check_circleStudy Completed

Renal Insufficiency, Chronic

Bayer Identifier:

21225

ClinicalTrials.gov Identifier:

NCT04498156

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - Patients with chronic kidney disease and type 2 diabetes who are physicians
    - Physicians with chronic kidney disease and type 2 diabetes

Trial summary

Enrollment Goal
300
Trial Dates
September 2020 - April 2021
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Recruiting
Many FacilitiesMany Locations, Canada

Primary Outcome

  • Awareness of chronic kidney disease in T2D
    Awareness will be summarized descriptively based on various survey questions.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    1 day

Secondary Outcome

  • Awareness of available treatments for chronic kidney disease in T2D
    Awareness of available treatments will be summarized descriptively based on various survey questions.
    date_rangeTime Frame:
    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.
    date_rangeTime Frame:
    1 day
  • Time point of communicated CKD diagnosis
    date_rangeTime Frame:
    1 day

Trial design

Awareness of diagnosis and treatment of chronic kidney disease in patients with type 2 diabetes
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A