xml: <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/NCT06002243</url>
    </required_header>
    <id_info>
      <org_study_id>APP2015869</org_study_id>
      <nct_id>NCT06002243</nct_id>
    </id_info>
    <brief_title>Non-Expert Acquisition &amp; Remote Expert Review of Screening Echocardiography Images From Child Health &amp; AnteNatal Clinics</brief_title>
    <acronym>NEARER SCAN</acronym>
    <official_title>Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Menzies School of Health Research</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The University of Western Australia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Telethon Kids Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Western Australian Country Health Service</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Northern Territory Government of Australia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Timor-Leste Ministry of Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Miwatj Health Aboriginal Corporation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mala'la Health Service Aboriginal Corporation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Pilbara Aboriginal Health Alliance</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Menzies School of Health Research</source>
    <oversight_info>
      <has_dmc>Yes</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 Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from&#xD;
        Child health and AnteNatal clinics (NEARER SCAN) study is a co-designed, implementation&#xD;
        research project that will improve equitable access to culturally safe, best quality care for&#xD;
        Rheumatic Heart Disease (RHD) in high-burden Aboriginal and Torres Strait Islander&#xD;
        communities in Australia, and in Timor-Leste. The research addresses an area of unmet need,&#xD;
        using novel technologies and embedding them in health practice, to enhance and accelerate&#xD;
        diagnosis of RHD outside acute health settings and improve outcomes. The study will be&#xD;
        conducted in partnership with community leaders and local partners.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study titled 'Non-Expert Acquisition and Remote Expert Review of Screening&#xD;
        echocardiography images from Child health and AnteNatal clinics' (NEARER SCAN; &quot;LENO BESIK&quot;&#xD;
        in Tetum) aims to co-design, implement and evaluate a task-sharing approach to&#xD;
        echocardiographic screening for early detection and management of rheumatic heart disease&#xD;
        (RHD) in high-risk settings in Australia and Timor-Leste.&#xD;
  &#xD;
        Specific objectives include:&#xD;
  &#xD;
          1. To co-design implementation strategies with communities underpinned by local program&#xD;
             theories.&#xD;
  &#xD;
          2. To implement SPLASH echocardiography training and a task-sharing approach to&#xD;
             echocardiographic screening for early detection and management of RHD in communities,&#xD;
             based on co-designed implementation strategies.&#xD;
  &#xD;
          3. To conduct a realist evaluation to understand what implementation strategies assist in&#xD;
             integrating this intervention into routine health service delivery and why.&#xD;
  &#xD;
          4. To determine the clinical effectiveness of the intervention in terms of impact on key&#xD;
             clinical outcome measures.&#xD;
  &#xD;
          5. To conduct cost-of-illness, cost-effectiveness and budget-impact analyses of the&#xD;
             task-sharing approach to echocardiographic screening for early detection and management&#xD;
             of RHD in Australia and Timor-Leste.&#xD;
  &#xD;
        Local primary health clinic staff will be trained to perform focused echocardiography using&#xD;
        hand-carried ultrasound (HCU) devices employing the 'Single Parasternal Long Axis view with a&#xD;
        Sweep of the Heart' (SPLASH) technique. The acquired images will be interpreted by experts&#xD;
        (cardiologists and cardiac sonographers) remotely from the site of acquisition. Approximately&#xD;
        1500 children and pregnant women will be screened across high-risk communities in Australia&#xD;
        and Timor Leste, over an 18 month period.&#xD;
  &#xD;
