Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04903756
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2021-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The PERCEIVE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of audio-recorded consultations between surgeons and patients.', 'timeFrame': 'During primary consultation', 'description': 'Theme-oriented discourse analysis'}], 'secondaryOutcomes': [{'measure': 'Analysis of patient interviews', 'timeFrame': 'As soon as possible after the time of consultation and approximately 6 months following consultation', 'description': 'Thematic analysis of interview transcripts'}, {'measure': 'Analysis of healthcare professional interviews', 'timeFrame': 'As soon as possible after the time of consultation', 'description': 'Thematic analysis of interview transcripts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major lower limb amputation', 'Risk perception', 'Shared decision making'], 'conditions': ['Amputation', 'Peripheral Artery Disease', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The PERCEIVE (PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation - a collaboratiVE study) study aims to explore how decisions about major lower limb amputations are made by patients and healthcare professionals.', 'detailedDescription': 'This study will look in detail at major lower limb amputation risk perception, communication and decision-making, both from a patient/family and a surgeon/clinician point of view. The investigators will audio-record 10-15 consultations between surgeons and patients, examining the communication and decision-making process, and conduct individual interviews with 10-15 patients and 10-15 healthcare professionals. Patients will be interviewed at two time points: firstly as soon as possible after they discuss the possibility of leg amputation with a surgeon, and secondly around six months later. The investigators will identify what is important to patients, what information they need to make an informed decision and how best to communicate that information. Interviews with surgeons, anaesthetists and specialist physiotherapists will explore how they estimate risks and outcomes of amputation surgery, and how they communicate this to patients. Finally, the investigators will combine all this information together and discuss our findings with groups of patients and healthcare professionals, to identify key areas around amputation decision-making that can be improved and how best to further examine those areas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are eligible for the study if they meet all of the following inclusion criteria and none of the exclusion criteria apply. All queries about participant eligibility should be directed to the Qualitative Researcher. We will purposively sample participants from up to four participating NHS Health Boards / Trusts in Wales and England. We will aim to include 8-10 surgeons, 1-3 anaesthetists and 1-3 specialist physiotherapists from several Health Boards / Trusts. We will purposively sample patients for inclusion in the audio-recorded consultations and interviews to ensure our sample has variation in terms of gender, age, MLLA type (above knee/below knee/no amputation) and Health Board / Trust.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient aged 18 years old or over with chronic limb threatening ischaemia or diabetic foot disease for whom major lower limb amputation is considered or discussed\n* Vascular surgeons / anaesthetists / specialist physiotherapists involved in, or supporting major lower limb amputation decision making\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients undergoing major lower limb amputation for other causes (e.g. trauma or cancer)\n* Any patient/healthcare professional unable or unwilling to provide informed consent. Some patients undergoing emergency major lower limb amputation will have insufficient time to give informed consent\n* Potential participants with an insufficient understanding of English or Welsh to be able to provide informed consent\n* Potential participants unable to complete an interview in English'}, 'identificationModule': {'nctId': 'NCT04903756', 'acronym': 'PERCEIVE', 'briefTitle': 'The PERCEIVE Study', 'organization': {'class': 'OTHER', 'fullName': 'Aneurin Bevan University Health Board'}, 'officialTitle': 'Prediction of Risk and Communication of Outcome Following Major Lower Limb Amputation - a Collaborative Study (PERCEIVE). A Multi-methods Study of Risk Perception, Communication and the Extent and Experiences of Shared Decision Making Around the Time of Major Lower Limb Amputation.', 'orgStudyIdInfo': {'id': 'AB/136'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Adult patients where major lower limb amputation is being considered.'}, {'label': 'Healthcare professionals', 'description': 'Surgeons, anaesthetists, and allied health professionals involved in decision making with patients where a major lower limb amputation is being considered.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NP20 2UB', 'city': 'Newport', 'country': 'United Kingdom', 'facility': 'Aneurin Bevan University Health Board', 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aneurin Bevan University Health Board', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health and Care Research Wales', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Brenig Llwyd Gwilym', 'investigatorAffiliation': 'Aneurin Bevan University Health Board'}}}}