NCT06059183

Brief Summary

The Functional Assessment for Burns (FAB) score is an instrument developed by therapists at St Andrew's Burns Centre, Mid Essex Hospital Services NHS Trust, where it is currently used as standard protocol to measure the physical functional recovery and independence of adult burn inpatients. The aim of this research is to test the ability of the FAB score to collect accurate data when used by three different therapists observing the same patient carrying out specific functional tasks (i.e. inter-rater reliability).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

August 24, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

Inter-rater reliabilityFunctional Assessment for Burns

Outcome Measures

Primary Outcomes (1)

  • Level of inter-rater reliability of the Functional Assessment for Burns (FAB) score

    Inter-rater reliability of the FAB score when used by three different therapists observing the same patient scoring episode, expressed as Intraclass Correlation Coefficient (ICC). The FAB score consists of seven daily activities including: feeding, washing, toileting, transfers, dressing, walking and stair climbing. Patients are scored on a numerical scale from 1-5 based on their ability to complete each activity independently, or on the minimum amount of assistance required to complete each task. The total score ranges between 7 (fully dependent) and 35 (fully independent).

    As per protocol at St Andrew's: FAB 1 taken within 48 hours admission to burns ward; FAB 2 taken within 48 hours discharge from burns ward; interim FAB scores taken at therapists' discretion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients aged 18 years and over admitted to St Andrew's adult burns ward

You may qualify if:

  • Male and female adult patients admitted to St Andrew's burns ward with burn injuries
  • ≥18 years old

You may not qualify if:

  • Patients admitted with medical skin loss conditions
  • Unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Smailes ST, Engelsman K, Rodgers L, Upson C. Increasing the utility of the Functional Assessment for Burns Score: Not just for major burns. Burns. 2016 Feb;42(1):163-168. doi: 10.1016/j.burns.2015.09.020. Epub 2015 Oct 25.

    PMID: 26508532BACKGROUND
  • Smailes ST, Engelsman K, Dziewulski P. Physical functional outcome assessment of patients with major burns admitted to a UK Burn Intensive Care Unit. Burns. 2013 Feb;39(1):37-43. doi: 10.1016/j.burns.2012.05.007. Epub 2012 Jun 6.

    PMID: 22677162BACKGROUND
  • Eagan JH, Ramdharry G, Smailes ST. Investigating the interrater reliability of a novel functional outcome measure for use in the burns intensive care unit: The Functional Assessment for Burns - Critical Care (FAB-CC). Burns. 2020 Mar;46(2):279-285. doi: 10.1016/j.burns.2018.12.004. Epub 2018 Dec 27.

    PMID: 30595543BACKGROUND
  • Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010 Mar 18;10:22. doi: 10.1186/1471-2288-10-22.

    PMID: 20298572BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Sarah Smailes, PhD

CONTACT

Catherine Wharfe, MSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 24, 2023

First Posted

September 28, 2023

Study Start

February 1, 2024

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in the study, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.