Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-29 @ 6:09 PM
Study NCT ID:
NCT04498156
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2020-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Awareness of chronic kidney disease in T2D', 'timeFrame': '1 day', 'description': 'Awareness will be summarized descriptively based on various survey questions.'}, {'measure': 'Values regarding chronic kidney disease in T2D', 'timeFrame': '1 day', 'description': 'Values regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.'}, {'measure': 'Preferences regarding chronic kidney disease in T2D', 'timeFrame': '1 day', 'description': 'Preferences regarding risks, consequences and management of chronic kidney disease will be summarized descriptively based on various survey questions.'}], 'secondaryOutcomes': [{'measure': 'Awareness of available treatments for chronic kidney disease in T2D', 'timeFrame': '1 day', 'description': 'Awareness of available treatments will be summarized descriptively based on various survey questions.'}, {'measure': 'Physician awareness of available referral tools for the management of chronic kidney disease in T2D', 'timeFrame': '1 day', 'description': '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.'}, {'measure': 'Time point of communicated CKD diagnosis', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease (CKD)', 'Type 2 Diabetes (T2D)', 'Patient awareness', 'Physician awareness', 'Interaction patient physician'], 'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.", 'detailedDescription': '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.\n\nSecondary objectives aim to assess awareness of available CKD treatments, referral tools and communication between patients and physicians.\n\nBoth 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CKD and T2DM and treating general practitioners, endocrinologists, nephrologists in Canada', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For patient cohort:\n\n * Diagnosis of type 2 diabetes\n * 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)\n * No documented non-diabetic etiology for renal disease\n* For physician cohort:\n\n * Licensed general practitioner, endocrinologist or nephrologist\n * Currently providing care for patients with chronic kidney disease and type 2 diabetes\n\nExclusion Criteria:\n\n* Patients with chronic kidney disease and type 2 diabetes who are physicians\n* Physicians with chronic kidney disease and type 2 diabetes'}, 'identificationModule': {'nctId': 'NCT04498156', 'acronym': 'AWARE-CKD', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Awareness of Diagnosis and Treatment of Chronic Kidney Disease in Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '21225'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD-Patients', 'description': 'Cohort consisting of adult patients with a known diagnosis of type 2 diabetes and evidence of chronic kidney disease (CKD)', 'interventionNames': ['Other: No intervention']}, {'label': 'Physicians treating CKD', 'description': 'Cohort consisting of licensed general practitioners, endocrinologists and nephrologists who are currently treating patients with both chronic kidney disease (CKD) and type 2 diabetes', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention, observational study', 'armGroupLabels': ['CKD-Patients', 'Physicians treating CKD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Canada', 'facility': 'Many Facilities'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Availability of this study\'s data will be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'LMC Diabetes & Endocrinology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}