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/NCT06023615</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00127666</org_study_id>
      <secondary_id>1R01DK134326-01A1</secondary_id>
      <nct_id>NCT06023615</nct_id>
    </id_info>
    <brief_title>MITIGAAT: Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants</brief_title>
    <official_title>Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized study to test a smartphone app that a pharmacist will use to help kidney&#xD;
        transplant patients track their medications, blood pressures, and blood sugars in those with&#xD;
        diabetes. The goal of this study is to improve care and outcomes in kidney transplant&#xD;
        patients and, in particular, help African American patients have better outcomes after&#xD;
        transplant.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overarching hypothesis for MITIGAAT is that late non-adherence and suboptimal control of&#xD;
        diabetes and hypertension are more common in African American kidney recipients and are major&#xD;
        contributors to health disparities. A multimodal intervention that addresses these issues&#xD;
        will significantly reduce disparities. This hypothesis will be tested through a rigorously&#xD;
        conducted, prospective, 2-year randomized controlled trial in 190 kidney transplant&#xD;
        recipients from MUSC, designed to assess the following aims:&#xD;
  &#xD;
        Aim 1. Determine the impact of this multilevel health services intervention on achieving&#xD;
        improved adherence to tacrolimus, measured using tacrolimus trough variability and time in&#xD;
        range in the treatment vs control arm.&#xD;
  &#xD;
        Aim 2. Determine the impact of this multilevel health services intervention on blood pressure&#xD;
        (BP) and glucose control (in those with DM) in the treatment vs control arm.&#xD;
  &#xD;
        Aim 3. Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED&#xD;
        visit costs in the intervention arm vs the control arm and compare this to the costs needed&#xD;
        to deliver the intervention.&#xD;
  &#xD;
        Aim 4. Compare the incidence of acute rejection, graft loss and death in the intervention&#xD;
        patients vs. a large contemporary national cohort of Veteran kidney transplant recipients&#xD;
        while also assessing racial disparities for these health outcomes&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2027</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Medication Adherence</measure>
      <time_frame>2 Years</time_frame>
      <description>Medication adherence will be measured by using tacrolimus trough concentration variability, which is a validated proxy measure of medication adherence. This is defined as the intrapatient tacrolimus concentration coefficient of variation (CV): standard deviation divided by the mean for each patient. All outpatient true trough tacrolimus levels drawn will be used to calculate the tacrolimus CV. This will be assessed every 3 months, which aligns with the minimum lab draw schedule for kidney transplant recipients at out center. This will be analyzed using repeated measures methodology, estimating efficacy effect size using the time*treatment interaction term and disparity using the time*treatment*race interaction term.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood Pressure</measure>
      <time_frame>2 Years</time_frame>
      <description>Blood pressure control will be defined as the mean of all systolic BPs checked by patients at home and the transplant center (ambulatory measures). Patients with a mean of SBP ≤140 mmHg will be considered controlled. We will aggregate and assess blood pressure levels every month (25 total); analyzed using repeated measures (time*treatment and disparity using the time*treatment*race interaction term).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose Control</measure>
      <time_frame>2 Years</time_frame>
      <description>Glucose control is defined as the mean measure of all glucoses (random or fasting). Those with DM and a mean random glucose ≤160 mg/dL will be considered to controlled. We will aggregate and assess glucose levels every month (25 total); analyzed using repeated measures (time*treatment and disparity using the time*treatment*race interaction term).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cost-Benefit Analysis</measure>
      <time_frame>2 Years</time_frame>
      <description>Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED visit costs in the intervention arm vs the control arm and compare this to the costs needed to deliver the intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Rejection</measure>
      <time_frame>2 Years</time_frame>
      <description>This is defined as the proportion of patients in each arm with a renal allograft biopsy showing at least grade 1A rejection by Banff criteria. Per usual care practices, all patients are required to have biopsy confirmation of rejection episodes within 24 hours of onset of treatment for acute rejection. It is standard care that all kidney allograft biopsies performed for transplant recipients occur at the transplant center (study institution). Biopsies will be read by a blinded local pathologist, as usual care. This will be assessed using time to event analyses..</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Graft Failure</measure>
      <time_frame>2 Years</time_frame>
      <description>This is defined as the proportion of patients in each arm with graft failure, which is a composite outcome of either return to chronic dialysis, nephrectomy, re-transplant, or death. The timing and cause of each graft loss will be recorded for comparative analysis.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">190</enrollment>
    <condition>Medication Adherence</condition>
    <condition>Medication Compliance</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Usual Care + mHealth/Telehealth</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual Care + Attention Control</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>mHealth app/dashboard</intervention_name>
      <description>In the interventional group, the subject would receive the standard care that is provided to all post-transplant kidney recipients plus an additional remote monitoring system and follow-up by utilizing an app known as the mHealth app/dashboard. This app is integrated with home-based monitoring of blood pressures, glucoses, and pharmacist-led scheduled televisits.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years of age&#xD;
  &#xD;
            -  ≥2 years post-kidney transplant&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-kidney transplant recipient (liver, lung, heart, intestine, pancreas, bone marrow)&#xD;
  &#xD;
            -  Not capable of measuring own BP and glucose in those with diabetes&#xD;
  &#xD;
            -  Not capable of using mobile health application after adequate training&#xD;
  &#xD;
            -  Not capable of speaking, hearing, and reading English&#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>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>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>David J. Taber</investigator_full_name>
      <investigator_title>Professor-Faculty</investigator_title>
    </responsible_party>
    <!-- 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/NCT06023615
  org study id: Pro00127666
  secondary id: 1R01DK134326-01A1
  nct id: NCT06023615
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a randomized study to test a smartphone app that a pharmacist will use to help kidney
        transplant patients track their medications, blood pressures, and blood sugars in those with
        diabetes. The goal of this study is to improve care and outcomes in kidney transplant
        patients and, in particular, help African American patients have better outcomes after
        transplant.
  The overarching hypothesis for MITIGAAT is that late non-adherence and suboptimal control of
        diabetes and hypertension are more common in African American kidney recipients and are major
        contributors to health disparities. A multimodal intervention that addresses these issues
        will significantly reduce disparities. This hypothesis will be tested through a rigorously
        conducted, prospective, 2-year randomized controlled trial in 190 kidney transplant
        recipients from MUSC, designed to assess the following aims:
  
        Aim 1. Determine the impact of this multilevel health services intervention on achieving
        improved adherence to tacrolimus, measured using tacrolimus trough variability and time in
        range in the treatment vs control arm.
  
        Aim 2. Determine the impact of this multilevel health services intervention on blood pressure
        (BP) and glucose control (in those with DM) in the treatment vs control arm.
  
        Aim 3. Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED
        visit costs in the intervention arm vs the control arm and compare this to the costs needed
        to deliver the intervention.
  
        Aim 4. Compare the incidence of acute rejection, graft loss and death in the intervention
        patients vs. a large contemporary national cohort of Veteran kidney transplant recipients
        while also assessing racial disparities for these health outcomes
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Medication Adherence
  time frame: 2 Years
  description: Medication adherence will be measured by using tacrolimus trough concentration variability, which is a validated proxy measure of medication adherence. This is defined as the intrapatient tacrolimus concentration coefficient of variation (CV): standard deviation divided by the mean for each patient. All outpatient true trough tacrolimus levels drawn will be used to calculate the tacrolimus CV. This will be assessed every 3 months, which aligns with the minimum lab draw schedule for kidney transplant recipients at out center. This will be analyzed using repeated measures methodology, estimating efficacy effect size using the time*treatment interaction term and disparity using the time*treatment*race interaction term.
  measure: Blood Pressure
  time frame: 2 Years
  description: Blood pressure control will be defined as the mean of all systolic BPs checked by patients at home and the transplant center (ambulatory measures). Patients with a mean of SBP ≤140 mmHg will be considered controlled. We will aggregate and assess blood pressure levels every month (25 total); analyzed using repeated measures (time*treatment and disparity using the time*treatment*race interaction term).
  measure: Glucose Control
  time frame: 2 Years
  description: Glucose control is defined as the mean measure of all glucoses (random or fasting). Those with DM and a mean random glucose ≤160 mg/dL will be considered to controlled. We will aggregate and assess glucose levels every month (25 total); analyzed using repeated measures (time*treatment and disparity using the time*treatment*race interaction term).
  measure: Cost-Benefit Analysis
  time frame: 2 Years
  description: Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED visit costs in the intervention arm vs the control arm and compare this to the costs needed to deliver the intervention.
  measure: Acute Rejection
  time frame: 2 Years
  description: This is defined as the proportion of patients in each arm with a renal allograft biopsy showing at least grade 1A rejection by Banff criteria. Per usual care practices, all patients are required to have biopsy confirmation of rejection episodes within 24 hours of onset of treatment for acute rejection. It is standard care that all kidney allograft biopsies performed for transplant recipients occur at the transplant center (study institution). Biopsies will be read by a blinded local pathologist, as usual care. This will be assessed using time to event analyses..
  measure: Graft Failure
  time frame: 2 Years
  description: This is defined as the proportion of patients in each arm with graft failure, which is a composite outcome of either return to chronic dialysis, nephrectomy, re-transplant, or death. The timing and cause of each graft loss will be recorded for comparative analysis.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Usual Care + mHealth/Telehealth
  arm group label: Control Group
  arm group type: No Intervention
  description: Usual Care + Attention Control
  intervention type: Other
  intervention name: mHealth app/dashboard
  description: In the interventional group, the subject would receive the standard care that is provided to all post-transplant kidney recipients plus an additional remote monitoring system and follow-up by utilizing an app known as the mHealth app/dashboard. This app is integrated with home-based monitoring of blood pressures, glucoses, and pharmacist-led scheduled televisits.
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: David J. Taber
  investigator title: Professor-Faculty