<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/NCT01671189</url>
  </required_header>
  <id_info>
    <org_study_id>SMMC-MCK-2012</org_study_id>
    <nct_id>NCT01671189</nct_id>
  </id_info>
  <brief_title>Automated SMS-Based Appointment Validation Tool</brief_title>
  <official_title>An Automated SMS-Based Reminder and Rescheduling Tool to Improve Appointment Adherence Rates and Glycemic Control Among Diabetes Patients in San Mateo County</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medic Mobile</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Mateo Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medic Mobile</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation&#xD;
      tool to automate appointment confirmation and rescheduling. Working in parallel with the San&#xD;
      Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will&#xD;
      automate reminders that request text responses from patients to either confirm or request to&#xD;
      reschedule their upcoming appointments. While simple in concept, this tool aims to free up&#xD;
      scarce clinical resources which are currently allocated to daily patient phone call&#xD;
      reminders. With funding from a Bay Area foundation, the investigators will develop and pilot&#xD;
      this open-source software tool in a 12-month randomized-controlled trial, slated to begin in&#xD;
      October 2012. The endpoints of the study will aim to demonstrate improvements in both&#xD;
      appointment adherence and glycemic control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">October 2013</primary_completion_date>
  <phase>Early Phase 1</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic Control (hemoglobin A1c)</measure>
    <time_frame>6-9 months post-enrollment</time_frame>
    <description>The hemoglobin A1c (HbA1c) levels of study participants will be measured at the time of enrollment and at the end of the 6-9 month follow-up period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Appointment Adherence Rate</measure>
    <time_frame>6-9 month post-enrollment</time_frame>
    <description>Appointments scheduled during the 6-9 month follow-up period will be systematically tracked and monitored. The proportion of fulfilled appointments will be compared between the intervention and control arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Diabetes Mellitus Type 2</condition>
  <condition>Adult-onset Diabetes</condition>
  <arm_group>
    <arm_group_label>SMS Appointment Reminders</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Existing Reminder Protocol</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>150 patients will be randomly assigned to the control arm of the study and will not receive SMS reminders about their upcoming appointments. They will, however, be subject to the clinics' existing reminder protocol (phone call reminders by either clinic personnel or computer machine).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS Reminder Software Tool</intervention_name>
    <description>The 150 patients in the intervention arm of the study will receive SMS reminders regarding their upcoming appointments. Working in parallel with the SMMC electronic medical records system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. This bidirectional text messaging system would not interfere with the clinics' existing reminder protocol.</description>
    <arm_group_label>SMS Appointment Reminders</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Belong to Willow Clinic or Fair Oaks Clinic under the San Mateo Medical Center&#xD;
&#xD;
          -  Have a diagnosis of type 2 diabetes as indicated by ICD-9 code of 249.xx or 250.xx&#xD;
&#xD;
          -  Have a most recent hemoglobin A1c (HbA1c) level greater than 7%&#xD;
&#xD;
          -  Are at least 18 years of age&#xD;
&#xD;
          -  Have access to cell phone&#xD;
&#xD;
          -  Are literate or live with a friend/family member who is literate and willing to handle&#xD;
             associated text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a terminal illness and prognosis of less than one year&#xD;
&#xD;
          -  Are unable to demonstrate the ability to reply to an SMS and lack an appropriate proxy&#xD;
&#xD;
          -  Are pregnant or expect to be pregnant in the next 6-9 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadim Mahmud</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medic Mobile</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jessica Qu</last_name>
    <phone>415-728-2208</phone>
    <email>jessica@medicmobile.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mainul Islam</last_name>
    <phone>415-328-7657</phone>
    <email>mainul@medicmobile.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>San Mateo Medical Center</name>
      <address>
        <city>San Mateo</city>
        <state>California</state>
        <zip>94403</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Mike Aratow, Dr.</last_name>
      <email>MAratow@smcgov.org</email>
    </contact>
    <contact_backup>
      <last_name>Jeanette Aviles, Dr.</last_name>
      <email>javiles@smcgov.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.medicmobile.org</url>
    <description>Medic Mobile</description>
  </link>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 22, 2012</last_update_submitted>
  <last_update_submitted_qc>August 22, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01671189
org study id: SMMC-MCK-2012
nct id: NCT01671189
lead sponsor: 
collaborator: 
has dmc: No
Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation
      tool to automate appointment confirmation and rescheduling. Working in parallel with the San
      Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will
      automate reminders that request text responses from patients to either confirm or request to
      reschedule their upcoming appointments. While simple in concept, this tool aims to free up
      scarce clinical resources which are currently allocated to daily patient phone call
      reminders. With funding from a Bay Area foundation, the investigators will develop and pilot
      this open-source software tool in a 12-month randomized-controlled trial, slated to begin in
      October 2012. The endpoints of the study will aim to demonstrate improvements in both
      appointment adherence and glycemic control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Glycemic Control (hemoglobin A1c)
time frame: 6-9 months post-enrollment
description: The hemoglobin A1c (HbA1c) levels of study participants will be measured at the time of enrollment and at the end of the 6-9 month follow-up period.
measure: Appointment Adherence Rate
time frame: 6-9 month post-enrollment
description: Appointments scheduled during the 6-9 month follow-up period will be systematically tracked and monitored. The proportion of fulfilled appointments will be compared between the intervention and control arms.
arm group label: SMS Appointment Reminders
arm group type: Experimental
description: 150 patients will be randomly assigned to the intervention arm of the study and receive text reminders about their upcoming appointments.
arm group label: Existing Reminder Protocol
arm group type: No Intervention
description: 150 patients will be randomly assigned to the control arm of the study and will not receive SMS reminders about their upcoming appointments. They will, however, be subject to the clinics' existing reminder protocol (phone call reminders by either clinic personnel or computer machine).
intervention type: Other
intervention name: SMS Reminder Software Tool
description: The 150 patients in the intervention arm of the study will receive SMS reminders regarding their upcoming appointments. Working in parallel with the SMMC electronic medical records system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. This bidirectional text messaging system would not interfere with the clinics' existing reminder protocol.
arm group label: SMS Appointment Reminders
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nadim Mahmud
role: Principal Investigator
affiliation: Medic Mobile
last name: Jessica Qu
phone: 415-728-2208
email: jessica@medicmobile.org
last name: Mainul Islam
phone: 415-328-7657
email: mainul@medicmobile.org
facility: 
contact: 
contact backup: 
country: United States
url: http://www.medicmobile.org
description: Medic Mobile
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2