An observational study in Amputation, Peripheral Artery Disease and Diabetes Mellitus, sponsored by Aneurin Bevan University Health Board. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Aneurin Bevan University Health Board · 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.
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.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 30 is below the median of 188 across 398 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Aneurin Bevan University Health Board is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients where major lower limb amputation is being considered.
Surgeons, anaesthetists, and allied health professionals involved in decision making with patients where a major lower limb amputation is being considered.
Analysis of audio-recorded consultations between surgeons and patients.
Theme-oriented discourse analysis
Time frame: During primary consultation
Analysis of patient interviews
Thematic analysis of interview transcripts
Time frame: As soon as possible after the time of consultation and approximately 6 months following consultation
Analysis of healthcare professional interviews
Thematic analysis of interview transcripts
Time frame: As soon as possible after the time of consultation
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Dec 2022, 26 months.
Of 138 non-industry observational studies under Peripheral Arterial Disease, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's 26 months is below that.
Counting every sponsor, half of 196 studies reached it within 36 months; a quarter within 22 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Aneurin Bevan University Health Board