NCT07592845

Brief Summary

The goal of this observational, prospective cohort study is to learn more about fatigue after burn injury and how it associates with daily activities, health-related quality of life, and return to work. The study is based on data from adult patients who come for follow-up at the Burn Centre's outpatient clinic at Uppsala university hospital 6- and 12 months post-burn. Patients who come for follow-up are routinely asked to fill out several questionnaires to detect any problems that might have occurred due to the burn injury. Apart from ordinary assessments the study participants were asked to fill out three additional questionnaires. Data from questionnaires together with patient characteristics will be analysed and compiled and presented in a scientific article.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 19, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

5.3 years

First QC Date

May 11, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

Burn injuryFatigueActivities of daily livingHealth-related quality of lifeReturn to workOccupational therapy

Outcome Measures

Primary Outcomes (3)

  • Fatigue Severity Scale

    Fatigue Severity Scale (FSS) is a uni-dimensional self-assessment scale that measures the impact of fatigue on daily activities. The questionnaire includes nine statements on a seven-point Likert rating scale, from 1 ("completely disagree") to 7 ("completely agree"). Scores ≥ 4 indicate fatigue.

    6 and 12 months post-burn.

  • Performance and Satisfaction in Activities of Daily Living (PS-ADL)

    PS-ADL evaluates activity performance. The patient assesses 39 daily activities, the difficulty with which the activity is performed and how satisfied the patient is with how the activity is performed. The total score ranges from 0 to 3, the higher the score the more problem with activity performance.

    6 and 12 months post-burn.

  • Return to work

    Return to work was assessed through a couple of questions regarding current employment/studies/retirement alternatively sick leave, including the patient's own experience of the cause for it. The data presented in this study includes a) back to work/studies on part or full time, b) on sick leave or c) retired.

    6 and 12 months post-burn.

Secondary Outcomes (2)

  • Hospital Anxiety and Depression Scale (HADS)

    6 and 12 months post-burn.

  • The Patient and Observer Scar Assessment Scale (POSAS)

    6 and 12 months post-burn.

Eligibility Criteria

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

All consecutive patients scheduled for follow-up at the Burn center's outpatient clinic in Uppsala 6 ±3 months post burn were asked to participate in the study.

You may qualify if:

  • ≥ 18 years;
  • treated at the Burn unit at least 24 hours and
  • managed Swedish verbally and in writing

You may not qualify if:

  • any underlying disease that made it impossible to complete the questionnaires, or
  • the patient chose to abstain the routine 12-month follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, Burn Center

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (14)

  • Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.

  • Gabbe BJ, Cleland H, Watterson D, Schrale R, McRae S, Taggart S, Darton A, Wood F, Edgar DW; BRANZ Adult Long Term Outcomes pilot project participating sites and working party. Predictors of moderate to severe fatigue 12 months following admission to hospital for burn: Results from the Burns Registry of Australia and New Zealand (BRANZ) Long Term Outcomes project. Burns. 2016 Dec;42(8):1652-1661. doi: 10.1016/j.burns.2016.08.036. Epub 2016 Oct 27.

  • Thibaut A, Shie VL, Ryan CM, Zafonte R, Ohrtman EA, Schneider JC, Fregni F. A review of burn symptoms and potential novel neural targets for non-invasive brain stimulation for treatment of burn sequelae. Burns. 2021 May;47(3):525-537. doi: 10.1016/j.burns.2020.06.005. Epub 2020 Jun 20.

  • Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.

  • Simko LC, Espinoza LF, McMullen K, Herndon DN, Suman O, Fauerbach JA, Kowalske K, Wiechman S, Kazis LE, Ryan CM, Schneider JC. Fatigue Following Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2018 Apr 20;39(3):450-456. doi: 10.1097/BCR.0000000000000625.

  • Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  • Oster C, Willebrand M, Dyster-Aas J, Kildal M, Ekselius L. Validation of the EQ-5D questionnaire in burn injured adults. Burns. 2009 Aug;35(5):723-32. doi: 10.1016/j.burns.2008.11.007. Epub 2009 Mar 17.

  • Archenholtz B, Dellhag B. Validity and reliability of the instrument Performance and Satisfaction in Activities of Daily Living (PS-ADL) and its clinical applicability to adults with rheumatoid arthritis. Scand J Occup Ther. 2008 Mar;15(1):13-22. doi: 10.1080/11038120701223165.

  • Rossi D, Galant LH, Marroni CA. PSYCHOMETRIC PROPERTY OF FATIGUE SEVERITY SCALE AND CORRELATION WITH DEPRESSION AND QUALITY OF LIFE IN CIRRHOTICS. Arq Gastroenterol. 2017 Dec;54(4):344-348. doi: 10.1590/S0004-2803.201700000-85. Epub 2017 Oct 2.

  • Learmonth YC, Dlugonski D, Pilutti LA, Sandroff BM, Klaren R, Motl RW. Psychometric properties of the Fatigue Severity Scale and the Modified Fatigue Impact Scale. J Neurol Sci. 2013 Aug 15;331(1-2):102-7. doi: 10.1016/j.jns.2013.05.023. Epub 2013 Jun 20.

  • Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.

  • Machado MO, Kang NC, Tai F, Sambhi RDS, Berk M, Carvalho AF, Chada LP, Merola JF, Piguet V, Alavi A. Measuring fatigue: a meta-review. Int J Dermatol. 2021 Sep;60(9):1053-1069. doi: 10.1111/ijd.15341. Epub 2020 Dec 10.

Related Links

MeSH Terms

Conditions

BurnsFatigue

Condition Hierarchy (Ancestors)

Wounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational therapist, PhD

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 18, 2026

Study Start

May 19, 2020

Primary Completion

August 19, 2025

Study Completion

August 19, 2025

Last Updated

May 18, 2026

Record last verified: 2026-05

Locations