<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/NCT02970396</url>
  </required_header>
  <id_info>
    <org_study_id>12-14-07</org_study_id>
    <nct_id>NCT02970396</nct_id>
  </id_info>
  <brief_title>Self-management for People With Epilepsy and a History of Negative Health Events</brief_title>
  <acronym>SMART</acronym>
  <official_title>Self-management for People With Epilepsy and a History of Negative Health Events (SMART)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Western Reserve University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an investigation of adult individuals with epilepsy, and involves educational and&#xD;
      behavioral interventions intended to enhance treatment adherence and self-management.&#xD;
&#xD;
      The investigators are adapting a self-management intervention that they developed in a&#xD;
      previous study to individuals with epilepsy and a history of negative health events (NHEs),&#xD;
      such as accidents and emergency department (ED) visits, diminished quality of life and poor&#xD;
      mental well-being. The intervention &quot;Self-management for people with epilepsy and a history&#xD;
      of negative health events (SMART)&quot; is intended to reduce NHEs and improve quality of life in&#xD;
      people with epilepsy associated with historically disadvantaged groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of negative health events</measure>
    <time_frame>baseline, 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>SMART Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>self-management</intervention_name>
    <arm_group_label>SMART Intervention</arm_group_label>
    <arm_group_label>Wait-list</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of epilepsy&#xD;
&#xD;
          -  Negative health event within the last 6 months&#xD;
&#xD;
          -  Able to provide written consent and participate in study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immediate risk of self-harm&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Unable to read/understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Case Western Reserve University</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
    <investigator_full_name>Martha Sajatovic, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02970396
org study id: 12-14-07
nct id: NCT02970396
lead sponsor: 
has dmc: No
This is an investigation of adult individuals with epilepsy, and involves educational and
      behavioral interventions intended to enhance treatment adherence and self-management.

      The investigators are adapting a self-management intervention that they developed in a
      previous study to individuals with epilepsy and a history of negative health events (NHEs),
      such as accidents and emergency department (ED) visits, diminished quality of life and poor
      mental well-being. The intervention "Self-management for people with epilepsy and a history
      of negative health events (SMART)" is intended to reduce NHEs and improve quality of life in
      people with epilepsy associated with historically disadvantaged groups.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in number of negative health events
time frame: baseline, 6 months
arm group label: SMART Intervention
arm group type: Active Comparator
description: Participants (a total of 120 individuals) will be randomly assigned to either SMART (N=60) or the wait-list control (N= 60), in a 1:1 ratio.
arm group label: Wait-list
arm group type: Active Comparator
description: Participants assigned to the wait-list will start the SMART intervention 6 months following randomization.
intervention type: Behavioral
intervention name: self-management
arm group label: SMART Intervention
arm group label: Wait-list
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Case Western Reserve University
investigator full name: Martha Sajatovic, MD
investigator title: Professor
mesh term: Epilepsy