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/NCT06003686</url>
    </required_header>
    <id_info>
      <org_study_id>20230202</org_study_id>
      <nct_id>NCT06003686</nct_id>
    </id_info>
    <brief_title>Spinal Cord Injury Model Systems (SCIMS) - Education Module</brief_title>
    <official_title>A Spinal Cord Injury (SCI) Stakeholder-vetted Education Module to Mitigate Early Cardioendocrine Health Risks Occurring After Spinal Cord Injuries.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Miami</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 purpose of this study is to find out if receiving education regarding increased risks of&#xD;
        cardiometabolic disease helps subjects understand these risks and how these risks&#xD;
        participants' health.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 31, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2025</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Effectiveness of education modules as determined in the Knowledge Test</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Effectiveness as determined by the number of correct answers on the Knowledge Test where the higher number of correct answers indicates increased knowledge of the information provided.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Body Weight as determined by kilograms (kg)</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Body weight will be measured in kilograms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Body composition will be measured in grams using DXA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Body composition will be expressed as a percentage of body fat (BF) using DXA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sugar metabolism as determined by Insulin resistance (IR)</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>Sugar metabolism will be determined as IR calculated using the formula (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity. Fasting values are obtained from blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from &quot;1- very satisfied&quot; to &quot;6-very dissatisfied&quot;. On the important section scoring ranges from &quot;1-very important&quot; to &quot;6- very unimportant&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set</measure>
      <time_frame>baseline, up to 6 months</time_frame>
      <description>QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in heart disease risk as determined by cholesterol</measure>
      <time_frame>baseline, up to 6 months.</time_frame>
      <description>Risk of heart disease will be measured from a blood sample in mg/dL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in heart disease risk as determined by blood pressure (BP)</measure>
      <time_frame>baseline, up to 6 months.</time_frame>
      <description>BP will be measured in mmHg using an arm cuff</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Obesity</condition>
    <condition>Cardiometabolic Syndrome</condition>
    <arm_group>
      <arm_group_label>Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>WebMD Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PVA Consumer Guide</intervention_name>
      <description>Subject's will receive education on the PVA consumer guide 3 times over the course of the study.&#xD;
  Each session will be approximately 10-15 minutes and will consist of a general review of the nutrition, exercise, and general healthy living guidelines content included.</description>
      <arm_group_label>Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>WebMD</intervention_name>
      <description>Subject's will receive education on how to navigate the WebMD site and find information on health, exercise and nutrition 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the health and wellness content available on the website. At study completion, subjects in this group will be provided with the PVA guide and a brief orientation of the nutrition, exercise, and general healthy living guidelines content included in the guide.</description>
      <arm_group_label>WebMD Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Men and Women with SCI/D aged 18-70 years.&#xD;
  &#xD;
            2. Neurologically complete and incomplete American Spinal Injury Association (ASIA)&#xD;
               Impairment scale (AIS) A-D spinal cord levels C5 and below.&#xD;
  &#xD;
            3. Enrolled no later than 4 months following discharge from initial rehabilitation from&#xD;
               SCI.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy determined by urine testing in sexually active females.&#xD;
  &#xD;
            2. Cognitive impairment that compromises the legitimacy of consent.&#xD;
  &#xD;
            3. Grade 3-4 pressure injury at the time of study entry.&#xD;
  &#xD;
            4. Prisoners&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mark Nash, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Patricia Graham, MS</last_name>
      <phone>3052435119</phone>
      <email>pgraham1@med.miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>MedStar National Rehabilitation Network</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Ana Aguirre</last_name>
        <phone>202-877-1875</phone>
        <email>AnaValeria.AguirreGuemez@medstar.net</email>
      </contact>
      <investigator>
        <last_name>Suzanne Groah, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Miami - Miami Project to Cure Paralysis</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Minnesota Rehabilitation</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carmen Terzic, MD</last_name>
        <phone>507-538-1580</phone>
        <email>terzic.carmen@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Leslie Morse, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Baylor Scott &amp; White Institute for Research</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75246</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacqueline Nguyen, MPH</last_name>
        <phone>469-831-5321</phone>
        <email>Jacqueline.Nguyen@BSWHealth.org</email>
      </contact>
      <investigator>
        <last_name>Simon Driver, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>McGuire Research Institute Richmond VA Medical Center</name>
        <address>
          <city>Richmond</city>
          <state>Virginia</state>
          <zip>23284-0667</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Refka Khalil</last_name>
        <email>refka.khalil@va.gov</email>
      </contact>
      <investigator>
        <last_name>Ashraf Gorgey, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Mark S. Nash, Ph.D., FACSM</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Metabolic Syndrome</mesh_term>
      <mesh_term>Wounds and Injuries</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/NCT06003686
  org study id: 20230202
  nct id: NCT06003686
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to find out if receiving education regarding increased risks of
        cardiometabolic disease helps subjects understand these risks and how these risks
        participants' health.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in Effectiveness of education modules as determined in the Knowledge Test
  time frame: baseline, up to 6 months
  description: Effectiveness as determined by the number of correct answers on the Knowledge Test where the higher number of correct answers indicates increased knowledge of the information provided.
  measure: Change in Body Weight as determined by kilograms (kg)
  time frame: baseline, up to 6 months
  description: Body weight will be measured in kilograms
  measure: Change in Body composition as determined by Dual X-ray Absorptiometry (DXA)
  time frame: baseline, up to 6 months
  description: Body composition will be measured in grams using DXA
  measure: Change in Body composition as determined by Dual X-ray Absorptiometry (DXA) in Percentage
  time frame: baseline, up to 6 months
  description: Body composition will be expressed as a percentage of body fat (BF) using DXA
  measure: Change in sugar metabolism as determined by Insulin resistance (IR)
  time frame: baseline, up to 6 months
  description: Sugar metabolism will be determined as IR calculated using the formula (fasting serum glucose*fasting serum insulin/22.5). Lower values indicate a higher degree of insulin sensitivity. Fasting values are obtained from blood samples
  measure: Change in Quality of Life (QoL) as measured by Quality Index Spinal Cord Injury Version III
  time frame: baseline, up to 6 months
  description: A composite score will be obtained to assess change in QoL using a six-point Likert scale. Scores for satisfaction section range from "1- very satisfied" to "6-very dissatisfied". On the important section scoring ranges from "1-very important" to "6- very unimportant"
  measure: Change in Quality of Life (QoL) Using the International Spinal Cord Injury Basic Data Set
  time frame: baseline, up to 6 months
  description: QoL values will be determined using a scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
  measure: Change in heart disease risk as determined by cholesterol
  time frame: baseline, up to 6 months.
  description: Risk of heart disease will be measured from a blood sample in mg/dL
  measure: Change in heart disease risk as determined by blood pressure (BP)
  time frame: baseline, up to 6 months.
  description: BP will be measured in mmHg using an arm cuff
  arm group label: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group
  arm group type: Experimental
  description: Hard paper copy of as well as an electronic copy of the guide will be provided to subjects and study staff will provide a general review of the contents of the guide with subjects during their education sessions. Participants will be in this group for 6 months.
  arm group label: WebMD Group
  arm group type: Active Comparator
  description: Subjects will be introduced to WebMD and its contents. A brief document will be provided that includes site summary and website. Study staff will provide a very brief overview of the site. Participants will be in this group for 6 months.
  intervention type: Behavioral
  intervention name: PVA Consumer Guide
  description: Subject's will receive education on the PVA consumer guide 3 times over the course of the study.
  Each session will be approximately 10-15 minutes and will consist of a general review of the nutrition, exercise, and general healthy living guidelines content included.
  arm group label: Paralyzed Veterans of America (PVA) Cardio-Metabolic Disease (CMD) Consumer Guide Group
  intervention type: Behavioral
  intervention name: WebMD
  description: Subject's will receive education on how to navigate the WebMD site and find information on health, exercise and nutrition 3 times over the course of the study. Each session will be approximately 10-15 minutes and will consist of a general review of the health and wellness content available on the website. At study completion, subjects in this group will be provided with the PVA guide and a brief orientation of the nutrition, exercise, and general healthy living guidelines content included in the guide.
  arm group label: WebMD Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Mark Nash, PhD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Patricia Graham, MS
  phone: 3052435119
  email: pgraham1@med.miami.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Mark S. Nash, Ph.D., FACSM
  investigator title: Principal Investigator
  mesh term: Spinal Cord Injuries
  mesh term: Metabolic Syndrome
  mesh term: Wounds and Injuries
  sharing ipd: No