Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT02917694
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2016-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WHODAS 2.0 completion rate', 'timeFrame': '2 days', 'description': 'Number of questionnaires completed/returned on admission to ICU'}], 'secondaryOutcomes': [{'measure': 'Time to questionnaire completion rate', 'timeFrame': '2 days', 'description': 'The time taken (hours) from ICU admission to complete the questionnaire'}, {'measure': 'WHODAS 2.0 completion rate', 'timeFrame': '6 months post ICU discharge', 'description': 'Number of questionnaires completed/returned at 6 months post ICU discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Trauma']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.', 'detailedDescription': 'Currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked.\n\nThere is also a need to be able to measure what happens to patients after they leave ICU, and compare their abilities to preadmission status.\n\nThis feasibility study will aim to investigate:\n\n* the time taken to train the physiotherapy team in the use of the outcome measure\n* the ability to obtain pre admission functional status from patients/friend/relative on admission to ICU\n* the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to ICU after multiple trauma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study\n* Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)\n* Male or Female, aged 18 years or above\n* Injury Severity Score greater than 9\n* Admitted as an emergency to AICU\n* Experienced at least 24 hours level three care during their admission\n\nExclusion Criteria:\n\n* Non UK resident (due to potential loss to follow up)\n* Unwilling to consent\n* No GP details available\n* Patients with a palliative diagnosis or established on a palliative treatment pathway'}, 'identificationModule': {'nctId': 'NCT02917694', 'briefTitle': 'A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes of Major Trauma Patients Admitted to an Intensive Care Unit, Using the WHO DAS 2.0.', 'orgStudyIdInfo': {'id': '209899'}}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Rebekah Haylett, BSc (Hons)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxfod University Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Rebekah Haylett', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}