Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT04988568
Status:
COMPLETED
Last Update Posted:
2022-05-20
First Post:
2021-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experience of Patients Starting Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences of patients starting dialysis.', 'timeFrame': 'One time interview.', 'description': 'Collect information from interviews to understand the experiences of patients starting dialysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ESRD']}, 'descriptionModule': {'briefSummary': 'Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives.', 'detailedDescription': 'Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives, understand what made patient experiences better, and what could further improve their experiences when patients first start dialysis. The investigators will enroll patients within 90 days of starting dialysis, and conduct semi-structured recorded interviews with patients. All patients will provide informed consent. The interviews will be transcribed verbatim.\n\n* The transcripts will be reviewed line by line by qualitative researchers to identify concepts and themes, and will be developed into a coding schema.\n* The preliminary themes will be discussed among the investigators to facilitate consensus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All incident in-center hemodialysis patients meeting eligibility criteria at Satellite Healthcare, Inc., at IRB approved dialysis centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving in-center hemodialysis care at Satellite Healthcare at the start of the study period.\n* Patients who started with in-center hemodialysis as a first renal replacement therapy.\n* Patients receiving dialysis for ≤ 90 days.\n\nExclusion Criteria:\n\n* Age \\< 18 years.\n* Unable to understand or communicate in English.\n* Inability to participate because of cognitive impairment or active psychological condition.'}, 'identificationModule': {'nctId': 'NCT04988568', 'briefTitle': 'Experience of Patients Starting Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'Experience of Patients Starting Hemodialysis: A Qualitative Study', 'orgStudyIdInfo': {'id': 'SIH130'}}, 'armsInterventionsModule': {'interventions': [{'name': 'None. This is a qualitative interview study.', 'type': 'OTHER', 'description': 'There is no intervention in this study. This is a qualitative research study where patients will be interviewed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare Los Gatos', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare Menlo Park', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '95035', 'city': 'Milpitas', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Heathcare Milpitas', 'geoPoint': {'lat': 37.42827, 'lon': -121.90662}}, {'zip': '95037', 'city': 'Morgan Hill', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis Morgan Hill', 'geoPoint': {'lat': 37.1305, 'lon': -121.65439}}, {'zip': '95037', 'city': 'Morgan Hill', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Health Morgan Hill', 'geoPoint': {'lat': 37.1305, 'lon': -121.65439}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare Mountain View', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94070', 'city': 'San Carlos', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare San Carlos', 'geoPoint': {'lat': 37.50716, 'lon': -122.26052}}, {'zip': '95116', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare East San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95118', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Health Blossom Valley', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95119', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Health San Teresa', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95121', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare SIlver Creek', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95123', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Health South San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '95148', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare Evergreen', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94577', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Healthcare West San Leandro', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94403', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Dialysis San Mateo', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}], 'overallOfficials': [{'name': 'Wael F Hussein, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satellite Healthcare, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual person data will be available to anyone other than Satellite Healthcare Research employees.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}