<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/NCT02197689</url>
  </required_header>
  <id_info>
    <org_study_id>NSC 99-2218-E-038-001</org_study_id>
    <nct_id>NCT02197689</nct_id>
  </id_info>
  <brief_title>A Trial for a Personalized Medication Management Platform to Improve Medication Adherence</brief_title>
  <official_title>Mobile Intelligent Personal Medication Management Platform</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Chung Cheng University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Tsing Hua University, HsinChu City, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Taiwan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hwa Hsia Institute of Technology, New Taipei City, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Taiwan has attracted much attention for its National Health Insurance (NHI) and healthcare&#xD;
      system around the world with many countries in Europe and the United States using it as a&#xD;
      benchmark. However, increasing medication costs over the past two years account for more than&#xD;
      25% of total expenditure, surpassing every OECD member and mounting increasing pressure on&#xD;
      the NHI. Nevertheless, patient medication adherence is relatively low. Thus, the&#xD;
      investigators assessed the effectiveness of a personalized medication management system for&#xD;
      improving the medication adherence for patients, in order to save long term medication costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design, Setting and Patients: The investigators developed a mobile personalized medication&#xD;
      management platform (PMMP) to reduce delayed and missed medications. The investigators&#xD;
      conducted a randomized control trial in medical centers of northern Taiwan from January 2010&#xD;
      to July 2012 using 1198 participants that missed or delayed their medications during past&#xD;
      three days. They received a minimum 7-day to 14-day maximum medication prescription.&#xD;
&#xD;
      Interventions: Patients were randomized into a control group which non-received any SMS&#xD;
      reminder for medication using and an intervention group which received a SMS reminder&#xD;
      everyday in mobile devices.&#xD;
&#xD;
      Primary Outcome(s) and Measure(s): The primary outcomes were compared patient medication&#xD;
      adherence among experimental and control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients in delaying and forgetting medications</measure>
    <time_frame>Patients who participated in this trial will be sent SMS during 7days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">763</enrollment>
  <condition>Patients Take Medicine</condition>
  <arm_group>
    <arm_group_label>SMS Medication Reminder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>763 patients were assigned to experimental group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No SMS Reminder</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>435 patients were assigned to control group as no SMS reminder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Personalized Medication Management Platform for SMS Reminder</intervention_name>
    <description>The Personalized Medication Management Platform was developed by investigators that integrated with Hospital Information System (HIS) to collect the prescription information of patients and automatically send SMS to remind</description>
    <arm_group_label>SMS Medication Reminder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Delayed or forgot to take medications over the last 3 days&#xD;
&#xD;
          -  Received a min. 7-day medication prescription&#xD;
&#xD;
          -  Able to receive SMS using mobile phones / devices&#xD;
&#xD;
          -  20 years or older&#xD;
&#xD;
          -  Having intention to receive active treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to receive SMS via mobile phones&#xD;
&#xD;
          -  Illiterate and &lt; 20 years of age&#xD;
&#xD;
          -  Received outpatient prescription drugs for ≤ 7 days&#xD;
&#xD;
          -  External use, injections and traditional Chinese medicine&#xD;
&#xD;
          -  Planned to go abroad&#xD;
&#xD;
          -  Cold, cough, or prescribed with analgesics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Chuan Li, MD., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University</affiliation>
  </overall_official>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Personalized Medication Management</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>SMS Medication Reminder</keyword>
  <!-- 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/NCT02197689
org study id: NSC 99-2218-E-038-001
nct id: NCT02197689
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Taiwan has attracted much attention for its National Health Insurance (NHI) and healthcare
      system around the world with many countries in Europe and the United States using it as a
      benchmark. However, increasing medication costs over the past two years account for more than
      25% of total expenditure, surpassing every OECD member and mounting increasing pressure on
      the NHI. Nevertheless, patient medication adherence is relatively low. Thus, the
      investigators assessed the effectiveness of a personalized medication management system for
      improving the medication adherence for patients, in order to save long term medication costs.
Design, Setting and Patients: The investigators developed a mobile personalized medication
      management platform (PMMP) to reduce delayed and missed medications. The investigators
      conducted a randomized control trial in medical centers of northern Taiwan from January 2010
      to July 2012 using 1198 participants that missed or delayed their medications during past
      three days. They received a minimum 7-day to 14-day maximum medication prescription.

      Interventions: Patients were randomized into a control group which non-received any SMS
      reminder for medication using and an intervention group which received a SMS reminder
      everyday in mobile devices.

      Primary Outcome(s) and Measure(s): The primary outcomes were compared patient medication
      adherence among experimental and control groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: The proportion of patients in delaying and forgetting medications
time frame: Patients who participated in this trial will be sent SMS during 7days
arm group label: SMS Medication Reminder
arm group type: Experimental
description: 763 patients were assigned to experimental group
arm group label: No SMS Reminder
arm group type: No Intervention
description: 435 patients were assigned to control group as no SMS reminder
intervention type: Device
intervention name: Personalized Medication Management Platform for SMS Reminder
description: The Personalized Medication Management Platform was developed by investigators that integrated with Hospital Information System (HIS) to collect the prescription information of patients and automatically send SMS to remind
arm group label: SMS Medication Reminder
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yu-Chuan Li, MD., PhD
role: Principal Investigator
affiliation: Taipei Medical University
responsible party type: Sponsor