<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/NCT03817229</url>
  </required_header>
  <id_info>
    <org_study_id>FP00001781</org_study_id>
    <secondary_id>R01NR017794-01A1</secondary_id>
    <nct_id>NCT03817229</nct_id>
  </id_info>
  <brief_title>Epilepsy Adherence in Children and Technology (eACT)</brief_title>
  <acronym>eACT</acronym>
  <official_title>Fostering Medication Adherence in Children With Epilepsy Using mHealth Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Orange County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Carolina State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</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>
      Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs&#xD;
      (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of&#xD;
      life, and high healthcare costs. Evidence-based adherence interventions are lacking and&#xD;
      critically needed, especially for children with epilepsy, who represent an underserved&#xD;
      population in pediatrics. The current proposal is a mHealth sequential, multiple assignment,&#xD;
      randomized trial (SMART) focused on providing education, automated digital reminders, and&#xD;
      individualized adherence feedback, as well as teaching problem-solving skills, with the goal&#xD;
      of improving adherence and quality of life and decreasing seizures and health care&#xD;
      utilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have&#xD;
      some level of non-adherence) for young children with newly diagnosed epilepsy, with&#xD;
      potentially devastating consequences. AED non-adherence is associated with a 3-fold increased&#xD;
      risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher&#xD;
      health care utilization and costs. One of the primary barriers to adherence is forgetting,&#xD;
      which may be particularly amenable to mHealth (mobile technology in healthcare)&#xD;
      interventions. Despite the critical need to develop and implement interventions to improve&#xD;
      adherence, there are few family-based interventions for young children with epilepsy and&#xD;
      their families. One existing intervention is highly promising; however, this intervention&#xD;
      requires six in-person sessions, which can be impossible for families who lack routine access&#xD;
      to tertiary specialty care due to time, financial, or transportation constraints. Thus, unmet&#xD;
      medical and psychosocial needs of the underserved pediatric epilepsy population are&#xD;
      perpetuated and compounded by limited access to this state of the art care. The overall goal&#xD;
      is to test a mHealth adherence intervention that is easily accessible using a stepped up care&#xD;
      model based on individual needs. This stepped up care model will conserve patient, family,&#xD;
      and provider time, costs and resources. The aim of this multi-site R01 is to conduct a&#xD;
      two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the&#xD;
      effectiveness of mHealth intervention strategies for improving AED adherence in caregivers of&#xD;
      young children with epilepsy. A two-month baseline period will be followed by two stages. In&#xD;
      Stage 1 (3-months long), non-adherent caregivers (&lt; 95%) will be randomized to a mHealth&#xD;
      education module and automated digital reminders (control) or the mHealth education module,&#xD;
      automated digital reminders, and individualized adherence feedback based on real-time&#xD;
      adherence monitoring (treatment) to address the primary barrier of forgetting. At the&#xD;
      beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve&#xD;
      adherence &gt; 95% (response) by the end of Stage 1 will be re-randomized to either continued&#xD;
      individualized adherence feedback or individualized adherence feedback augmented with two&#xD;
      mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.&#xD;
      Thus, there are three intervention strategies embedded in this SMART: #1 control, #2&#xD;
      treatment, and #3 problem-solving augmented treatment if nonresponsive at three months. The&#xD;
      primary outcome is electronically-monitored adherence and secondary outcomes include seizure&#xD;
      severity/frequency, quality of life, and healthcare utilization. If the aims of the project&#xD;
      are achieved, this study would have a large impact on pediatric epilepsy, with the potential&#xD;
      to change clinical practice for treating non-adherence. The SMART design would allow the&#xD;
      investigators to identify patients who are most likely to respond to interventions and step&#xD;
      up care with more time- and resource-intensive interventions (i.e., problem-solving with a&#xD;
      therapist via the web), when necessary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>
    <intervention_model_description>This a 2-stage, sequential, multiple assignment, randomized trial (SMART) . In Stage 1 (three months long), non-adherent caregivers (&lt; 95%) will be randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting. At the beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence &gt; 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with three mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
    <masking_description>The PI will not be notified of group status or details of participants. The healthcare provider will also not know which group participants are randomized to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence rates</measure>
    <time_frame>Month 8</time_frame>
    <description>Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence rates</measure>
    <time_frame>Month 14</time_frame>
    <description>Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence rates</measure>
    <time_frame>Month 20</time_frame>
    <description>Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in seizure frequency</measure>
    <time_frame>Months 8-14</time_frame>
    <description>Change in seizure frequency will be measured via parent-report and medical chart review. Change in seizure frequency will be calculated based on the number of seizures experienced in months 8-14 of the study compared to the 6-month baseline seizure frequency data. Seizure freedom will be a dichotomous variable (yes or no) and based on whether any type of seizure was experienced by the participant in months 8-14.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PedsQL Epilepsy Module (health-related quality of life measure)</measure>
    <time_frame>Month 14</time_frame>
    <description>The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare utilization (the number of emergency room visits and hospitalizations)</measure>
    <time_frame>Months 8-20</time_frame>
    <description>Based on medical chart review and parent report, the total number of emergency room visits and hospitalizations will be counting from Months 8-20 of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>mHealth education module and automated digital reminders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mHealth education module, automated digital reminders, and individualized adherence feedback (stage 1 SMART). After three months of intervention, the treatment group will be evaluated for responsiveness (&gt; 95%) based on the 30-day adherence outcome (stage 2 SMART). If participants in the treatment group demonstrate adherence &gt; 95%, they will continue with the treatment arm of receiving automated digital reminders and individualized adherence feedback. If they are deemed to be non-responsive (adherence &lt; 95%), they will be re-randomized to either: 1) continued automated digital reminders and individualized adherence feedback or 2) a mHealth problem solving module with three therapist-guided problem-solving sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education microlearning sessions</intervention_name>
    <description>mHealth education microlearning sessions</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Automated digital reminders</intervention_name>
    <description>reminders from electronic monitors based on texts or lights/chimes</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Problem-solving mHealth module</intervention_name>
    <description>mhealht problem solving module with 2 telehealth sessions with a therapist</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individualized Adherence Feedback Report</intervention_name>
    <description>Individual Adherence Feedback reports sent to parents weekly</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Children ages 2-12 years&#xD;
&#xD;
          2. Epilepsy diagnosis &lt; 2 years&#xD;
&#xD;
          3. Ability to read/speak English&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Major comorbid neurodevelopmental or medical disorders (e.g., Autism, diabetes)&#xD;
&#xD;
          2. Plan to wean AEDs for 18 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avani Modi, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Avani Modi, Ph.D.</last_name>
    <phone>513-636-4864</phone>
    <email>avani.modi@cchmc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leigh Ann Chamberlin</last_name>
    <phone>(513) 636-9739</phone>
    <email>LeighAnn.Chamberlin@cchmc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Childrens Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Heather Huszti, Ph.D.</last_name>
      <phone>714-509-8481</phone>
      <email>hhuszti@choc.org</email>
    </contact>
  </location>
  <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>Avani Modi, Ph.D.</last_name>
      <phone>513-636-4864</phone>
      <email>avani.modi@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Avani C Modi, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anup Patel, MD</last_name>
      <phone>614-722-4625</phone>
      <email>anup.patel@nationwidechildrens.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janelle Wagner, Ph.D.</last_name>
      <phone>843-792-3307</phone>
      <email>wagnerjl@musc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>adherence</keyword>
  <keyword>mHealth</keyword>
  <keyword>eHealth</keyword>
  <keyword>children</keyword>
  <keyword>caregivers</keyword>
  <keyword>compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Prior to sharing, all data will be de-identified in a HIPAA-compliant fashion. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. All modalities of data will be shared, including raw and aggregate data. Descriptors for all variables shared will be included to prevent misuse or confusion. Any analytical methods utilized to assess the data will be defined in shared formats. In addition, treatment manuals related to problem-solving and mHealth modules will also be shared after completion of the trial for future use.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>12 months after completion of the study</ipd_time_frame>
    <ipd_access_criteria>Requested from the PI</ipd_access_criteria>
  </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/NCT03817229
org study id: FP00001781
secondary id: R01NR017794-01A1
nct id: NCT03817229
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs
      (AEDs) as prescribed, which is associated with continued seizures, mortality, poor quality of
      life, and high healthcare costs. Evidence-based adherence interventions are lacking and
      critically needed, especially for children with epilepsy, who represent an underserved
      population in pediatrics. The current proposal is a mHealth sequential, multiple assignment,
      randomized trial (SMART) focused on providing education, automated digital reminders, and
      individualized adherence feedback, as well as teaching problem-solving skills, with the goal
      of improving adherence and quality of life and decreasing seizures and health care
      utilization.
Non-adherence to antiepileptic drugs (AEDs) is a common problem (i.e., 58% of patients have
      some level of non-adherence) for young children with newly diagnosed epilepsy, with
      potentially devastating consequences. AED non-adherence is associated with a 3-fold increased
      risk of seizures, poor quality of life, inaccurate clinical decision-making, and higher
      health care utilization and costs. One of the primary barriers to adherence is forgetting,
      which may be particularly amenable to mHealth (mobile technology in healthcare)
      interventions. Despite the critical need to develop and implement interventions to improve
      adherence, there are few family-based interventions for young children with epilepsy and
      their families. One existing intervention is highly promising; however, this intervention
      requires six in-person sessions, which can be impossible for families who lack routine access
      to tertiary specialty care due to time, financial, or transportation constraints. Thus, unmet
      medical and psychosocial needs of the underserved pediatric epilepsy population are
      perpetuated and compounded by limited access to this state of the art care. The overall goal
      is to test a mHealth adherence intervention that is easily accessible using a stepped up care
      model based on individual needs. This stepped up care model will conserve patient, family,
      and provider time, costs and resources. The aim of this multi-site R01 is to conduct a
      two-stage, sequential, multiple assignment, randomized trial (SMART) to evaluate the
      effectiveness of mHealth intervention strategies for improving AED adherence in caregivers of
      young children with epilepsy. A two-month baseline period will be followed by two stages. In
      Stage 1 (3-months long), non-adherent caregivers (< 95%) will be randomized to a mHealth
      education module and automated digital reminders (control) or the mHealth education module,
      automated digital reminders, and individualized adherence feedback based on real-time
      adherence monitoring (treatment) to address the primary barrier of forgetting. At the
      beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve
      adherence > 95% (response) by the end of Stage 1 will be re-randomized to either continued
      individualized adherence feedback or individualized adherence feedback augmented with two
      mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.
      Thus, there are three intervention strategies embedded in this SMART: #1 control, #2
      treatment, and #3 problem-solving augmented treatment if nonresponsive at three months. The
      primary outcome is electronically-monitored adherence and secondary outcomes include seizure
      severity/frequency, quality of life, and healthcare utilization. If the aims of the project
      are achieved, this study would have a large impact on pediatric epilepsy, with the potential
      to change clinical practice for treating non-adherence. The SMART design would allow the
      investigators to identify patients who are most likely to respond to interventions and step
      up care with more time- and resource-intensive interventions (i.e., problem-solving with a
      therapist via the web), when necessary.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This a 2-stage, sequential, multiple assignment, randomized trial (SMART) . In Stage 1 (three months long), non-adherent caregivers (< 95%) will be randomized to a mHealth education module and automated digital reminders (control) or the mHealth education module, automated digital reminders, and individualized adherence feedback based on real-time adherence monitoring (treatment) to address the primary barrier of forgetting. At the beginning of Stage 2 (two months long), caregivers randomized to treatment who do not achieve adherence > 95% (response) by the end of Stage 1 will be re-randomized to either continued individualized adherence feedback or individualized adherence feedback augmented with three mHealth problem-solving modules (translated from the PIs existing RCTs) with a therapist.
