Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT05659004
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2022-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Referrals for CLTI: Qualitative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-26', 'releaseDate': '2024-06-11'}, {'resetDate': '2024-11-20', 'releaseDate': '2024-09-26'}], 'estimatedResultsFirstSubmitDate': '2024-06-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000089802', 'term': 'Chronic Limb-Threatening Ischemia'}], 'ancestors': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007511', 'term': 'Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experiences and perceptions of patients on their journey to diagnosis of CLTI', 'timeFrame': 'To be conducted in 2023', 'description': 'Exploring patient experience'}], 'secondaryOutcomes': [{'measure': 'Potential improvements the process from first symptom to diagnosis of CLTI', 'timeFrame': 'To be conducted in 2023', 'description': 'Identifying targets for improvement work'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Limb Threatening Ischemia']}, 'descriptionModule': {'briefSummary': 'The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are:\n\n* What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment\n* What is important to patients during this process.\n\nParticipants will be interviewed and their words analysed using reflexive thematic analysis.', 'detailedDescription': 'There are delays at every stage of the patient journey from developing chronic limb-threatening ischaemia (CLTI) to treatment, associated with poorer outcomes for patients. There is currently limited national and international guidance on how and when to refer patients with suspected CLTI to specialist vascular surgery services. The use of qualitative interviews will allow us explore perceptions and experiences of patients with CLTI being referred to vascular surgery services, and identify possible ways to improve the process via interviews. This study will provide novel information on patient experience, and together with other work provide a framework for improvement of the referral process for CLTI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with chronic limb-threatening ischaemia in the last year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- CLTI diagnosed in the last year\n\nExclusion Criteria:\n\n* Lacking capacity to consent to interview\n* Potential to be violent\n* Cognitive impairment\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT05659004', 'briefTitle': 'Referrals for CLTI: Qualitative Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Hull'}, 'officialTitle': 'The Experiences of Patients With Chronic Limb-threatening Ischaemia From First Symptom to Vascular Surgery Assessment: a Qualitative Study', 'orgStudyIdInfo': {'id': '321794'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': '1 qualitative interview', 'interventionNames': ['Behavioral: Qualitative interview']}], 'interventions': [{'name': 'Qualitative interview', 'type': 'BEHAVIORAL', 'description': 'No intervention', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambd', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals NHS Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Mid Yorkshire Hospitals NHS Trust', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}], 'overallOfficials': [{'name': 'Ian Chetter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Hull'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan; data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hull', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Royal College of Surgeons of England', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-11', 'type': 'RELEASE'}, {'date': '2024-09-26', 'type': 'RESET'}, {'date': '2024-09-26', 'type': 'RELEASE'}, {'date': '2024-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Hull'}}}}