<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/NCT03247322</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00068746</org_study_id>
    <nct_id>NCT03247322</nct_id>
  </id_info>
  <brief_title>mHealth Medication Safety Intervention</brief_title>
  <official_title>Improving Transplant Medication Safety Through A Pharmacist-Empowered, Patient-Centered, Mhealth-Based Intervention (TRANSAFE Rx Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</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>
      TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial,&#xD;
      involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness&#xD;
      of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve&#xD;
      medication safety and health outcomes, as compared to usual post-transplant care. The primary&#xD;
      goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues&#xD;
      leading to reduced healthcare resource utilization in kidney transplantation through a&#xD;
      pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel&#xD;
      information on the incidence, etiologies and outcomes of med errors and adverse drug events&#xD;
      in this high-risk population; while also demonstrating the effectiveness of this intervention&#xD;
      on reducing the incidence and impact of med safety issues in kidney transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>In order to minimize bias, data for outcomes will be collected by a blinded study coordinator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Medication Errors</measure>
    <time_frame>1 year</time_frame>
    <description>Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence and Severity of Adverse Drug Events</measure>
    <time_frame>1 year</time_frame>
    <description>Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care.&#xD;
Rates of Events Per Patient Year by AE Grade</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of Medication Errors</measure>
    <time_frame>1 year</time_frame>
    <description>Severity of Medication Errors were measured using the Overhage criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalization Rate</measure>
    <time_frame>1 year</time_frame>
    <description>Number of hospitalizations per patient-year</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infection Rate</measure>
    <time_frame>1 year</time_frame>
    <description>Number of infections per patient-year</description>
  </other_outcome>
  <other_outcome>
    <measure>Opportunistic Infection Rate</measure>
    <time_frame>1 year</time_frame>
    <description>Opportunistic infections per patient-year</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Medication Compliance</condition>
  <arm_group>
    <arm_group_label>mHealth Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist-led medication therapy using mHealth application</intervention_name>
    <description>This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
    <arm_group_label>mHealth Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Kidney transplant recipient between 6 and 36 months post-transplant&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Transplant MD agrees that patient is eligible to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multi-organ recipient&#xD;
&#xD;
          -  Patient is incapable of:&#xD;
&#xD;
          -  Measuring their own blood pressure and glucose (if applicable)&#xD;
&#xD;
          -  Self-administering medications&#xD;
&#xD;
          -  Speaking, hearing and reading English&#xD;
&#xD;
          -  Utilizing the mHealth application, after training&#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>David Taber, PharmD,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <results_first_submitted>February 1, 2021</results_first_submitted>
  <results_first_submitted_qc>February 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2021</results_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medication Safety</keyword>
  <keyword>Mobile Health Technology</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 15, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03247322/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>mHealth Group</title>
          <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
        </group>
        <group group_id="P2">
          <title>Usual Care Group</title>
          <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="136"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" spread="12"/>
                    <measurement group_id="B2" value="51" spread="14"/>
                    <measurement group_id="B3" value="51" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants on Dialysis at Transplant</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Medication Errors</title>
        <description>Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Medication Errors</title>
          <description>Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended</description>
          <units>number of medication errors</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="5.4"/>
                    <measurement group_id="O2" value="20" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence and Severity of Adverse Drug Events</title>
        <description>Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care.&#xD;
Rates of Events Per Patient Year by AE Grade</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence and Severity of Adverse Drug Events</title>
          <description>Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care.&#xD;
Rates of Events Per Patient Year by AE Grade</description>
          <units>adverse events per patient year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.68" spread="18.35"/>
                    <measurement group_id="O2" value="21.26" spread="25.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.96" spread="1.47"/>
                    <measurement group_id="O2" value="14" spread="15.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.53" spread="0.72"/>
                    <measurement group_id="O2" value="5.28" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread=".22"/>
                    <measurement group_id="O2" value="1.57" spread=".34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".07" spread=".05"/>
                    <measurement group_id="O2" value="0.38" spread=".15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value=".01" spread=".01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or higher</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread=".25"/>
                    <measurement group_id="O2" value="1.97" spread=".46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Severity of Medication Errors</title>
        <description>Severity of Medication Errors were measured using the Overhage criteria</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mHealth Group</title>
