Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

Study Overview
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Brief Summary
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Background: 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.

Official Title
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Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study: Exploratory Study Investigating Perceptions and Experience of Physical Performance and Physical Assessment of Vascular Amputees Using Performance Based Outcome Measures

Conditions
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Vascular Disease, Peripheral, Amputation, Physical Disability

Participation Criteria
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Eligibility Criteria
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Vascular amputee group: Inclusion criteria Undergone major lower limb amputation due to peripheral arterial disease and/or diabetes at any time point or Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes Exclusion criteria Has/will undergo a minor amputation only 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: Inclusion criteria • 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 No experience of working with vascular amputee patients Unable to speak or write English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vascular amputees and healthcare professionals<br>participants who have undergone an amputation due to peripheral arterial disease and healthcare professionals who treat these participants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualitative theme identification | qualitative themes will be identified after data collection through qualitative interviews and focus groups and thematic analysis has taken place | baseline |