<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/NCT01730235</url>
  </required_header>
  <id_info>
    <org_study_id>R18HS018168</org_study_id>
    <nct_id>NCT01730235</nct_id>
  </id_info>
  <brief_title>My MediHealth: A Paradigm for Children-centered Medication Management</brief_title>
  <acronym>mymedihealth</acronym>
  <official_title>My MediHealth: A Paradigm for Children-centered Medication Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The last mile of the medication use system requires tools to help patients comply with&#xD;
      medication administration rules and monitor for side effects. Personal health records (PHR)&#xD;
      and emerging user-adopted communication tools promise to change the landscape of medication&#xD;
      management. The overarching goal of the MyMediHealth project is to investigate ways in which&#xD;
      PHRs and supported applications can improve the safety and quality of medication delivery.&#xD;
      Preliminary work in this area by a team of parents, patients and school/clinic health&#xD;
      providers created a vision for MyMediHealth, a next-generation medication management system.&#xD;
      MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure&#xD;
      safe and effective medication delivery. This vision featured just-in-time medication&#xD;
      reminders to children with special health care needs, two-way communication to log when doses&#xD;
      have been administered or when side effects have occurred, and mechanisms to warn caregivers&#xD;
      about side effects and drug interactions. However, much of this work was done using&#xD;
      prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried&#xD;
      out without significant changes in processes and policies, the purpose of this proposed study&#xD;
      is to evaluate the impact of medication management tools such as MyMediHealth on medication&#xD;
      adherence for children with chronic illnesses. Specifically, the investigators hypothesize&#xD;
      that compared with usual practice, children using mymedihealth will have improved medication&#xD;
      adherence and will report improved (decreased) asthma symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline asthma self efficacy after 3 weeks</measure>
    <time_frame>participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.</time_frame>
    <description>Will assess self-efficacy using the survey by Bursch and colleagues (1997)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in medication adherence after 3 weeks</measure>
    <time_frame>Participants will be followed for 4 weeks, with measurements at baseline and the end of 3 weeks</time_frame>
    <description>At the end of the 2-week data collection period (following the 1-week test period), all participants (Control and Intervention) and their parents will be asked to complete a brief online survey, including the Asthma Control Test (ACT) and the weekly adherence survey(SDSCA). All responses collected from participants and their parents in the Time 2 Survey will be compared to those collected from the Baseline Survey, where applicable. Medication adherence will be measured by responses to ACT and SDSCA survey items for all participants.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">115</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Case Group</arm_group_label>
    <description>Group receiving access to MyMediHealth web site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Children completing baseline and week two measures, but without any additional intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MyMediHealth access</intervention_name>
    <description>Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at&#xD;
        least one daily medication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Access to the internet Caregiver agrees to let child use the Internet for the project&#xD;
             Internet service working properly Legal guardian approves of study Child with her or&#xD;
             his own cell phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non English or spanish speaking family&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vandebilt Monroe Carell Children's Hospital</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 14, 2012</last_update_submitted>
  <last_update_submitted_qc>November 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Kevin Johnson</investigator_full_name>
    <investigator_title>Professor and Chair, Biomedical Informatics</investigator_title>
  </responsible_party>
  <!-- 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/NCT01730235
org study id: R18HS018168
nct id: NCT01730235
lead sponsor: 
has dmc: No
The last mile of the medication use system requires tools to help patients comply with
      medication administration rules and monitor for side effects. Personal health records (PHR)
      and emerging user-adopted communication tools promise to change the landscape of medication
      management. The overarching goal of the MyMediHealth project is to investigate ways in which
      PHRs and supported applications can improve the safety and quality of medication delivery.
      Preliminary work in this area by a team of parents, patients and school/clinic health
      providers created a vision for MyMediHealth, a next-generation medication management system.
      MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure
      safe and effective medication delivery. This vision featured just-in-time medication
      reminders to children with special health care needs, two-way communication to log when doses
      have been administered or when side effects have occurred, and mechanisms to warn caregivers
      about side effects and drug interactions. However, much of this work was done using
      prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried
      out without significant changes in processes and policies, the purpose of this proposed study
      is to evaluate the impact of medication management tools such as MyMediHealth on medication
      adherence for children with chronic illnesses. Specifically, the investigators hypothesize
      that compared with usual practice, children using mymedihealth will have improved medication
      adherence and will report improved (decreased) asthma symptoms.
observational model: Case-Control
time perspective: Prospective
measure: Change in baseline asthma self efficacy after 3 weeks
time frame: participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders.
description: Will assess self-efficacy using the survey by Bursch and colleagues (1997)
measure: Change in medication adherence after 3 weeks
time frame: Participants will be followed for 4 weeks, with measurements at baseline and the end of 3 weeks
description: At the end of the 2-week data collection period (following the 1-week test period), all participants (Control and Intervention) and their parents will be asked to complete a brief online survey, including the Asthma Control Test (ACT) and the weekly adherence survey(SDSCA). All responses collected from participants and their parents in the Time 2 Survey will be compared to those collected from the Baseline Survey, where applicable. Medication adherence will be measured by responses to ACT and SDSCA survey items for all participants.
arm group label: Case Group
description: Group receiving access to MyMediHealth web site.
arm group label: Control Group
description: Children completing baseline and week two measures, but without any additional intervention.
intervention type: Other
intervention name: MyMediHealth access
description: Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.
arm group label: Control Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Kevin Johnson
investigator title: Professor and Chair, Biomedical Informatics