Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

NCT05860764 | Unknown

• 1 other identifier: 0873
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Disease, Peripheral; Amputation; Physical Disability

Outcome Measures

Primary Outcomes (1)

• qualitative theme identification

  qualitative themes will be identified after data collection through qualitative interviews and focus groups and thematic analysis has taken place

  baseline

Study Arms (1)

vascular amputees and healthcare professionals

participants who have undergone an amputation due to peripheral arterial disease and healthcare professionals who treat these participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Undergone major lower limb amputation due to peripheral arterial disease and/or diabetes at any time point
• Planned date for major lower limb amputation within 1 week of consent due to peripheral arterial disease and/or diabetes

You may not qualify if:

• 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:
• 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
• No experience of working with vascular amputee patients
• Unable to speak or write English

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Department of Cardiovascular Sciences, University of Leicester

Leicester, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Miss Essop-Adam

CONTACT

+44 (0)116 258 3473; aea19@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: May 16, 2023
• Study Start: February 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)