NCT06948968

Brief Summary

Participation, as defined by the International Classification of Functioning, Disability, and Health (ICF), refers to "engagement in a life situation" and is a key component of functional health beyond physical impairments or activity limitations. Social role participation encompasses various aspects of life, including work, family commitments, social interactions, and leisure activities. Ankylosing Spondylitis (AS), a chronic inflammatory disease affecting the axial skeleton, significantly impacts patients' ability to maintain social roles due to pain, stiffness, and reduced mobility. Existing studies highlight limitations in employment, relationships, education, and leisure activities among AS patients. While various scales assess participation, the Social Role Participation Questionnaire (SRPQ) uniquely emphasizes subjective aspects such as role importance and satisfaction with performance. Although validated versions of the SRPQ exist in English, Dutch, and Chinese populations, no culturally adapted tool is available for Turkish-speaking AS patients. This study aims to translate the SRPQ into Turkish and evaluate its validity and reliability as a culturally appropriate instrument for assessing social role participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

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

December 24, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3.9 years

First QC Date

March 12, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Ankylosing SpondylitisParticipationSocial Role ParticipationSRPQTurkish Adaptation

Outcome Measures

Primary Outcomes (2)

  • Reliability of the Turkish Version of the Adapted Social Role Participation Questionnaire (SRPQ) in Ankylosing Spondylitis

    To assess reliability, the Social Role Participation Questionnaire (SRPQ) was completed twice by the same participants in a quiet room at two-week intervals. Internal consistency was evaluated using Cronbach's alpha (α ≥ 0.70, acceptable), and test-retest reliability was assessed using the Intraclass Correlation Coefficient (ICC ≥ 0.85, excellent), based on a two-way mixed-effects model with absolute agreement. The SRPQ includes three dimensions: Role Importance (1-5), Satisfaction with Performance (1-5), and Physical Difficulty (1-4). Higher scores on Role Importance and Satisfaction indicate better perceived participation, while higher scores on Physical Difficulty reflect greater difficulty in performing roles.

    2018-2022

  • Validity of the Turkish Version of the Adapted Social Role Participation Questionnaire (SRPQ) in Ankylosing Spondylitis

    Construct validity was evaluated by correlating SRPQ scores with three validated instruments: the Ankylosing Spondylitis Quality of Life Scale (ASQoL), Short Form-36 Health Survey (SF-36), and Work Productivity and Activity Impairment Questionnaire (WPAI). ASQoL (0-18) assesses disease-specific quality of life, with higher scores reflecting greater impairment. SF-36 covers eight health domains (0-100), with higher scores indicating better health. Participation was captured in the social functioning, role-physical, and role-emotional domains. The WPAI (0-100%) measures work productivity and activity impairment over the prior week, with higher percentages indicating greater disability. Spearman correlation coefficients were used and interpreted as poor (\<0.20), fair (0.21-0.40), moderate (0.41-0.60), very good (0.61-0.80), or excellent (\>0.81). The scoring directionality of each scale supports the interpretation of SRPQ's convergent and discriminant validity.

    2018-2022

Interventions

Validity and Reliability of the Turkish Version of the Adapted Social Role Participation Questionnaire in Ankylosing Spondylitis

Eligibility Criteria

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

Primary care clinic

You may qualify if:

  • Clinical diagnosis of AS according to the modified New York criteria
  • Being over 18 years old
  • To comprehend Turkish and communicate fluently in the Turkish language

You may not qualify if:

  • Having severe psychiatric conditions
  • Concomitant severe medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (8)

  • Jimenez Bunuales MT, Gonzalez Diego P, Martin Moreno JM. [International classification of functioning, disability and health (ICF) 2001]. Rev Esp Salud Publica. 2002 Jul-Aug;76(4):271-9. doi: 10.1590/s1135-57272002000400002. Spanish.

    PMID: 12216167BACKGROUND
  • Davis AM, Palaganas MP, Badley EM, Gladman DD, Inman RD, Gignac MA. Measuring participation in people with spondyloarthritis using the social role participation questionnaire. Ann Rheum Dis. 2011 Oct;70(10):1765-9. doi: 10.1136/ard.2010.149211. Epub 2011 Jul 25.

    PMID: 21791450BACKGROUND
  • Sieper J, Braun J, Rudwaleit M, Boonen A, Zink A. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002 Dec;61 Suppl 3(Suppl 3):iii8-18. doi: 10.1136/ard.61.suppl_3.iii8.

    PMID: 12381506BACKGROUND
  • van Echteld I, Cieza A, Boonen A, Stucki G, Zochling J, Braun J, van der Heijde D. Identification of the most common problems by patients with ankylosing spondylitis using the international classification of functioning, disability and health. J Rheumatol. 2006 Dec;33(12):2475-83. Epub 2006 Oct 15.

    PMID: 17013999BACKGROUND
  • Gignac MA, Backman CL, Davis AM, Lacaille D, Mattison CA, Montie P, Badley EM. Understanding social role participation: what matters to people with arthritis? J Rheumatol. 2008 Aug;35(8):1655-63. Epub 2008 Jun 15.

    PMID: 18597401BACKGROUND
  • Dijkers MP. Issues in the conceptualization and measurement of participation: an overview. Arch Phys Med Rehabil. 2010 Sep;91(9 Suppl):S5-16. doi: 10.1016/j.apmr.2009.10.036.

    PMID: 20801280BACKGROUND
  • van Genderen S, Plasqui G, Lacaille D, Arends S, van Gaalen F, van der Heijde D, Heuft L, Keszei A, Luime J, Spoorenberg A, Landewe R, Gignac M, Boonen A. Social Role Participation Questionnaire for patients with ankylosing spondylitis: translation into Dutch, reliability and construct validity. RMD Open. 2016 Feb 1;2(1):e000177. doi: 10.1136/rmdopen-2015-000177. eCollection 2016.

    PMID: 26870393BACKGROUND
  • Zhang G, Li J, Liu D, Wang T, Wang Y, Xu W. Translation and validation of the Chinese Social Role Participation Questionnaire in patients with ankylosing spondylitis. Clin Rheumatol. 2018 Mar;37(3):655-660. doi: 10.1007/s10067-017-3915-z. Epub 2017 Nov 18.

    PMID: 29151172BACKGROUND

Related Links

MeSH Terms

Conditions

Spondylitis, AnkylosingPatient Participation

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof Dr

Study Record Dates

First Submitted

March 12, 2025

First Posted

April 29, 2025

Study Start

December 24, 2018

Primary Completion

November 29, 2022

Study Completion

March 28, 2023

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations