Work Productivity and Social Activities In Patients With Ankylosing Spondylitis
7. februar 2021 oppdatert av: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
The Relationship Between The Decreasing Activity, Depression And Quality Of Life In Work Productivity And Social Activities In Ankylosing Spondylitis Patients: A Randomized Controlled Trial
The aim of this study is to evaluate the relationship between decrease in work productivity and social activities in patients with Ankylosing Spondylitis (AS) with disease activity, depression and quality of life together with demographic data.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
For this study, which is planned as a cross-sectional clinical study, 100 patients who were diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age.
was included.
Demographic data of the participants were recorded.
Work productivity and activity reduction questionnaire: general health (WPAI: GH), social role participation questionnaire short form (SRPQ), short form-36 (SF-36), hospital anxiety, and depression scale (HADS), will be evaluated.
Besides, if the patient group exists, laboratory results (CRP, erythrocyte sedimentation rate, HLA-B27), and bath ankylosing spondylitis functional index (BASFI), bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis metrology index (BASMI), visual analog scale (VAS) resting, night and activity values were recorded.
Studietype
Observasjonsmessig
Registrering (Faktiske)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia
- Derya Bugdayci, Assoc Prof
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
For this study, which is planned as a cross-sectional clinical study, 100 patients who were diagnosed with AS between the ages of 18-65 and who applied to the Istanbul Physical Therapy Rehabilitation SUAM Physical Medicine and Rehabilitation Outpatient Clinic between April 15, 2019, and April 15, 2020, and 100 healthy volunteers compatible with age was included.
Beskrivelse
Inclusion Criteria:
- Patients with AS diagnosis between the ages of 18-65
- Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease
Exclusion Criteria:
- Those with serious systemic diseases that may interfere with working (respiratory system, cardiovascular system, renal and metabolic diseases)
- Those with orthopedic and psychiatric diseases
- Those with inflammatory diseases other than known AS
- Pregnant
- People with disability due to the history of trauma
- Those with injury after the operation
- Those with diseases that cause neurological sequelae
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Ankylosing Spondylitis
100 patients who were diagnosed with AS between the ages of 18-65
|
|
Healthy Volunteers
100 healthy volunteers compatible with age.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
Tidsramme: One day
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WPAI: GH measures health impact and symptom severity impact on work productivity and leave time effectiveness
|
One day
|
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Social Role Participation Questionnaire (SRPQ)
Tidsramme: One day
|
It is used to evaluate integration into society and activities in social life.
It evaluates the level of participation in six social roles in two dimensions: the "experienced physical difficulties scale" and the "role performance satisfaction scale".
Participants complete their satisfaction and challenges during their social roles
|
One day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Short Form Health Survey 36 (SF-36)
Tidsramme: One day
|
used to evaluate the quality of life
|
One day
|
|
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: One day
|
used to determine the risk in terms of anxiety and depression in a patient with a physical illness, and to measure the level and change of severity.
|
One day
|
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Tidsramme: One day
|
the assessment of disease activity in patients with ankylosing spondylitis
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One day
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Bath Ankylosing Spondylitis Functional Index (BASFI)
Tidsramme: One day
|
the assessment of functional status in patients with ankylosing spondylitis
|
One day
|
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Bath Ankylosing Spondylitis Metrology Index (BASMI)
Tidsramme: One day
|
the assessment of the level of spinal mobility in patients with ankylosing spondylitis
|
One day
|
|
Ankylosing Spondylitis Quality of Life (ASQoL)
Tidsramme: One day
|
used to evaluate the quality of life in patients with ankylosing spondylitis
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One day
|
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Visual Analogue Scale (VAS)
Tidsramme: One day
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used to evaluate the pain
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One day
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Ömer Faruk Bucak, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Macfarlane GJ, Shim J, Jones GT, Walker-Bone K, Pathan E, Dean LE. Identifying Persons with Axial Spondyloarthritis At Risk of Poor Work Outcome: Results from the British Society for Rheumatology Biologics Register. J Rheumatol. 2019 Feb;46(2):145-152. doi: 10.3899/jrheum.180477. Epub 2018 Nov 1. Erratum In: J Rheumatol. 2019 Jul;46(7):867-868.
- Goh Y, Kwan YH, Leung YY, Fong W, Cheung PP. A cross-sectional study on factors associated with poor work outcomes in patients with axial spondyloarthritis in Singapore. Int J Rheum Dis. 2019 Nov;22(11):2001-2008. doi: 10.1111/1756-185X.13696. Epub 2019 Oct 1.
- Sag S, Nas K, Sag MS, Tekeoglu I, Kamanli A. Relationship of work disability between the disease activity, depression and quality of life in patients with ankylosing spondylitis. J Back Musculoskelet Rehabil. 2018;31(3):499-505. doi: 10.3233/BMR-169657.
- van Lunteren M, Ez-Zaitouni Z, Fongen C, Landewe R, Ramonda R, van der Heijde D, van Gaalen FA. Disease activity decrease is associated with improvement in work productivity over 1 year in early axial spondyloarthritis (SPondyloArthritis Caught Early cohort). Rheumatology (Oxford). 2017 Dec 1;56(12):2222-2228. doi: 10.1093/rheumatology/kex365.
- Oude Voshaar M, van Onna M, van Genderen S, van de Laar M, van der Heijde D, Heuft L, Spoorenberg A, Luime J, Gignac M, Boonen A. Development and Validation of a Short Form of the Social Role Participation Questionnaire in Patients with Ankylosing Spondylitis. J Rheumatol. 2016 Jul;43(7):1386-92. doi: 10.3899/jrheum.151013. Epub 2016 May 15.
- van Genderen S, Plasqui G, Landewe R, Lacaille D, Arends S, van Gaalen F, van der Heijde D, Heuft L, Luime J, Spoorenberg A, Gignac M, Boonen A. Social Role Participation in Patients With Ankylosing Spondylitis: A Cross-Sectional Comparison With Population Controls. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1899-1905. doi: 10.1002/acr.22907. Epub 2016 Oct 28.
- Cakar E, Taskaynatan MA, Dincer U, Kiralp MZ, Durmus O, Ozgul A. Work disability in ankylosing spondylitis: differences among working and work-disabled patients. Clin Rheumatol. 2009 Nov;28(11):1309-14. doi: 10.1007/s10067-009-1249-1. Epub 2009 Aug 16.
- Maksymowych WP, Gooch KL, Wong RL, Kupper H, van der Heijde D. Impact of age, sex, physical function, health-related quality of life, and treatment with adalimumab on work status and work productivity of patients with ankylosing spondylitis. J Rheumatol. 2010 Feb;37(2):385-92. doi: 10.3899/jrheum.090242. Epub 2009 Dec 1.
- Deodhar AA, Dougados M, Baeten DL, Cheng-Chung Wei J, Geusens P, Readie A, Richards HB, Martin R, Porter B. Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis: A Phase III Randomized Trial (MEASURE 1). Arthritis Rheumatol. 2016 Dec;68(12):2901-2910. doi: 10.1002/art.39805.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. april 2019
Primær fullføring (Faktiske)
15. april 2020
Studiet fullført (Faktiske)
15. desember 2020
Datoer for studieregistrering
Først innsendt
7. februar 2021
Først innsendt som oppfylte QC-kriteriene
7. februar 2021
Først lagt ut (Faktiske)
11. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. februar 2021
Sist bekreftet
1. februar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IstPRMTRH-ASWP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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