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)

Renal Insufficiency, Chronic Clinical Trial

— AWARE-CKD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498156
• Other study ID #: 21225
• Status: Completed
• Start date: September 16, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• No intervention
No intervention, observational study

Locations

Country	Name	City	State
Canada	Many Facilities	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	LMC Diabetes & Endocrinology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Awareness of chronic kidney disease in T2D	Awareness will be summarized descriptively based on various survey questions.	1 day
Primary	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
Primary	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	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
Secondary	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
Secondary	Time point of communicated CKD diagnosis		1 day