Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02440659
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2015-04-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christina.pustulka@arborresearch.org', 'phone': '734-665-4108', 'title': 'Francesca Tentori', 'organization': 'Arbor Research Collaborative for Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Serious and Other \\[Not Including Serious\\] Adverse Events were not anticipated nor monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Hemodialysis (HD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Peritoneal Dialysis (PD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Patient's Quality of Life", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1346', 'groupId': 'OG000'}, {'value': '614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemodialysis (HD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.'}, {'id': 'OG001', 'title': 'Peritoneal Dialysis (PD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.'}], 'classes': [{'title': 'Relying on myself', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Doing what I want in my free time', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Spending time with people I care about', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Doing activities that I am interested in', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Traveling out of town', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Maintaining a normal lifestyle', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Managing my daily schedule', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Keeping up with chores', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Being energetic', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Exercising', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Maintaining my weight', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Drinking as much water as I want', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Eating what I like', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Feeling healthy', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Feeling attractive', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Getting enough sleep', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': '% of patients very much or extremely affected by dialysis', 'unitOfMeasure': '% of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hemodialysis (HD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.'}, {'id': 'FG001', 'title': 'Peritoneal Dialysis (PD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1997'}, {'groupId': 'FG001', 'numSubjects': '949'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1346'}, {'groupId': 'FG001', 'numSubjects': '614'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '651'}, {'groupId': 'FG001', 'numSubjects': '335'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1346', 'groupId': 'BG000'}, {'value': '614', 'groupId': 'BG001'}, {'value': '1960', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hemodialysis (HD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.'}, {'id': 'BG001', 'title': 'Peritoneal Dialysis (PD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '686', 'groupId': 'BG000'}, {'value': '384', 'groupId': 'BG001'}, {'value': '1070', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '649', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '878', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.04', 'spread': '14.44', 'groupId': 'BG000'}, {'value': '59.90', 'spread': '14.92', 'groupId': 'BG001'}, {'value': '62.06', 'spread': '14.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '571', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '853', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '766', 'groupId': 'BG000'}, {'value': '331', 'groupId': 'BG001'}, {'value': '1097', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1346', 'groupId': 'BG000'}, {'value': '614', 'groupId': 'BG001'}, {'value': '1960', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Some baseline characteristics were missing for some participants. 10 participants were missing gender information and 12 participants were missing age information.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2946}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2015-04-09', 'resultsFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-10', 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Quality of Life", 'timeFrame': 'Baseline', 'description': '% of patients very much or extremely affected by dialysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Hemodialysis', 'Peritoneal Dialysis'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis.\n\nAim two is based on preliminary results of Aim one interviews, and in collaboration with the Patient Advisory Panel, the investigators developed a brief questionnaire to be administered to participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS) and Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS). Two separate versions of the questionnaire were created to reflect unique aspects of in-center hemodialysis (HD) and peritoneal dialysis (PD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients currently consented in the Dialysis Outcomes and Practice Patterns Study (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals 18 years of age or older.\n* Currently consented in the Dialysis Outcomes and Practice Patterns Study - (DOPPS) or the Peritoneal Outcomes and Practice Patterns Study (PDOPPS).\n\nExclusion Criteria:\n\n* Individuals under 18 years of age.\n* Individuals unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT02440659', 'acronym': 'EPOCH-RRT', 'briefTitle': 'Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)', 'organization': {'class': 'OTHER', 'fullName': 'Arbor Research Collaborative for Health'}, 'officialTitle': 'Empowering Patients on Choices for Renal Replacement Therapy (Aim 2)', 'orgStudyIdInfo': {'id': '1109201303132'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodialysis (HD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.'}, {'label': 'Peritoneal Dialysis (PD)', 'description': 'Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Arbor Research Collaborative for Health', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Francesca Tentori, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arbor Research Collaborative for Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbor Research Collaborative for Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Henry Ford Health System', 'class': 'OTHER'}, {'name': 'National Kidney Foundation, United States', 'class': 'OTHER'}, {'name': 'American Association of Kidney Patients', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}