Diabetes Mellitus Clinical Trial
— PERCEIVEOfficial title:
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.
Verified date | November 2022 |
Source | Aneurin Bevan University Health Board |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2023 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - Vascular surgeons / anaesthetists / specialist physiotherapists involved in, or supporting major lower limb amputation decision making Exclusion Criteria: - Patients under 18 years old - Patients undergoing major lower limb amputation for other causes (e.g. trauma or cancer) - 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 - Potential participants with an insufficient understanding of English or Welsh to be able to provide informed consent - Potential participants unable to complete an interview in English |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aneurin Bevan University Health Board | Newport |
Lead Sponsor | Collaborator |
---|---|
Aneurin Bevan University Health Board | Health and Care Research Wales |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analysis of audio-recorded consultations between surgeons and patients. | Theme-oriented discourse analysis | During primary consultation | |
Secondary | Analysis of patient interviews | Thematic analysis of interview transcripts | As soon as possible after the time of consultation and approximately 6 months following consultation | |
Secondary | Analysis of healthcare professional interviews | Thematic analysis of interview transcripts | As soon as possible after the time of consultation |
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