- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07592845
Fatigue After Burn
Fatigue After Burn - Associations With Daily Activities, Health-related Quality of Life, and Return to Work
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.
Přehled studie
Postavení
Podmínky
Detailní popis
Physical function and daily activities are often affected after a burn injury. Previous research show complications that significantly affect the recovery, such as pain, muscle weakness, scar contractures, hypertrophic scarring, psychosocial problems, and fatigue. The symptoms decrease with time but 26 % still experience fatigue one year post burn and some patients never return to the same level as before the burn injury.
The association between fatigue and different variables has been investigated when it comes to burn patients. Various studies observe a connection between major burns (≥20 % TBSA, the Total Body Surface Area of burnt skin in %) and gender. Associations between fatigue and age, burn depth, and cause of injury show varying/contradictory results. Associations between fatigue and depression have also been observed since the symptoms of fatigue and depression are similar and sometimes overlapping. Edwards et al. show a significant correlation between anxiety/depression and fatigue, and depression one year post burn is reported in 10 - 23 % of the patients.
To increase the knowledge about rehabilitation after burn injury and how fatigue affects daily life post burn the present work aims to investigate to what extent fatigue is a problem among Swedish burn victims. International research is available, but more knowledge is needed to increase the opportunity to help and guide patients towards a more meaningful and manageable daily life.
Objectives Primary objective: to investigate the association between fatigue and
- activity performance,
- health-related quality of life and
- return to work at 6 months, and 12 months post-burn
Secondary objectives:
- To examine whether fatigue is associated with anxiety and depression scores
- To determine if subjective scar assessment is associated with fatigue levels
- To evaluate if intubation during initial treatment is associated with subsequent fatigue
This is a prospective cohort study based on data from patients who suffered a burn injury and were admitted as inpatients to the Burn Centre at Uppsala University Hospital between May 2020 and August 2025. All patients who came for follow-up 6 months after their burn injury were asked to participate, if they fulfilled the inclusion criteria and no exclusion criteria.
Eighty-five patients were enrolled in this study. The number based on a power calculation made in SPSS for Windows, with a desired power of 0.9, a Spearman correlation parameter of 0.4 and a statistical significance level of 0.05. The variance was estimated by the method proposed by Bonett and Wright and the number of patients recommended was 67, at a minimum. All the included patients' have given their written and informed consent.
Outcome definitions The patients are routinely asked to fill out several questionnaires to detect any problems that might have occurred after the burn injury. Apart from ordinary routine assessments the study participants are asked to fill out three additional questionnaires at each follow-up visit. The questionnaires (described in another section) will be handed out to the participants at two time-points, at the 6- and 12-months follow-up visits.
If the patient cannot fill out the questionnaires in connection with the follow-up visit, they may bring them home and return the completed questionnaires in a return envelope as soon as possible after the visit. Should the patient cancel the 12-month follow-up visit they will be contacted by phone and asked if they might consider filling out the questionnaires if they are sent home by mail.
Data analysis Data will be analysed collectively when all the included patients have had their last follow-up at 12 months and all the data have been registered. Data will be analysed using IBM SPSS Statistics for Windows (version 23, IBM Corp, Armonk, NY, USA). The threshold for statistical significance is p<0.05. All confidence intervals presented will be 95%.
Data will be analysed and compared in the following sub-groups:
- Without fatigue, FSS <4, with fatigue, FSS ≥4, with results from each time point.
- %TBSA, minor burns <20% TBSA/major burns ≥20% TBSA. Data will be presented as mean, range, standard deviation, and confidence interval. To assess changes over time, between the two time points, 6- and 12-months post-burn, the results will be analysed using dependent t-test for continuous data, and Wilcoxon signed-rank test for nominal or ordinal data.
A Generalized Linear Mixed Model analysis (GLMM) will be performed to assess the associations between FSS and other variables: EQ VAS, POSAS, HADS anxiety, HADS depression, TBSA %, and PS-ADL.
Patient characteristics such as age, gender, marital status, % total body surface area (%TBSA) burned, length of stay (LOS), surgery, and intubation will be collected from the patients' medical records and presented in a table with demographics, using descriptive statistics; means, range, percentage, and standard deviation, where applicable.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Uppsala County
-
Uppsala, Uppsala County, Švédsko, 75185
- Uppsala University Hospital, Burn Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- ≥ 18 years;
- treated at the Burn unit at least 24 hours and
- managed Swedish verbally and in writing
Exclusion Criteria:
- any underlying disease that made it impossible to complete the questionnaires, or
- the patient chose to abstain the routine 12-month follow-up.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Fatigue Severity Scale
Časové okno: 6 and 12 months post-burn.
|
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)
Časové okno: 6 and 12 months post-burn.
|
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
Časové okno: 6 and 12 months post-burn.
|
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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Časové okno: 6 and 12 months post-burn.
|
HADS a valid self-assessment scale evaluating anxiety and depression.
The HADS involves fourteen statements, seven relate to anxiety and seven to depression.
The scores sum up to 21 in each subscale, ≥11 means that depression/anxiety is likely present.
The assessment was used in this study as a screening of the patient's mental well-being since the symptoms of fatigue and anxiety/depression sometimes overlap
|
6 and 12 months post-burn.
|
|
The Patient and Observer Scar Assessment Scale (POSAS)
Časové okno: 6 and 12 months post-burn.
|
POSAS consists of two scales: the observer scale and the patient scale.
In this study only the patient scale is included.
The patient scale consists of six items (pain, itch, colour, stiffness, thickness, irregularity) which sum up to a total score.
The patient is also asked to give an overall opinion.
Each item is rated on a 10-point scale, ranging from 1 (no, not at all/no, as normal skin) to 10 (yes, very much/yes, very different).
|
6 and 12 months post-burn.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- 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.
- 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.
- 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.
- 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.
- 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Fatigue burn
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Popálení Poranění
-
Stratatech, a Mallinckrodt CompanyDokončeno
-
Bartın UnıversityAktivní, ne náborTrpěliví | Burn (porucha)Turecko (Türkiye)
-
Chulalongkorn UniversityNational Science and Technology Development Agency, ThailandDokončenoDeep Partial Thickness BurnThajsko
-
GeneScience Pharmaceuticals Co., Ltd.Third Military Medical University; Shanghai Jiao Tong University School of... a další spolupracovníciDokončenoDeep Partial Thickness Burn
-
Central Arkansas Veterans Healthcare SystemUnited States Department of Defense; University of ArkansasNáborOtevřete Burn Pit ExposureSpojené státy
-
Stratatech, a Mallinckrodt CompanyDokončenoDeep Partial-thightness BurnSpojené státy
-
Cairo UniversityNábor
-
Cairo UniversityDokončeno
-
The First Affiliated Hospital of Xinxiang Medical...Zatím nenabírámeHořet | Druhý stupeň spálení | Burn kontraktura kůže
-
King Edward Medical UniversityAktivní, ne náborPost Burn Facial HyperpigmentationPákistán