            <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of Medication Errors</title>
          <description>Severity of Medication Errors were measured using the Overhage criteria</description>
          <units>number of medication errors</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Potentially Lethal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586"/>
                    <measurement group_id="O2" value="1320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospitalization Rate</title>
        <description>Number of hospitalizations per patient-year</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mHealth Group</title>
            <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospitalization Rate</title>
          <description>Number of hospitalizations per patient-year</description>
          <units>Hospitalizations per patient-year</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" lower_limit="0.4" upper_limit="0.94"/>
                    <measurement group_id="O2" value="1.08" lower_limit="0.60" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Infection Rate</title>
        <description>Number of infections per patient-year</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mHealth Group</title>
            <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Infection Rate</title>
          <description>Number of infections per patient-year</description>
          <units>Infections per patient-year</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" lower_limit="0.92" upper_limit="1.72"/>
                    <measurement group_id="O2" value="1.26" lower_limit="0.76" upper_limit="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Opportunistic Infection Rate</title>
        <description>Opportunistic infections per patient-year</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>mHealth Group</title>
            <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Group</title>
            <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Opportunistic Infection Rate</title>
          <description>Opportunistic infections per patient-year</description>
          <units>Opportunistic infection per patient-year</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".19" lower_limit=".09" upper_limit="0.30"/>
                    <measurement group_id="O2" value=".14" lower_limit=".01" upper_limit=".30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>The data was analyzed by adverse event type and severity, not specific adverse event terms.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).&#xD;
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GI Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Abnormal Vital Signs</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Laboratory abnormality</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous System Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="68" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="59" subjects_affected="59" subjects_at_risk="68"/>
                <counts group_id="E2" events="63" subjects_affected="63" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Disorders</sub_title>
                <counts group_id="E1" events="30" subjects_affected="30" subjects_at_risk="68"/>
                <counts group_id="E2" events="29" subjects_affected="29" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural complications</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Laboratory Abnormality</sub_title>
                <counts group_id="E1" events="64" subjects_affected="64" subjects_at_risk="68"/>
                <counts group_id="E2" events="64" subjects_affected="64" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>musculoskeletal disorder</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous System Disorder</sub_title>
                <counts group_id="E1" events="23" subjects_affected="23" subjects_at_risk="68"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Disorders</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory disorders</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="68"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>David Taber, PharmD, MS</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>843-792-3368</phone>
      <email>taberd@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03247322
org study id: Pro00068746
nct id: NCT03247322
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
TRANSAFE Rx is a 12-month, parallel two-arm, 1:1 randomized controlled clinical trial,
      involving 136 participants (68 in each arm) measuring the clinical and economic effectiveness
      of a pharmacist-led intervention, which utilizes an innovative mHealth application to improve
      medication safety and health outcomes, as compared to usual post-transplant care. The primary
      goal of the TRANSAFE Rx study is to demonstrate significant reductions in med safety issues
      leading to reduced healthcare resource utilization in kidney transplantation through a
      pharmacist-led, mHealth-enabled, intervention. This study will provide detailed and novel
      information on the incidence, etiologies and outcomes of med errors and adverse drug events
      in this high-risk population; while also demonstrating the effectiveness of this intervention
      on reducing the incidence and impact of med safety issues in kidney transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: In order to minimize bias, data for outcomes will be collected by a blinded study coordinator.
measure: Number of Medication Errors
time frame: 1 year
description: Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended
measure: Incidence and Severity of Adverse Drug Events
time frame: 1 year
description: Adverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care.
Rates of Events Per Patient Year by AE Grade
measure: Severity of Medication Errors
time frame: 1 year
description: Severity of Medication Errors were measured using the Overhage criteria
measure: Hospitalization Rate
time frame: 1 year
description: Number of hospitalizations per patient-year
measure: Infection Rate
time frame: 1 year
description: Number of infections per patient-year
measure: Opportunistic Infection Rate
time frame: 1 year
description: Opportunistic infections per patient-year
arm group label: mHealth Group
arm group type: Experimental
description: Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
arm group label: Usual Care Group
arm group type: No Intervention
description: Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
intervention type: Other
intervention name: Pharmacist-led medication therapy using mHealth application
description: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
arm group label: mHealth Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Taber, PharmD,MS
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 