Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-03 @ 7:19 AM
Study NCT ID:
NCT04903756
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PERCEIVE Study
Sponsor:
Aneurin Bevan University Health Board
Organization:
Study Overview
Official 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.
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERCEIVE
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: