xml: <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/NCT06004102</url>
    </required_header>
    <id_info>
      <org_study_id>KAEK-315</org_study_id>
      <nct_id>NCT06004102</nct_id>
    </id_info>
    <brief_title>Medication Adherence in Kidney Transplant</brief_title>
    <official_title>Impact of Text Message Reminders on Immunosuppressive Medication Adherence Among Kidney Transplant Recipients: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akdeniz University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akdeniz University 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>
        Aims and Objective: The study aimed to assess the impact of text message reminders on&#xD;
        medication adherence among kidney transplant recipients.&#xD;
  &#xD;
        Background: One of the most common problems encountered in transplant patients is&#xD;
        incompatibility with immunosuppressive drugs, one of the most important reasons for graft&#xD;
        rejection.&#xD;
  &#xD;
        Design: A randomized controlled trial was conducted from January to October 2021 and&#xD;
        conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.&#xD;
  &#xD;
        Methods: This randomized controlled trial included a total of 100 patients receiving a kidney&#xD;
        transplant, 50 in the intervention group and 50 in the control group. Patients in the&#xD;
        intervention group were sent text message reminders four times a day during the 6th to 9th&#xD;
        months after transplantation. Control patients received no such intervention. Tacrolimus&#xD;
        concentrations in the bloodstream were monitored for all participants through measurements&#xD;
        taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive&#xD;
        Characteristics Form and Immunosuppressive Medication Adherence Scale.&#xD;
  &#xD;
        Research hypotheses H1- Sending text message reminders improves immunosuppressive medication&#xD;
        adherence in kidney transplant recipients.&#xD;
  &#xD;
        H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood&#xD;
        profiles in kidney transplant recipients.&#xD;
  &#xD;
        H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence&#xD;
        Scale and mean tacrolimus plasma levels in kidney transplant recipients.&#xD;
  &#xD;
        H4- There is a correlation between the sociodemographic and descriptive characteristics of&#xD;
        kidney transplant recipients and their mean scores from the Immunosuppressive Medication&#xD;
        Adherence Scale.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">February 8, 2023</completion_date>
    <primary_completion_date type="Actual">October 1, 2021</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of sending reminder text messages on immunosuppressive medication adherence</measure>
      <time_frame>baseline and 9 months</time_frame>
      <description>The IMAS is a validated an 11-item self-report questionnaire developed in 2015 to measure medication adherence in patients that have received solid organ transplants and are prescribed immunosuppressive drugs.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">100</enrollment>
    <condition>Medication Adherence</condition>
    <arm_group>
      <arm_group_label>reminder text message</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the intervention groups as a pretest. Short text messages to remind the use of immunosuppressive medication and educational text messages were sent to patients in the intervention group four times a day, every day for three months. The intervention group also received educational text messages three days a week, in addition to such text message reminders.&#xD;
  The text message contents prepared for the intervention group were sent automatically to patients at specified times via the purchased program. At the end of the study, intervention groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>no intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the control groups as a pretest. The control group did not receive any such intervention. At the end of the study, control groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>reminder text message</intervention_name>
      <description>The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.</description>
      <arm_group_label>reminder text message</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  Being a recipient of a kidney transplant for the first time&#xD;
  &#xD;
            -  Being a kidney transplant recipient at post-transplant month 6 with scheduled&#xD;
               follow-up until month 9&#xD;
  &#xD;
            -  Ongoing immunosuppressive drug therapy&#xD;
  &#xD;
            -  Absence of any disability that hinders communication&#xD;
  &#xD;
            -  No diagnosis of psychological and mental problems&#xD;
  &#xD;
            -  Being an active cell phone user&#xD;
  &#xD;
            -  Ability to read and write&#xD;
  &#xD;
            -  Voluntary participation in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hospitalization for any reason during the research period&#xD;
  &#xD;
            -  History of combined or dual organ transplantation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Akdeniz University</name>
        <address>
          <city>Antalya</city>
          <state>Konyaalti</state>
          <zip>07058</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Akdeniz University Hospital</investigator_affiliation>
      <investigator_full_name>Kübra Erdal</investigator_full_name>
      <investigator_title>Nurse</investigator_title>
    </responsible_party>
    <keyword>kidney transplantation</keyword>
    <keyword>reminder text messages</keyword>
    <keyword>medication adherence</keyword>
    <keyword>surgical nursing</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004102
  org study id: KAEK-315
  nct id: NCT06004102
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aims and Objective: The study aimed to assess the impact of text message reminders on
        medication adherence among kidney transplant recipients.
  
        Background: One of the most common problems encountered in transplant patients is
        incompatibility with immunosuppressive drugs, one of the most important reasons for graft
        rejection.
  
        Design: A randomized controlled trial was conducted from January to October 2021 and
        conducted in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines.
  
        Methods: This randomized controlled trial included a total of 100 patients receiving a kidney
        transplant, 50 in the intervention group and 50 in the control group. Patients in the
        intervention group were sent text message reminders four times a day during the 6th to 9th
        months after transplantation. Control patients received no such intervention. Tacrolimus
        concentrations in the bloodstream were monitored for all participants through measurements
        taken at months 7,8, and 9. Data collection tools included Sociodemographic and Descriptive
        Characteristics Form and Immunosuppressive Medication Adherence Scale.
  
        Research hypotheses H1- Sending text message reminders improves immunosuppressive medication
        adherence in kidney transplant recipients.
  
        H2- Utilization of text messages as reminders has a significant influence on tacrolimus blood
        profiles in kidney transplant recipients.
  
        H3- There is a correlation between the scores from the Immunosuppressive Medication Adherence
        Scale and mean tacrolimus plasma levels in kidney transplant recipients.
  
        H4- There is a correlation between the sociodemographic and descriptive characteristics of
        kidney transplant recipients and their mean scores from the Immunosuppressive Medication
        Adherence Scale.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: The effect of sending reminder text messages on immunosuppressive medication adherence
  time frame: baseline and 9 months
  description: The IMAS is a validated an 11-item self-report questionnaire developed in 2015 to measure medication adherence in patients that have received solid organ transplants and are prescribed immunosuppressive drugs.
  arm group label: reminder text message
  arm group type: Experimental
  description: At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the intervention groups as a pretest. Short text messages to remind the use of immunosuppressive medication and educational text messages were sent to patients in the intervention group four times a day, every day for three months. The intervention group also received educational text messages three days a week, in addition to such text message reminders.
  The text message contents prepared for the intervention group were sent automatically to patients at specified times via the purchased program. At the end of the study, intervention groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest.
  arm group label: no intervention
  arm group type: No Intervention
  description: At the baseline of the study, the Sociodemographic and Descriptive Characteristics Form and IMAS were administered to patients in the control groups as a pretest. The control group did not receive any such intervention. At the end of the study, control groups of participants completing the 9-month follow-up were administered the IMAS questionnaire as a posttest.
  intervention type: Other
  intervention name: reminder text message
  description: The study aimed to assess the impact of text message reminders on medication adherence among kidney transplant recipients.
  arm group label: reminder text message
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Akdeniz University Hospital
  investigator full name: Kübra Erdal
  investigator title: Nurse