Vascular Amputee Physical Performance Qualitative (VAmPP-Q) Study

Sponsor
University of Leicester (Other)
Overall Status
Recruiting
CT.gov ID
NCT05860764
Collaborator
(none)
30
1
19
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    vascular amputees and healthcare professionals

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

    Outcome Measures

    Primary Outcome Measures

    1. qualitative theme identification [baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Cardiovascular Sciences, University of Leicester Leicester United Kingdom

    Sponsors and Collaborators

    • University of Leicester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Leicester
    ClinicalTrials.gov Identifier:
    NCT05860764
    Other Study ID Numbers:
    • 0873
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2023