Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 4:49 PM
Study NCT ID:
NCT04935827
Status:
COMPLETED
Last Update Posted:
2021-06-23
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006760', 'term': 'Hospitalization'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-08', 'size': 197150, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-08T15:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of dialysis modality at the start of dialysis', 'timeFrame': 'Day 1 of dialysis', 'description': 'Whether patient started with home dialysis or in-center dialysis at the start of dialysis'}, {'measure': 'Type of dialysis modality at the end of month 3 of dialysis', 'timeFrame': 'End of month 3 of dialysis', 'description': 'Whether patient was using home dialysis or in-center dialysis at the end of month 3 of dialysis (day 84)'}, {'measure': 'Type of dialysis modality at the end of month 6 of dialysis', 'timeFrame': 'End of month 6 of dialysis', 'description': 'Whether patient was using home dialysis or in-center dialysis at the end of month 6 of dialysis (day 168)'}, {'measure': 'Type of dialysis modality at the end of month 9 of dialysis', 'timeFrame': 'End of month 9 of dialysis', 'description': 'Whether patient was using home dialysis or in-center dialysis at the end of month 9 of dialysis (day 252)'}, {'measure': 'Type of dialysis modality at the end of month 12 of dialysis', 'timeFrame': 'End of month 12 of dialysis', 'description': 'Whether patient was using home dialysis or in-center dialysis at the end of month 12 of dialysis (day 336)'}, {'measure': 'Mortality in the first year', 'timeFrame': '1 year of dialysis', 'description': 'Whether the patient died in the first year of dialysis and the number of days the patient survived\n\n\\- Censored for transplantation, loss to follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dialysis', 'Peritoneal Dialysis', 'Hospitalizations']}, 'descriptionModule': {'briefSummary': 'This study will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults with fee-for-service Medicare coverage initiating dialysis for end-stage kidney disease in the United States from 12/1/2007-11/30/2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Started dialysis in the USA for end-stage kidney disease from 12/1/2007-11/30/2017\n* No transplant or death prior to day 90 of dialysis\n* Medicare Parts A/B as primary payer 30 days prior to starting dialysis\n* Valid Medicare Evidence Form (Form 2728)\n\nExclusion Criteria:\n\n* As above'}, 'identificationModule': {'nctId': 'NCT04935827', 'briefTitle': 'Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital', 'orgStudyIdInfo': {'id': 'HS-18-00530-2'}, 'secondaryIdInfos': [{'id': 'K08DK118213', 'link': 'https://reporter.nih.gov/quickSearch/K08DK118213', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients initiating dialysis for end-stage kidney disease', 'description': 'Patients whose start of dialysis is from 12/1/2007-11/30/2017. We use the following inclusion criteria:\n\n* Adult (\\>= 18 years old)\n* Did not die or have a transplant prior to the 90th day of dialysis\n* Valid medical evidence form\n* Medicare Part A/B as primary payer in the 30 days prior to initiating dialysis\n* Initiating dialysis in the USA', 'interventionNames': ['Other: Season of Year', 'Other: Hospitalized 14 days prior to dialysis']}], 'interventions': [{'name': 'Season of Year', 'type': 'OTHER', 'description': 'We stratify patients into 4 groups based on the season of the year (between 12/1/2007-11/30/2017)\n\n* Winter: December, January, February\n* Spring: March, April, May\n* Summer: June, July, August\n* Fall: September, October, November', 'armGroupLabels': ['Patients initiating dialysis for end-stage kidney disease']}, {'name': 'Hospitalized 14 days prior to dialysis', 'type': 'OTHER', 'description': 'We further stratify patients into 3 groups based on whether they were hospitalized within 14 days prior to dialysis\n\n* Group 1: No hospitalization prior to dialysis\n* Group 2: Hospitalized within 14 days prior to dialysis for an acute infectious respiratory condition or one of the following acute cardiac conditions (arrhythmia, myocardial infarction, stroke, or fluid overload)\n* Group 3: Hospitalized within 14 days prior to dialysis for a condition not in Group 2', 'armGroupLabels': ['Patients initiating dialysis for end-stage kidney disease']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data are protected by a DUA from the United States Renal Data System. Researchers interested in obtaining the data must obtain a DUA. We will share programs to generate the analyses via an open source sharing resource.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Eugene Lin', 'investigatorAffiliation': 'University of Southern California'}}}}