        A mixed-methods effectiveness-implementation study design will be used to evaluate the&#xD;
        implementation of an intervention designed to achieve early detection and management of RHD&#xD;
        in high-risk populations. An implementation strategy will be co-designed at each site with&#xD;
        the local community and participating primary healthcare (PHC) service, incorporating&#xD;
        non-adaptable elements of the intervention, and mapped onto a Theory of Change framework.&#xD;
        Co-design, implementation and evaluation will occur simultaneously, and a Type 2 hybrid&#xD;
        design study will be used to evaluate both the implementation strategies and the clinical&#xD;
        effectiveness of the intervention. The clinical effectiveness will be assessed as the change&#xD;
        in the proportion of the at-risk population that received secondary prophylaxis by the end of&#xD;
        the study compared to baseline. Program implementation will be evaluated with a realist&#xD;
        evaluation to explain under what circumstances the program is successfully integrated into&#xD;
        routine service delivery. Data informing evaluation will include numbers of normal, abnormal,&#xD;
        and uninterpretable SPLASH echocardiograms obtained, numbers of participants progressing&#xD;
        through the cascade of care, augmented by qualitative data from interviews conducted with&#xD;
        staff and participants, and costs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in proportion receiving secondary antibiotic prophylaxis</measure>
      <time_frame>18 months from commencement of study</time_frame>
      <description>The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Full echocardiogram following screening echocardiogram</measure>
      <time_frame>3 months from screening echocardiogram</time_frame>
      <description>Proportion of people with an abnormal or uninterpretable screening echocardiogram who get a full diagnostic echocardiogram within 3 months and receive a diagnosis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of people diagnosed with RHD who are retained in care</measure>
      <time_frame>18 months from commencement of study</time_frame>
      <description>Proportion of people diagnosed during study period with RHD who receive guideline-based care by local health service</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Secondary antibiotic prophylaxis prescription and adherence</measure>
      <time_frame>12 months from time of diagnosis or at end of the study (which ever is longer).</time_frame>
      <description>Proportion of people prescribed secondary prophylaxis who are achieving &gt;= 80% adherence in a 12 months period from time of diagnosis or the end of the study, whichever is longer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal morbidity and mortality outcomes</measure>
      <time_frame>Within 6 weeks of the individual's post-partum period</time_frame>
      <description>Description of maternal morbidity and mortality in pregnant women diagnosed with RHD on echocardiographic screening. This will be reported in absolute numbers and percentage of study population. Morbidity will include cardiac complications (heart failure, arrhythmia, aborted sudden cardiac death, acute myocardial infarction), need for obstetric intervention including emergency cesarean section, intensive care admission, other obstetric complications.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of rheumatic heart disease within the screened population</measure>
      <time_frame>18 months from commencement of study</time_frame>
      <description>Prevalence of RHD in screened population based on echocardiographic diagnosis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis</measure>
      <time_frame>18 months from commencement of study</time_frame>
      <description>Description of severity of RHD in screened population. This will include proportions of mild, moderate and severe valve disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neonatal morbidity and mortality outcomes</measure>
      <time_frame>Within 6 weeks post-partum</time_frame>
