<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/NCT03017755</url>
  </required_header>
  <id_info>
    <org_study_id>16-008212</org_study_id>
    <nct_id>NCT03017755</nct_id>
  </id_info>
  <brief_title>Scoliosis Survey to Development Treatment Decision Tool</brief_title>
  <official_title>Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and Their Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a survey to help understand the influences related to the decision for Adolescent&#xD;
      Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then&#xD;
      plans to create a decision aid to help families when making a decision about the treatment&#xD;
      choice being presented to them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This survey is designed to help understand the factors that families consider to help make&#xD;
      treatment decisions related to Adolescent Idiopathic Scoliosis (AIS). The surveys will then&#xD;
      be used to help create a shared decision making tool to help families better understand the&#xD;
      treatment options and optimize clinical conversations surrounding AIS treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 11, 2017</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects who completed the survey</measure>
    <time_frame>Baseline, approximately 3 years</time_frame>
    <description>Number of subjects who completed the survey</description>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Scoliosis; Adolescence</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey for Patients Treated for Scoliosis and ther Families</intervention_name>
    <description>Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and ther Families</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolecent Idiopathic Scoliosis (AIS) patients and their families&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject (and/or parent of subject) who has previously been treated for Adolescent&#xD;
             Idiopathic Scoliosis (AIS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than or equal to 12 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd A Milbrandt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Damian Paulson</last_name>
    <phone>507-293-6713</phone>
    <email>paulson.damian@mayo.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Pulido</last_name>
      <email>scoliosis@mayo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Todd A. Milbrandt, M.D.</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <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/NCT03017755
org study id: 16-008212
nct id: NCT03017755
lead sponsor: 
has dmc: No
This is a survey to help understand the influences related to the decision for Adolescent
      Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then
      plans to create a decision aid to help families when making a decision about the treatment
      choice being presented to them.
This survey is designed to help understand the factors that families consider to help make
      treatment decisions related to Adolescent Idiopathic Scoliosis (AIS). The surveys will then
      be used to help create a shared decision making tool to help families better understand the
      treatment options and optimize clinical conversations surrounding AIS treatment.
observational model: Cohort
time perspective: Prospective
measure: Number of subjects who completed the survey
time frame: Baseline, approximately 3 years
description: Number of subjects who completed the survey
intervention type: Other
intervention name: Survey for Patients Treated for Scoliosis and ther Families
description: Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and ther Families
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Todd A Milbrandt, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Damian Paulson
phone: 507-293-6713
email: paulson.damian@mayo.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Todd A. Milbrandt, M.D.
investigator title: MD
mesh term: Scoliosis
sharing ipd: No