Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT04225416
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2020-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perceptions of Illness Severity, Treatment Goals and Life Expectancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Current practice regarding discussion of prognosis with seriously ill dialysis patients, to better understand the dissonance between physician and patient beliefs on prognosis, transplant candidacy and goals of care.', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Completion of questionnaire or structured interview'}], 'secondaryOutcomes': [{'measure': 'Number of dialysis patients who are more optimistic about prognosis and transplant candidacy than their nephrologists', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Completion of questionnaire or structured interview'}, {'measure': "Patients' prognostic expectations are associated with their treatment preferences", 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Completion of questionnaire or structured interview'}, {'measure': 'Number of patients with dialysis associated symptoms as assessed by IPOS Renal (https://pos-pal.org/maix/ipos-renal-in-english.php).', 'timeFrame': '7 days', 'description': 'Completion of questionnaire or structured interview'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemodialysis', 'peritoneal dialysis'], 'conditions': ['Hemodialysis', 'Peritoneal Dialysis']}, 'descriptionModule': {'briefSummary': 'This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.', 'detailedDescription': "Sharing and communicating information with patients is an integral part of medical care, yet research has shown that disparities exist between physicians and patient perceptions of illness severity. In renal medicine, along with many other specialties, expected prognosis can affect treatment offered.Thus appreciating and understanding one's prognosis can influence patients and relatives' expectations for treatment and guide discussions regarding quality of life.\n\nPrevious work has highlighted disparities in the United States between expectations of survival of seriously ill haemodialysis patients and their physicians. The investigators plan to repeat this study within the United Kingdom, to see whether similar issues occur and to elucidate current practice on discussions of prognosis, symptom burden and transplant candidacy. The investigators hope to identify where care can be improved and to enable patients to better make informed decisions on treatment and goals of care.\n\nPart one of the study is to repeat this study in haemodialysis patients in the United Kingdom. This has been completed and published (2021) at https://www.kireports.org/article/S2468-0249(21)00103-0/fulltext.\n\nPart two of the study is to extend the study to peritoneal dialysis patients in the United Kingdom."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dialysis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Haemodialysis patients 18-100 years old, with a predicted mortality risk of \\>20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.\n* Peritoneal dialysis patients 18-100 years old, with a predicted mortality risk of \\>20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.\n\nExclusion Criteria:\n\n* Patients on home haemodialysis'}, 'identificationModule': {'nctId': 'NCT04225416', 'acronym': 'ePISTLE', 'briefTitle': 'Perceptions of Illness Severity, Treatment Goals and Life Expectancy', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'The ePISTLE Study: Perceptions of Illness Severity, Treatment Goals and Life Expectancy', 'orgStudyIdInfo': {'id': '18HH4336'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodialysis patients', 'description': 'Patients undergoing hemodialysis', 'interventionNames': ['Other: Questionnaire/Structured Interview']}, {'label': 'Peritoneal dialysis patients', 'description': 'Patients undergoing peritoneal dialysis', 'interventionNames': ['Other: Questionnaire/Structured Interview']}], 'interventions': [{'name': 'Questionnaire/Structured Interview', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Hemodialysis patients', 'Peritoneal dialysis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Hannah Beckwith', 'role': 'CONTACT', 'email': 'hannah.beckwith@nhs.net', 'phone': '02033131000'}], 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Hannah Beckwith, MBChB', 'role': 'CONTACT', 'email': 'hannah.beckwith@nhs.net', 'phone': '02033131000'}], 'overallOfficials': [{'name': 'Edwina Brown, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}