Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-29 @ 4:06 AM
Study NCT ID:
NCT02878902
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of the Implementation of CKD Coordination Function on Dialysis Initiation Frequency in Emergency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D004630', 'term': 'Emergencies'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of emergency dialysis patients beginner', 'timeFrame': 'Change of this percentage from baseline at 2 years', 'description': 'The outcome is mesured at baseline (implementation of the nurse coordinator of chronic renal failure\n\nthe nurse coordinator of chronic renal failure\n\nBaseline = implementation of this function of coordination of patients with chronic renal failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['emergency', 'coordination', 'dialysis'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Kidney failure is a major public health problem. REIN registry shows that 33% of patients treated in renal replacement therapy for ESRD start dialysis in emergency. Unscheduled care is associated with an increased risk of morbidity and mortality, with less access to off dialysis center and kidney transplant. In addition, the emergency management has an impact on the organization of health structures. The High Authority of Health in 2012 issued a "care pathway Guide" aimed "to report in this process of the multidisciplinary nature of the management and coordination of principles and procedures for the Chronic Renal failure and cooperation between professionals involved. " A function of coordinator of the Chronic Renal Disease was set up in service since May 2013. Investigators propose to carry out a study to value its impact on the start of the dialysis in emergency and hypothesize that this feature innovative in France improves the patient pathway and thus reduce support emergency frequency of ESRD.\n\nThe objective of this study is to show the improvement of the quality of care for terminally chronic renal failure patients.\n\nThis is to evaluate an experiment aimed to facilitate a complex care path. If this experiment is successful, it could form part of "advanced practice".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with chronic kidney disease in our center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years with terminal chronic renal failure enrolled in the course of care\n\nExclusion Criteria:\n\n* Patients under 18 years\n* Patient Off Course\n* Patient beginning dialysis with a method of transition'}, 'identificationModule': {'nctId': 'NCT02878902', 'acronym': 'ICoDU', 'briefTitle': 'Impact of the Implementation of CKD Coordination Function on Dialysis Initiation Frequency in Emergency', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Impact of the Implementation of a Chronic Kidney Disease (CKD) Coordination Function on Dialysis Initiation Frequency in Emergency', 'orgStudyIdInfo': {'id': '15-199'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Before implementation', 'description': 'Patients registered in monitoring French registry of renal patients "Réseau Epidémiologie et Information en Néphrologie" (REIN) from January 1, 2012 to December 31, 2013'}, {'label': 'Post implementation', 'description': 'Patients registered in monitoring French registry of renal patients "Réseau Epidémiologie et Information en Néphrologie" (REIN) from January 1, 2014 to December 31, 2015', 'interventionNames': ['Other: Post implementation']}], 'interventions': [{'name': 'Post implementation', 'type': 'OTHER', 'description': 'Patient group whose care course was organized by the nurse coordinator of chronic renal failure', 'armGroupLabels': ['Post implementation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}