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Completed

NCT Number: 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)

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Facilities

Multiple Locations, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention, observational study

Primary outcomes

  1. Awareness of chronic kidney disease in T2D

    Time frame: 1 day

    Awareness will be summarized descriptively based on various survey questions.

  2. Values regarding chronic kidney disease in T2D

    Time frame: 1 day

    Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.

  3. Preferences regarding chronic kidney disease in T2D

    Time frame: 1 day

    Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.

Secondary outcomes

  1. Awareness of available treatments for chronic kidney disease in T2D

    Time frame: 1 day

    Awareness of available treatments will be summarized descriptively based on various survey questions.

  2. Physician awareness of available referral tools for the management of chronic kidney disease in T2D

    Time frame: 1 day

    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.

  3. Time point of communicated CKD diagnosis

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • LMC Diabetes & Endocrinology

Registry information

Official study title

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

Acronym: AWARE-CKD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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