- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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) (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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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-
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Multiple Locations, 캐나다
- Many facilities
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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CKD-Patients
Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD)
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개입 없음, 관찰 연구
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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
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개입 없음, 관찰 연구
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Awareness of chronic kidney disease in T2D
기간: 1 day
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Awareness will be summarized descriptively based on various survey questions.
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1 day
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Values regarding chronic kidney disease in T2D
기간: 1 day
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Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
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1 day
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Preferences regarding chronic kidney disease in T2D
기간: 1 day
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Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.
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1 day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Awareness of available treatments for chronic kidney disease in T2D
기간: 1 day
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Awareness of available treatments will be summarized descriptively based on various survey questions.
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1 day
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Physician awareness of available referral tools for the management of chronic kidney disease in T2D
기간: 1 day
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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.
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1 day
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Time point of communicated CKD diagnosis
기간: 1 day
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1 day
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 21225
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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