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/NCT06023667</url>
    </required_header>
    <id_info>
      <org_study_id>SMART-IBD</org_study_id>
      <nct_id>NCT06023667</nct_id>
    </id_info>
    <brief_title>SMART-IBD App Trial</brief_title>
    <official_title>Self-Management Assistance for Recommended Treatement (SMART) App Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Children's Hospital Medical Center, Cincinnati</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Children's Hospital Medical Center, Cincinnati</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 objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in&#xD;
        improving medication adherence and self-management skills in adolescents with IBD. The&#xD;
        investigators will conduct a randomized control trial to compare a sample of 15 youth (ages&#xD;
        13-17) with IBD using an app that has educational content and medication reminders to 15&#xD;
        youth in an attention control group. The length of the intervention will include one month of&#xD;
        baseline adherence data collection, one month of intervention, and one month of&#xD;
        post-treatment adherence data collection.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 14, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only study coordinators will have access to the assignment of each participant.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Medication adherence</measure>
      <time_frame>3 months</time_frame>
      <description>Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <condition>IBD</condition>
    <condition>Crohn Disease</condition>
    <condition>Ulcerative Colitis</condition>
    <arm_group>
      <arm_group_label>SMART-IBD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Attention Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention and one month of diaries post-intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SMART-IBD</intervention_name>
      <description>Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.</description>
      <arm_group_label>SMART-IBD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis&#xD;
               (collectively IBD)&#xD;
  &#xD;
            -  Prescribed at least one medication used to treat IBD, regardless of route of&#xD;
               administration&#xD;
  &#xD;
            -  Access to internet or wi-fi or data plan and access to smartphone&#xD;
  &#xD;
            -  English fluency for patient and clinician&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of pervasive developmental disorder in patient or caregiver as determined by&#xD;
               medical chart review&#xD;
  &#xD;
            -  Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as&#xD;
               determined by medical chart review&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kevin Hommel, PhD</last_name>
      <phone>513-803-0407</phone>
      <email>kevin.hommel@cchmc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jessica King, BA</last_name>
      <phone>513-803-0920</phone>
      <email>jessica.king1@cchmc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cincinnati Children's Hospital Medical Center</name>
        <address>
          <city>Cincinnati</city>
          <state>Ohio</state>
          <zip>45229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kevin Hommel, PhD</last_name>
        <phone>513-803-0407</phone>
        <email>kevin.hommel@cchmc.org</email>
      </contact>
      <contact_backup>
        <last_name>Jessica King, BA</last_name>
        <phone>513-803-0920</phone>
        <email>jessica.king1@cchmc.org</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IBD</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT06023667
  org study id: SMART-IBD
  nct id: NCT06023667
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this trial is to test whether a smartphone app, SMART-IBD, is effective in
        improving medication adherence and self-management skills in adolescents with IBD. The
        investigators will conduct a randomized control trial to compare a sample of 15 youth (ages
        13-17) with IBD using an app that has educational content and medication reminders to 15
        youth in an attention control group. The length of the intervention will include one month of
        baseline adherence data collection, one month of intervention, and one month of
        post-treatment adherence data collection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only study coordinators will have access to the assignment of each participant.
  measure: Medication adherence
  time frame: 3 months
  description: Medication adherence will be measured using electronic monitoring of medications indicated being taken in the SMART-IBD app
  arm group label: SMART-IBD
  arm group type: Experimental
  description: The SMART-IBD app consists of educational content, medication reminders, and weekly app engagement challenges. App users will participate in weekly challenges that focus on topics such as adherence, sleep, and diary usage. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention, and one month of diaries post-intervention.
  arm group label: Attention Control
  arm group type: No Intervention
  description: Participants in this arm will not receive any intervention content. Participants in this arm will complete one month of run-in diaries, one month of diaries during intervention and one month of diaries post-intervention.
  intervention type: Behavioral
  intervention name: SMART-IBD
  description: Daily medication and diary completion reminders are provided to participants. Additional educational content regarding self-management skills will be provided.
  arm group label: SMART-IBD
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 17 Years
  healthy volunteers: No
  last name: Kevin Hommel, PhD
  phone: 513-803-0407
  email: kevin.hommel@cchmc.org
  last name: Jessica King, BA
  phone: 513-803-0920
  email: jessica.king1@cchmc.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Inflammatory Bowel Diseases