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
masking description: The PI will not be notified of group status or details of participants. The healthcare provider will also not know which group participants are randomized to.
measure: Adherence rates
time frame: Month 8
description: Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.
measure: Adherence rates
time frame: Month 14
description: Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.
measure: Adherence rates
time frame: Month 20
description: Electronically monitored adherence, as measured by the Simplemed+ pillboxes or Adheretech bottles will be used as the primary outcome. Daily adherence will be used to calculate adherence over one month intervals throughout the study. Month 8 will serve as the post-treatment outcome while Month 14 and 20 will serve as the short and long-term outcomes.
measure: Change in seizure frequency
time frame: Months 8-14
description: Change in seizure frequency will be measured via parent-report and medical chart review. Change in seizure frequency will be calculated based on the number of seizures experienced in months 8-14 of the study compared to the 6-month baseline seizure frequency data. Seizure freedom will be a dichotomous variable (yes or no) and based on whether any type of seizure was experienced by the participant in months 8-14.
measure: PedsQL Epilepsy Module (health-related quality of life measure)
time frame: Month 14
description: The Pediatric Quality of Life (PedsQL) Epilepsy Module is a 29-item epilepsy-specific HRQOL measure for youth with epilepsy between the ages of 2 and 18 years with excellent reliability and validity. A total of five different subscales comprise this measure, including Cognitive, Impact, Sleep, Executive Functioning, and Mood/Behavior. Parallel and developmentally appropriate forms exist for both youth and their caregiver, who record their answers using a 5-point Likert scale ranging from 0 = never a problem to 4 = almost always a problem. Scores range from 0-100, with higher scores representing better HRQOL. Internal consistency for the subscales range from 0.70 to 0.94.
measure: Healthcare utilization (the number of emergency room visits and hospitalizations)
time frame: Months 8-20
description: Based on medical chart review and parent report, the total number of emergency room visits and hospitalizations will be counting from Months 8-20 of the study.
arm group label: Control Group
arm group type: Active Comparator
description: mHealth education module and automated digital reminders
arm group label: Treatment Group
arm group type: Experimental
description: mHealth education module, automated digital reminders, and individualized adherence feedback (stage 1 SMART). After three months of intervention, the treatment group will be evaluated for responsiveness (> 95%) based on the 30-day adherence outcome (stage 2 SMART). If participants in the treatment group demonstrate adherence > 95%, they will continue with the treatment arm of receiving automated digital reminders and individualized adherence feedback. If they are deemed to be non-responsive (adherence < 95%), they will be re-randomized to either: 1) continued automated digital reminders and individualized adherence feedback or 2) a mHealth problem solving module with three therapist-guided problem-solving sessions.
intervention type: Behavioral
intervention name: Education microlearning sessions
description: mHealth education microlearning sessions
arm group label: Control Group
arm group label: Treatment Group
intervention type: Behavioral
intervention name: Automated digital reminders
description: reminders from electronic monitors based on texts or lights/chimes
arm group label: Control Group
arm group label: Treatment Group
intervention type: Behavioral
intervention name: Problem-solving mHealth module
description: mhealht problem solving module with 2 telehealth sessions with a therapist
arm group label: Treatment Group
intervention type: Behavioral
intervention name: Individualized Adherence Feedback Report
description: Individual Adherence Feedback reports sent to parents weekly
arm group label: Treatment Group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Avani Modi, Ph.D.
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
last name: Avani Modi, Ph.D.
phone: 513-636-4864
email: avani.modi@cchmc.org
last name: Leigh Ann Chamberlin
phone: (513) 636-9739
email: LeighAnn.Chamberlin@cchmc.org
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Epilepsy
sharing ipd: Yes
ipd description: Prior to sharing, all data will be de-identified in a HIPAA-compliant fashion. Data sets will be carefully reviewed to make sure that information such as age and gender cannot be used to gather additional information that could potentially identify individual subjects. All modalities of data will be shared, including raw and aggregate data. Descriptors for all variables shared will be included to prevent misuse or confusion. Any analytical methods utilized to assess the data will be defined in shared formats. In addition, treatment manuals related to problem-solving and mHealth modules will also be shared after completion of the trial for future use.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: 12 months after completion of the study
ipd access criteria: Requested from the PI