Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-27 @ 11:16 AM
Study NCT ID:
NCT06819332
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2017-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pedal Cycle Related Trauma at the Royal London Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 644}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiology of bicycle related accidents in London in patients who present to the Royal London Hospital.', 'timeFrame': '14 days', 'description': 'Measure epidemiology of bicycle related accidents in London'}], 'secondaryOutcomes': [{'measure': "To map collision hotspots in London and quantify and draw patients' quality of life after injury using using EQ-5D - EuroQol as a measuring tool to assess patient generic health status and SF-12 to measure functional health and well-being.", 'timeFrame': '6 Weeks (+/-2 weeks)', 'description': 'Using EQ-5D - EuroQol as a measuring tool to assess patient generic health. 5-level EQ-5D version by EuroQol for descriptive and visual analogue scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bicycle Accident']}, 'descriptionModule': {'briefSummary': "Bespoke is an observational, prospective, cohort study. The aim of this study is to explore injury patterns of patients who require admission to the Royal London Hospital (RLH) Emergency Department (ED)or outpatient clinics as a result of any collision involving a bicycle. Secondary objectives are to determine the circumstances around cycling injury and to explore the effect of cycling collisions on the return to work, activities of daily living and cycling. All patients that attend the Emergency Department of the Royal London Hospital following an injury sustained while cycling, will be invited to take part in the study. Participants will be asked to answer a questionnaire about their cycling routines as well as provide information about the location, conditions and events surrounding their collision. Patients' recovery will be followed by the study team using the electronic health record and by reviewing the patients' notes. Morbidity and mortality data will be completed at death, discharge or 28 days from admission (whichever comes first). The patients will be followed up in person, email, or via telephone at 6 weeks following their initial admission. The research team hosted a Patient and Public Involvement (PPI) event, to determine which outcome measures were important for the public to investigate. It was found that the majority of the group felt it was important to follow up return to work, return to cycling and return to activities of daily living in any patients who have had a cycling collision. These outcomes will be measured at the 6 week follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who attend the Royal London HOSPT', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are 16 years and older attending the Royal London Hospital Emergency department who have been injured while riding a bicycle (pedal cycle)\n* All patients who are 16 years and older who are transferred to the Royal London Hospital, either for inpatient or outpatient care, who were injured whilst riding a bicycle\n\nExclusion Criteria:\n\n* Patients who have been injured while involved in activities other than cycling\n* Patients that decline to take part in the study\n* Patients who are 15 years or younger\n* Off road cyclists\n* motorbike riders'}, 'identificationModule': {'nctId': 'NCT06819332', 'briefTitle': 'Pedal Cycle Related Trauma at the Royal London Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'An Observational Study of Pedal Cycle Related Trauma at the Royal London Hospital', 'orgStudyIdInfo': {'id': '158400'}}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}