Clinical trial NCT04498156: 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)
Official title: Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency, Chronic
Keywords: Chronic kidney disease (CKD)
Type 2 Diabetes (T2D)
Patient awareness
Physician awareness
Interaction patient physician
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: LMC Diabetes & Endocrinology
First posted: 2020-08-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD and T2DM and treating general practitioners, endocrinologists, nephrologists in Canada

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Awareness of chronic kidney disease in T2D
timeFrame: 1 day
measure: Values regarding chronic kidney disease in T2D
timeFrame: 1 day
measure: Preferences regarding chronic kidney disease in T2D
timeFrame: 1 day
Secondary outcomes:
measure: Awareness of available treatments for chronic kidney disease in T2D
timeFrame: 1 day
measure: Physician awareness of available referral tools for the management of chronic kidney disease in T2D
timeFrame: 1 day
measure: Time point of communicated CKD diagnosis
timeFrame: 1 day
Other outcomes:
Locations:
city: Multiple Locations
country: Canada
facility: Many Facilities
Study officials:
References: