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) (AWARE-CKD)

Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Canada
  • Multiple Locations, Canada
    • Many facilities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with CKD and T2DM and treating general practitioners, endocrinologists, nephrologists in Canada

Description

Inclusion Criteria:

• For patient cohort:

  • Diagnosis of type 2 diabetes
  • eGFR < 60 ml/min per 1.73 m2 (measured within the last year) OR eGFR ≥ 60 ml/min per 1.73 m2 and uACR ≥ 2 (measured within the last year)
  • No documented non-diabetic etiology for renal disease

• For physician cohort:

  • Licensed general practitioner, endocrinologist or nephrologist
  • Currently providing care for patients with chronic kidney disease and type 2 diabetes

Exclusion Criteria:

• Patients with chronic kidney disease and type 2 diabetes who are physicians
• Physicians with chronic kidney disease and type 2 diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CKD-Patients; Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD)	Other: No intervention; No intervention, observational study
Physicians treating CKD; Cohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes	Other: No intervention; No intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness of chronic kidney disease in T2D	Awareness will be summarized descriptively based on various survey questions.	1 day
Values regarding chronic kidney disease in T2D	Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.	1 day
Preferences regarding chronic kidney disease in T2D	Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness of available treatments for chronic kidney disease in T2D	Awareness of available treatments will be summarized descriptively based on various survey questions.	1 day
Physician awareness of available referral tools for the management of chronic kidney disease in T2D	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.	1 day
Time point of communicated CKD diagnosis		1 day

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: LMC Diabetes & Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Chronic kidney disease (CKD); Type 2 Diabetes (T2D); Patient awareness; Physician awareness; Interaction patient physician
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: 21225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No