      <description>Description of neonatal morbidity and mortality outcomes for the pregnant women diagnosed with RHD. This will be reported as absolute numbers and percentage of study population. Morbidity will include need for admission to neonatal intensive care.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Rheumatic Heart Disease</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant receiving echocardiography screening.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>SPLASH echocardiography screening</intervention_name>
      <description>Screening echocardiogram performed by a briefly trained health worker with images reviewed off site by an expert cardiologist or cardiac sonographer to determine screening outcome. Screening outcome may include: screen positive, screen negative or uninterpretable images.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria in Australia:&#xD;
  &#xD;
            -  Any child between the age of 5 - 20 years old living in the participating community&#xD;
  &#xD;
            -  Pregnant women at high risk for RHD undergoing antenatal appointments or a hospital&#xD;
               admission will be invited to participate. High risk for RHD will be defined as being&#xD;
               from an area where RHD all-age prevalence is &gt;1/1000 RHD or acute rheumatic fever&#xD;
               incidence &gt;30/100,000 per year in 5-14-year-olds. For practical purposes, this means&#xD;
               Aboriginal women living in urban, rural or remote communities in northern Australia,&#xD;
               or immigrants from high-risk settings.&#xD;
  &#xD;
          Inclusion criteria for Timor-Leste:&#xD;
  &#xD;
            -  Any child between the age of 5-20 years old and any pregnant woman.&#xD;
  &#xD;
          Exclusion criteria for Australia and Timor-Leste:&#xD;
  &#xD;
            -  Women who are unable to consent due to physical, mental, or intellectual disability&#xD;
               will be excluded. Women and children with known existing cardiac disease will NOT be&#xD;
               excluded since evaluation of severity and change in severity during pregnancy will be&#xD;
               tracked, and data will inform the calculation of prevalence.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joshua R Francis, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Menzies School of Health Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Joshua R Francis, MBBS</last_name>
      <phone>+61423528381</phone>
      <email>josh.francis@menzies.edu.au</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>James A Marangou, MBBS</last_name>
      <phone>+61412277527</phone>
      <email>james.marangou@menzies.edu.au</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Menzies School of Health Research</investigator_affiliation>
      <investigator_full_name>Joshua Francis</investigator_full_name>
      <investigator_title>Senior Research Fellow</investigator_title>
    </responsible_party>
    <keyword>Echocardiography</keyword>
    <keyword>Task-sharing</keyword>
    <keyword>Aboriginal and Torres Strait Islander Peoples</keyword>
    <keyword>Pregnancy</keyword>
    <keyword>Children</keyword>
    <keyword>First Nation Peoples</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rheumatic Heart Disease</mesh_term>
      <mesh_term>Heart Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002243
  org study id: APP2015869
  nct id: NCT06002243
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from
        Child health and AnteNatal clinics (NEARER SCAN) study is a co-designed, implementation
        research project that will improve equitable access to culturally safe, best quality care for
        Rheumatic Heart Disease (RHD) in high-burden Aboriginal and Torres Strait Islander
        communities in Australia, and in Timor-Leste. The research addresses an area of unmet need,
        using novel technologies and embedding them in health practice, to enhance and accelerate
        diagnosis of RHD outside acute health settings and improve outcomes. The study will be
        conducted in partnership with community leaders and local partners.
  This study titled 'Non-Expert Acquisition and Remote Expert Review of Screening
        echocardiography images from Child health and AnteNatal clinics' (NEARER SCAN; "LENO BESIK"
        in Tetum) aims to co-design, implement and evaluate a task-sharing approach to
        echocardiographic screening for early detection and management of rheumatic heart disease
        (RHD) in high-risk settings in Australia and Timor-Leste.
  
