Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study (VAmPP-Q)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Physical Disability; Vascular Disease, Peripheral

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Miss Essop-Adam; Phone Number: +44 (0)116 258 3473; Email: aea19@leicester.ac.uk

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • Recruiting
    • Department of Cardiovascular Sciences, University of Leicester
    • Contact: Miss Essop-Adam; Phone Number: +44 (0)116 258 3473; Email: aea19@leicester.ac.uk
    • Contact: Miss Payne; Phone Number: +44 (0)116 258 3473; Email: tjp28@leicester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
vascular amputees and healthcare professionals; participants who have undergone an amputation due to peripheral arterial disease and healthcare professionals who treat these participants

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Leicester

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 0873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No