Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT03405766
Status:
COMPLETED
Last Update Posted:
2018-11-30
First Post:
2017-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-29', 'studyFirstSubmitDate': '2017-12-13', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study recruitment barriers, Medical', 'timeFrame': '2018-2022', 'description': 'Number (%) of patients unable to give consent or to sign'}, {'measure': 'Study recruitment barriers, Ethical', 'timeFrame': '2018-2022', 'description': 'Number (%) of patients not asked to give consent due to ethical issues'}], 'secondaryOutcomes': [{'measure': 'Study recruitment barriers, Practical', 'timeFrame': '2018-2022', 'description': 'Number (%) of cases where practical reasons made consent impossible'}, {'measure': 'Study recruitment barriers, Legal', 'timeFrame': '2018-2022', 'description': 'Number (%) of patients where legal issues made consent impossible'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill', 'Ethics', 'Informed Consent', 'Study Recruitment']}, 'referencesModule': {'references': [{'pmid': '32513204', 'type': 'DERIVED', 'citation': 'Dahlberg J, Eriksen C, Robertsen A, Beitland S. Barriers and challenges in the process of including critically ill patients in clinical studies. Scand J Trauma Resusc Emerg Med. 2020 Jun 8;28(1):51. doi: 10.1186/s13049-020-00732-x.'}]}, 'descriptionModule': {'briefSummary': 'The study will explore barriers in the process of achieving informed consent from critically ill patients', 'detailedDescription': 'The barriers will be divided into four major categories:\n\n* Practical barriers\n* Medical barriers\n* Legal barriers\n* Ethical barriers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care unit patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients considered for inclusion in the NORIDES study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03405766', 'briefTitle': 'Barriers in the Process of Achieving Informed Consent From Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Barriers in the Process of Achieving Informed Consent From Critically Ill Patients', 'orgStudyIdInfo': {'id': 'REK 2017/1254'}}, 'contactsLocationsModule': {'locations': [{'zip': '0540', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not planned to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Akershus', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sigrid Beitland', 'investigatorAffiliation': 'Oslo University Hospital'}}}}