        Specific objectives include:
  
          1. To co-design implementation strategies with communities underpinned by local program
             theories.
  
          2. To implement SPLASH echocardiography training and a task-sharing approach to
             echocardiographic screening for early detection and management of RHD in communities,
             based on co-designed implementation strategies.
  
          3. To conduct a realist evaluation to understand what implementation strategies assist in
             integrating this intervention into routine health service delivery and why.
  
          4. To determine the clinical effectiveness of the intervention in terms of impact on key
             clinical outcome measures.
  
          5. To conduct cost-of-illness, cost-effectiveness and budget-impact analyses of the
             task-sharing approach to echocardiographic screening for early detection and management
             of RHD in Australia and Timor-Leste.
  
        Local primary health clinic staff will be trained to perform focused echocardiography using
        hand-carried ultrasound (HCU) devices employing the 'Single Parasternal Long Axis view with a
        Sweep of the Heart' (SPLASH) technique. The acquired images will be interpreted by experts
        (cardiologists and cardiac sonographers) remotely from the site of acquisition. Approximately
        1500 children and pregnant women will be screened across high-risk communities in Australia
        and Timor Leste, over an 18 month period.
  
        A mixed-methods effectiveness-implementation study design will be used to evaluate the
        implementation of an intervention designed to achieve early detection and management of RHD
        in high-risk populations. An implementation strategy will be co-designed at each site with
        the local community and participating primary healthcare (PHC) service, incorporating
        non-adaptable elements of the intervention, and mapped onto a Theory of Change framework.
        Co-design, implementation and evaluation will occur simultaneously, and a Type 2 hybrid
        design study will be used to evaluate both the implementation strategies and the clinical
        effectiveness of the intervention. The clinical effectiveness will be assessed as the change
        in the proportion of the at-risk population that received secondary prophylaxis by the end of
        the study compared to baseline. Program implementation will be evaluated with a realist
        evaluation to explain under what circumstances the program is successfully integrated into
        routine service delivery. Data informing evaluation will include numbers of normal, abnormal,
        and uninterpretable SPLASH echocardiograms obtained, numbers of participants progressing
        through the cascade of care, augmented by qualitative data from interviews conducted with
        staff and participants, and costs.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Change in proportion receiving secondary antibiotic prophylaxis
  time frame: 18 months from commencement of study
  description: The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline
  measure: Full echocardiogram following screening echocardiogram
  time frame: 3 months from screening echocardiogram
  description: Proportion of people with an abnormal or uninterpretable screening echocardiogram who get a full diagnostic echocardiogram within 3 months and receive a diagnosis.
  measure: Proportion of people diagnosed with RHD who are retained in care
  time frame: 18 months from commencement of study
  description: Proportion of people diagnosed during study period with RHD who receive guideline-based care by local health service
  measure: Secondary antibiotic prophylaxis prescription and adherence
  time frame: 12 months from time of diagnosis or at end of the study (which ever is longer).
  description: Proportion of people prescribed secondary prophylaxis who are achieving >= 80% adherence in a 12 months period from time of diagnosis or the end of the study, whichever is longer.
  measure: Maternal morbidity and mortality outcomes
  time frame: Within 6 weeks of the individual's post-partum period
  description: Description of maternal morbidity and mortality in pregnant women diagnosed with RHD on echocardiographic screening. This will be reported in absolute numbers and percentage of study population. Morbidity will include cardiac complications (heart failure, arrhythmia, aborted sudden cardiac death, acute myocardial infarction), need for obstetric intervention including emergency cesarean section, intensive care admission, other obstetric complications.
  measure: Prevalence of rheumatic heart disease within the screened population
  time frame: 18 months from commencement of study
  description: Prevalence of RHD in screened population based on echocardiographic diagnosis
  measure: Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis
  time frame: 18 months from commencement of study
  description: Description of severity of RHD in screened population. This will include proportions of mild, moderate and severe valve disease.
  measure: Neonatal morbidity and mortality outcomes
  time frame: Within 6 weeks post-partum
  description: Description of neonatal morbidity and mortality outcomes for the pregnant women diagnosed with RHD. This will be reported as absolute numbers and percentage of study population. Morbidity will include need for admission to neonatal intensive care.
  arm group label: Intervention
  arm group type: Experimental
  description: Participant receiving echocardiography screening.
  intervention type: Diagnostic Test
  intervention name: SPLASH echocardiography screening
  description: Screening echocardiogram performed by a briefly trained health worker with images reviewed off site by an expert cardiologist or cardiac sonographer to determine screening outcome. Screening outcome may include: screen positive, screen negative or uninterpretable images.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joshua R Francis, MBBS
  role: Principal Investigator
  affiliation: Menzies School of Health Research
  last name: Joshua R Francis, MBBS
  phone: +61423528381
  email: josh.francis@menzies.edu.au
  last name: James A Marangou, MBBS
  phone: +61412277527
  email: james.marangou@menzies.edu.au
  responsible party type: Principal Investigator
  investigator affiliation: Menzies School of Health Research
  investigator full name: Joshua Francis
  investigator title: Senior Research Fellow
  mesh term: Rheumatic Heart Disease
  mesh term: Heart Diseases
  sharing ipd: No