<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/NCT03753568</url>
  </required_header>
  <id_info>
    <org_study_id>002</org_study_id>
    <nct_id>NCT03753568</nct_id>
  </id_info>
  <brief_title>Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence</brief_title>
  <official_title>Effect of an Electronic Reminder System on Direct Oral Anticoagulant and Oral Diabetes Medication Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helsinki University Central Hospital</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>
      In this study, the effect of an electronic device attached to a push through pill package and&#xD;
      a smart phone application on chronic disease medication adherence is studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study study two different groups of medicine users are recruited. Both groups have 50&#xD;
      patients each. In the first study the participants are using oral medication for diabetes and&#xD;
      in the second study the participants use new direct oral anticoagulants.&#xD;
&#xD;
      Participants use medicine reminder system consisting of an electronic device and an smart&#xD;
      phone application. In the beginning of the study the reminder system is collecting data on&#xD;
      how the patients are taking their medication for the first two months. Smart phone&#xD;
      application is not providing any reminders and participants can't access the app to see the&#xD;
      details.&#xD;
&#xD;
      After two months the application will be unlocked so that it starts reminding the users to&#xD;
      take their medication at the right time. in this phase the patients can view their medication&#xD;
      data from the application. The reminder phase of the study lasts for two months. After these&#xD;
      two plus two months, the results are analyzed and published.&#xD;
&#xD;
      The study continues after these four months for the next four months and after that, the long&#xD;
      term results are analyzed.'&#xD;
&#xD;
      The primary outcome is the possible change in the adherence between control and active&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects are monitored first before the intervention and then during the intervention.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to the medication</measure>
    <time_frame>8 months</time_frame>
    <description>PDC - proportion of days covered</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Variation of daily pill taking times</measure>
    <time_frame>8 months</time_frame>
    <description>The mean difference from the mean pill taking time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anticoagulant Drugs</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants use either direct oral anticoagulants or oral diabetic medication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electronic medicine reminder system</intervention_name>
    <description>Electronic surveillance device is attached to the participants push through pill sheet and the smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  use of direct oral anticoagulants or oral diabetic drugs&#xD;
&#xD;
          -  age of 18 or more&#xD;
&#xD;
          -  subjects have been using a smart phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who don't use their medication without help&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leo Niskanen, M.D. Ph.D</last_name>
      <phone>+358500675727</phone>
      <email>leo.niskanen@fimnet.fi</email>
    </contact>
    <contact_backup>
      <last_name>Janne Sahlman, M.D. Ph.D</last_name>
      <phone>+358405586611</phone>
      <email>janne.m.sahlman@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Helsinki University Central Hospital</investigator_affiliation>
    <investigator_full_name>Janne Sahlman</investigator_full_name>
    <investigator_title>Chief medical officer, Popit Ltd</investigator_title>
  </responsible_party>
  <keyword>medicine reminder</keyword>
  <keyword>diabetes mellitus, type 2</keyword>
  <keyword>direct oral anticoagulants</keyword>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03753568
org study id: 002
nct id: NCT03753568
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the effect of an electronic device attached to a push through pill package and
      a smart phone application on chronic disease medication adherence is studied.
In this study study two different groups of medicine users are recruited. Both groups have 50
      patients each. In the first study the participants are using oral medication for diabetes and
      in the second study the participants use new direct oral anticoagulants.

      Participants use medicine reminder system consisting of an electronic device and an smart
      phone application. In the beginning of the study the reminder system is collecting data on
      how the patients are taking their medication for the first two months. Smart phone
      application is not providing any reminders and participants can't access the app to see the
      details.

      After two months the application will be unlocked so that it starts reminding the users to
      take their medication at the right time. in this phase the patients can view their medication
      data from the application. The reminder phase of the study lasts for two months. After these
      two plus two months, the results are analyzed and published.

      The study continues after these four months for the next four months and after that, the long
      term results are analyzed.'

      The primary outcome is the possible change in the adherence between control and active
      period.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects are monitored first before the intervention and then during the intervention.
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence to the medication
time frame: 8 months
description: PDC - proportion of days covered
measure: Variation of daily pill taking times
time frame: 8 months
description: The mean difference from the mean pill taking time
arm group label: Study group
arm group type: Experimental
description: The participants use either direct oral anticoagulants or oral diabetic medication.
intervention type: Device
intervention name: Electronic medicine reminder system
description: Electronic surveillance device is attached to the participants push through pill sheet and the smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Helsinki University Central Hospital
investigator full name: Janne Sahlman
investigator title: Chief medical officer, Popit Ltd
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided