<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/NCT04498156</url>
  </required_header>
  <id_info>
    <org_study_id>21225</org_study_id>
    <nct_id>NCT04498156</nct_id>
  </id_info>
  <brief_title>Survey of Patient and Physician Awareness and Values to the Diagnosis and Treatment of Reduced Kidney Function (Chronic Kidney Disease) in Patients With High Blood Sugar Level (Type 2 Diabetes) (AWARE-CKD in T2D)</brief_title>
  <acronym>AWARE-CKD</acronym>
  <official_title>Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LMC Diabetes &amp; Endocrinology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this survey study, researchers want to find out more about how physicians are treating&#xD;
      patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood&#xD;
      sugar level (type 2 diabetes); what physicians know about the different treatment options&#xD;
      available; and how they use this knowledge to treat their patients successfully.&#xD;
      Additionally, researchers want to gather information about patient's awareness of their&#xD;
      disease and which criteria they consider important for their treatment of the disease.&#xD;
&#xD;
      The study will survey a total of 150 patients with type 2 diabetes: 50 patients with mild&#xD;
      CKD; 50 patients with moderate CKD; and 50 patients with severe CKD. Patients eligible for&#xD;
      this study can be male or female and should be at least 18 years old. In addition, a total of&#xD;
      150 physicians will be surveyed. Physicians eligible for this study may be general&#xD;
      practitioners, endocrinologist, or nephrologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective in this study is to assess the awareness, values and preferences of&#xD;
      patients and physicians with respect to the risks, consequences and management of chronic&#xD;
      kidney disease (CKD) in patients with type 2 diabetes.&#xD;
&#xD;
      Secondary objectives aim to assess awareness of available CKD treatments, referral tools and&#xD;
      communication between patients and physicians.&#xD;
&#xD;
      Both patients and physicians will complete a survey that consists of various questions&#xD;
      regarding the knowledge of disease, values and treatments, patient-physician interaction,&#xD;
      physician referral tools and disease risk management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Awareness of chronic kidney disease in T2D</measure>
    <time_frame>1 day</time_frame>
    <description>Awareness will be summarized descriptively based on various survey questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Values regarding chronic kidney disease in T2D</measure>
    <time_frame>1 day</time_frame>
    <description>Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preferences regarding chronic kidney disease in T2D</measure>
    <time_frame>1 day</time_frame>
    <description>Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Awareness of available treatments for chronic kidney disease in T2D</measure>
    <time_frame>1 day</time_frame>
    <description>Awareness of available treatments will be summarized descriptively based on various survey questions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician awareness of available referral tools for the management of chronic kidney disease in T2D</measure>
    <time_frame>1 day</time_frame>
    <description>Physician cohort only. Referral tools may comprise of various standard guidelines (e.g. KidneyWise, KDIGO guidelines, Diabetes Canada guidelines). A higher number of referral tools known by physicians indicates a better awareness of CKD referral tools.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time point of communicated CKD diagnosis</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <arm_group>
    <arm_group_label>CKD-Patients</arm_group_label>
    <description>Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physicians treating CKD</arm_group_label>
    <description>Cohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention, observational study</description>
    <arm_group_label>CKD-Patients</arm_group_label>
    <arm_group_label>Physicians treating CKD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with CKD and T2DM and treating general practitioners, endocrinologists,&#xD;
        nephrologists in Canada&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For patient cohort:&#xD;
&#xD;
               -  Diagnosis of type 2 diabetes&#xD;
&#xD;
               -  eGFR &lt; 60 ml/min per 1.73 m2 (measured within the last year) OR eGFR ≥ 60 ml/min&#xD;
                  per 1.73 m2 and uACR ≥ 2 (measured within the last year)&#xD;
&#xD;
               -  No documented non-diabetic etiology for renal disease&#xD;
&#xD;
          -  For physician cohort:&#xD;
&#xD;
               -  Licensed general practitioner, endocrinologist or nephrologist&#xD;
&#xD;
               -  Currently providing care for patients with chronic kidney disease and type 2&#xD;
                  diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic kidney disease and type 2 diabetes who are physicians&#xD;
&#xD;
          -  Physicians with chronic kidney disease and type 2 diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many Facilities</name>
      <address>
        <city>Multiple Locations</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic kidney disease (CKD)</keyword>
  <keyword>Type 2 Diabetes (T2D)</keyword>
  <keyword>Patient awareness</keyword>
  <keyword>Physician awareness</keyword>
  <keyword>Interaction patient physician</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498156
org study id: 21225
nct id: NCT04498156
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this survey study, researchers want to find out more about how physicians are treating
      patients diagnosed with reduced kidney function (chronic kidney disease, CKD) and high blood
      sugar level (type 2 diabetes); what physicians know about the different treatment options
      available; and how they use this knowledge to treat their patients successfully.
      Additionally, researchers want to gather information about patient's awareness of their
      disease and which criteria they consider important for their treatment of the disease.

      The study will survey a total of 150 patients with type 2 diabetes: 50 patients with mild
      CKD; 50 patients with moderate CKD; and 50 patients with severe CKD. Patients eligible for
      this study can be male or female and should be at least 18 years old. In addition, a total of
      150 physicians will be surveyed. Physicians eligible for this study may be general
      practitioners, endocrinologist, or nephrologists.
The primary objective in this study is to assess the awareness, values and preferences of
      patients and physicians with respect to the risks, consequences and management of chronic
      kidney disease (CKD) in patients with type 2 diabetes.

      Secondary objectives aim to assess awareness of available CKD treatments, referral tools and
      communication between patients and physicians.

      Both patients and physicians will complete a survey that consists of various questions
      regarding the knowledge of disease, values and treatments, patient-physician interaction,
      physician referral tools and disease risk management.
observational model: Cohort
time perspective: Prospective
measure: Awareness of chronic kidney disease in T2D
time frame: 1 day
description: Awareness will be summarized descriptively based on various survey questions.
measure: Values regarding chronic kidney disease in T2D
time frame: 1 day
description: Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
measure: Preferences regarding chronic kidney disease in T2D
time frame: 1 day
description: Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
measure: Awareness of available treatments for chronic kidney disease in T2D
time frame: 1 day
description: Awareness of available treatments will be summarized descriptively based on various survey questions.
measure: Physician awareness of available referral tools for the management of chronic kidney disease in T2D
time frame: 1 day
description: Physician cohort only. Referral tools may comprise of various standard guidelines (e.g. KidneyWise, KDIGO guidelines, Diabetes Canada guidelines). A higher number of referral tools known by physicians indicates a better awareness of CKD referral tools.
measure: Time point of communicated CKD diagnosis
time frame: 1 day
arm group label: CKD-Patients
description: Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD)
arm group label: Physicians treating CKD
description: Cohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes
intervention type: Other
intervention name: No intervention
description: No intervention, observational study
arm group label: CKD-Patients
arm group label: Physicians treating CKD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.