Clinical trial NCT05860764: Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Disease, Peripheral
Amputation
Physical Disability
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 groups of participants in one cohort

* participants who have undergone an amputation due to peripheral arterial disease, 'vascular amputees'
* healthcare professionals that work with vascular amputees in clinical practice

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: qualitative theme identification
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Department of Cardiovascular Sciences, University of Leicester
Study officials:
References: