Work Productivity and Social Activities In Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749537
• Other study ID #: IstPRMTRH-ASWP
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: February 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing
• Work Productivity

Locations

Country	Name	City	State
Turkey	Derya Bugdayci, Assoc Prof	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Cakar E, Taskaynatan MA, Dincer U, Kiralp MZ, Durmus O, Ozgül 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

van Genderen S, Plasqui G, Landewé 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. — View Citation

van Lunteren M, Ez-Zaitouni Z, Fongen C, Landewé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)	WPAI: GH measures health impact and symptom severity impact on work productivity and leave time effectiveness	One day
Primary	Social Role Participation Questionnaire (SRPQ)	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
Secondary	Short Form Health Survey 36 (SF-36)	used to evaluate the quality of life	One day
Secondary	Hospital Anxiety and Depression Scale (HADS)	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
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	the assessment of disease activity in patients with ankylosing spondylitis	One day
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI)	the assessment of functional status in patients with ankylosing spondylitis	One day
Secondary	Bath Ankylosing Spondylitis Metrology Index (BASMI)	the assessment of the level of spinal mobility in patients with ankylosing spondylitis	One day
Secondary	Ankylosing Spondylitis Quality of Life (ASQoL)	used to evaluate the quality of life in patients with ankylosing spondylitis	One day
Secondary	Visual Analogue Scale (VAS)	used to evaluate the pain	One day