed journal.
De-identified participant data will be submitted to a data repository in accordance with the USAID policy where other researchers will have access.