NCT04749537

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

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

April 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 7, 2021

Last Update Submit

February 7, 2021

Conditions

Ankylosing SpondylitisWork Productivity

Keywords

SpondylitisAnkylosingQuality of LifeEmployment

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Short Form Health Survey 36 (SF-36)

    One day

  • Hospital Anxiety and Depression Scale (HADS)

    One day

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    One day

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    One day

  • Bath Ankylosing Spondylitis Metrology Index (BASMI)

    One day

  • +2 more secondary outcomes

Study Arms (2)

Ankylosing Spondylitis

100 patients who were diagnosed with AS between the ages of 18-65

Healthy Volunteers

100 healthy volunteers compatible with age.

Eligibility Criteria

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

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.

You may qualify if:

  • Patients with AS diagnosis between the ages of 18-65
  • Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derya Bugdayci, Assoc Prof

Istanbul, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

    PMID: 30385702BACKGROUND

  • 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.

    PMID: 31576680BACKGROUND

  • 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.

    PMID: 29504521BACKGROUND

  • 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.

    PMID: 29155961BACKGROUND

  • 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.

    PMID: 27182067BACKGROUND

  • 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.

    PMID: 27059161BACKGROUND

  • 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.

    PMID: 19685294BACKGROUND

  • 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.

    PMID: 19955052BACKGROUND

  • 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.

    PMID: 27390130BACKGROUND

MeSH Terms

Conditions

Spondylitis, AnkylosingSpondylitis

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBone Diseases, InfectiousInfections

Study Officials

  • Ömer Faruk Bucak, MD

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2021

First Posted

February 11, 2021

Study Start

April 15, 2019

Primary Completion

April 15, 2020

Study Completion

December 15, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)