Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study
NCT ID: NCT05860764
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2023-02-01
2024-09-30
Brief Summary
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Peripheral arterial disease (PAD) is the main cause of amputation to the lower limb within the UK, affecting over 20% of adults older than 70 years.
After an amputation, individuals often use a wheelchair and do not walk with a prosthetic limb. This is due to them experiencing: older age, muscle weakness, pain, other health conditions limiting ability to exercise eg. heart problems.
Healthcare professionals assess physical function with Physical Performance Based Outcome Measures (PerBOMs). A PerBOM requires an individual to complete tasks that are part of their day to day life e.g. walking or balance.
PerBOMs are used with for:
* Setting goals with patients
* Assessing how patients respond to treatment/rehabilitation
* Predicting if patients are likely to use a prosthetic limb in the future
Previous research shows most of the available PerBOMs are suitable an amputee who walks with a prosthetic limb. However, most vascular amputee patients cannot benefit from these assessments.
Therefore, based on this evidence we have developed a new PerBOM to help manage vascular amputees who do not walk with a prosthetic limb.
Methods:
Qualitative interviews and focus groups with amputee individuals and healthcare professionals who treat them. Approaching individuals who have or will undergo an amputation to their leg due to PAD. Approaching healthcare professionals through professional networks.
Interviews and focus groups will take place face to face or remotely by telephone/video conferencing, lasting approximately 1-2 hrs.
In the interview or focus group, the researcher will explain and show individuals a video of the new PerBOM and explore their opinions qualitatively on this new PerBOM.
All audio will be recorded, written up and analysed. All findings will be presented at scientific conferences.
This study has been developed with patients and public involvement.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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vascular amputees and healthcare professionals
participants who have undergone an amputation due to peripheral arterial disease and healthcare professionals who treat these participants
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* or
* Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes
• Healthcare professional currently working with vascular amputees. Healthcare professional defined as qualified professional background e.g. HCPC, NMC or GMC registered or non-qualified professional background e.g. healthcare support worker
Exclusion Criteria
* Amputation due to alternative aetiology
* No plan for amputation to lower limb
* Unable to communicate or write in English
* Lacking capacity to consent to research study
* \>1 weeks or unspecified date for amputation surgery
* \<18 years
Healthcare professional group:
* No experience of working with vascular amputee patients
* Unable to speak or write English
18 Years
ALL
No
Sponsors
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University of Leicester
OTHER
Responsible Party
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Locations
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Department of Cardiovascular Sciences, University of Leicester
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0873
Identifier Type: -
Identifier Source: org_study_id
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