<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/NCT01709097</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr 2011/471-31/4</org_study_id>
    <nct_id>NCT01709097</nct_id>
  </id_info>
  <brief_title>Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™.</brief_title>
  <acronym>C/A</acronym>
  <official_title>Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Addoz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tele2Sverige AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ&#xD;
      transplant. Patients need to take their prescribed medications and attend their appointments&#xD;
      with the doctor.&#xD;
&#xD;
      Based on previous studies in other European countries, the cost of non-compliance after organ&#xD;
      transplantation in Sweden is &gt;SEK 35 million/year.&#xD;
&#xD;
      Patients who lose their graft both lose quality of life and have decreased expected survival;&#xD;
      moreover, retransplantation may be hampered by new HLA antibodies.&#xD;
&#xD;
      Question:&#xD;
&#xD;
      The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed&#xD;
      medication regimen in renal transplant patients.&#xD;
&#xD;
      Methods and materials:&#xD;
&#xD;
      All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given&#xD;
      information about the study and will then be asked to participate. Participants will be&#xD;
      randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included&#xD;
      patients will be closely monitored for 1 year regarding intake of prescribed medications.&#xD;
&#xD;
      Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each&#xD;
      occasion when the patient takes medications from the dispenser. It has a SIM card and text&#xD;
      messaging capabilities.&#xD;
&#xD;
      Addoz Portal™ is a web-based application that makes it possible to monitor and analyse&#xD;
      medication intake. Each event in the medication dispenser is registered in the portal, which&#xD;
      communicates with the care provider/support person by text message, e-mail or telephone.&#xD;
&#xD;
      Significance of the study:&#xD;
&#xD;
      In the future it may be possible to improve compliance in transplant patients. In particular,&#xD;
      patients will feel secure since they will receive confirmation through the portal that they&#xD;
      are taking their medications safely and accurately.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study objectives:&#xD;
&#xD;
      To investigate whether Med-O-Wheel™ can improve -&#xD;
&#xD;
        1. adherence to medication regimens,&#xD;
&#xD;
        2. adherence to appointments at the outpatient clinic, and&#xD;
&#xD;
        3. treatment outcome in renal transplant patients. Methodology&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Open, prospective, descriptive, randomized study.&#xD;
&#xD;
      Primary research question:&#xD;
&#xD;
      Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant&#xD;
      patients?&#xD;
&#xD;
      Efficacy parameters:&#xD;
&#xD;
      P-Creatinine, concentrations of medication (B-tacrolimus, B-cyclosporine, B-sirolimus,&#xD;
      P/S-mycophenolate, B-TPMT-metabolites) and age(years).&#xD;
&#xD;
      Addoz Portal for Med-O-Wheel™. Study-specific questionnaire to survey patient discomfort&#xD;
      relating to compliance and adherence.&#xD;
&#xD;
      Safety parameters:&#xD;
&#xD;
      Med-O-Wheel™ and Addoz Portal™ is a CE-approved product with a guarantee for continuous&#xD;
      operation. Karolinska University Laboratory is an accredited testing laboratory.&#xD;
&#xD;
      Volunteer population&#xD;
&#xD;
      Subjects:&#xD;
&#xD;
      All patients about to undergo renal transplantation at Karolinska University Hospital.&#xD;
&#xD;
      Number: 80 patients (40 patients with Med-O-Wheel™, 40 patients with out Med-O-Wheel™).&#xD;
&#xD;
      Time frame First patient included: Juni 2011. Last patient included: Juli 2012. Last patient&#xD;
      completed: Juli 2013.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?</measure>
    <time_frame>2013</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Medication Adherence</condition>
  <condition>Compliance</condition>
  <condition>Medication Nonadherence</condition>
  <condition>Communication</condition>
  <condition>Transplant; Failure, Kidney</condition>
  <arm_group>
    <arm_group_label>With Med-O-Wheel™</arm_group_label>
    <description>Kidney Transplant Recipient with Med-O-Wheel™</description>
  </arm_group>
  <arm_group>
    <arm_group_label>With out Med-O-Wheel™</arm_group_label>
    <description>Kidney Transplant Recipient with out Med-O-Wheel™</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney Transplant Recipients in Karolinska University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Subject is eligible for the study if the following apply:&#xD;
&#xD;
          -  Receiving a kidney transplant from a deceased or living donor in Karolinska University&#xD;
             Hospital&#xD;
&#xD;
          -  Capable of understanding the purpose of the study, fully informed and having written&#xD;
             informed consent (signed Informed Consent has been obtained)&#xD;
&#xD;
        No study-specific exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jarmo Henriksson, SC, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>August 30, 2013</last_update_submitted>
  <last_update_submitted_qc>August 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Gunnar Tydén</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Adherence</keyword>
  <keyword>Compliance</keyword>
  <keyword>Kidney Transplant Recipient</keyword>
  <keyword>An electronic drug dispenser</keyword>
  <keyword>The Portal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</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/NCT01709097
org study id: Dnr 2011/471-31/4
nct id: NCT01709097
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Background:

      Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ
      transplant. Patients need to take their prescribed medications and attend their appointments
      with the doctor.

      Based on previous studies in other European countries, the cost of non-compliance after organ
      transplantation in Sweden is >SEK 35 million/year.

      Patients who lose their graft both lose quality of life and have decreased expected survival;
      moreover, retransplantation may be hampered by new HLA antibodies.

      Question:

      The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed
      medication regimen in renal transplant patients.

      Methods and materials:

      All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given
      information about the study and will then be asked to participate. Participants will be
      randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included
      patients will be closely monitored for 1 year regarding intake of prescribed medications.

      Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each
      occasion when the patient takes medications from the dispenser. It has a SIM card and text
      messaging capabilities.

      Addoz Portal™ is a web-based application that makes it possible to monitor and analyse
      medication intake. Each event in the medication dispenser is registered in the portal, which
      communicates with the care provider/support person by text message, e-mail or telephone.

      Significance of the study:

      In the future it may be possible to improve compliance in transplant patients. In particular,
      patients will feel secure since they will receive confirmation through the portal that they
      are taking their medications safely and accurately.
Study objectives:

      To investigate whether Med-O-Wheel™ can improve -

        1. adherence to medication regimens,

        2. adherence to appointments at the outpatient clinic, and

        3. treatment outcome in renal transplant patients. Methodology

      Study design:

      Open, prospective, descriptive, randomized study.

      Primary research question:

      Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant
      patients?

      Efficacy parameters:

      P-Creatinine, concentrations of medication (B-tacrolimus, B-cyclosporine, B-sirolimus,
      P/S-mycophenolate, B-TPMT-metabolites) and age(years).

      Addoz Portal for Med-O-Wheel™. Study-specific questionnaire to survey patient discomfort
      relating to compliance and adherence.

      Safety parameters:

      Med-O-Wheel™ and Addoz Portal™ is a CE-approved product with a guarantee for continuous
      operation. Karolinska University Laboratory is an accredited testing laboratory.

      Volunteer population

      Subjects:

      All patients about to undergo renal transplantation at Karolinska University Hospital.

      Number: 80 patients (40 patients with Med-O-Wheel™, 40 patients with out Med-O-Wheel™).

      Time frame First patient included: Juni 2011. Last patient included: Juli 2012. Last patient
      completed: Juli 2013.
observational model: Case-Control
time perspective: Prospective
measure: Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?
time frame: 2013
arm group label: With Med-O-Wheel™
description: Kidney Transplant Recipient with Med-O-Wheel™
arm group label: With out Med-O-Wheel™
description: Kidney Transplant Recipient with out Med-O-Wheel™
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jarmo Henriksson, SC, RN
role: Principal Investigator
affiliation: Karolinska University Hospital
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Gunnar Tydén
investigator title: Professor
mesh term: Renal Insufficiency