Ankylosing SpondylitisNCT06948968
Turkish Version of the Adapted Social Role Participation Questionnaire
An observational study of Ankylosing Spondylitis and Participation, Patient, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Participation, Patient
- What is being tested?
- Social Role Participation Questionnaire
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2018to 28 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- Having severe psychiatric conditions
- Concomitant severe medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Version of the Adapted Social Role Participation Questionnaire for Ankylosing Spondylitis: A Study on Its Validity and Reliability
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.
Read the detailed description
The International Classification of Functioning, Disability and Health (ICF) defines participation as "engagement in a life situation" viewing the concept of participation that a functional element beyond body functions and activity limitations. Role participation can be considered in a multifaceted manner. This includes not only participation in a role but but also perceptions of the role's importance, the assessment of limitations or challenges in-role performance, and satisfaction with the individual's ability to fulfill a role according to personal preference. Social role participation encompasses various aspects of an individual's life, including work, family commitments, social interactions, and leisure activities.
Ankylosing Spondylitis (AS), with its chronic, inflammatory, and progressive nature, primarily affects the sacroiliac joints and axial skeleton, leading to pain, joint stiffness, and reduced spinal mobility in individuals. Peripheral and extra-articular symptoms may also occur. Consequently, the physical function loss that develops in individuals reduces their quality of life and productivity, negatively impacting social role participation and the ability to maintain communal roles, affecting their overall well-being. According to the literature, it is documented that individuals with AS experience mild or greater limitations in areas such as recreation and leisure, social life, employment, close relationships, formal and informal social relationships, basic and complex interpersonal interactions, family relationships, education, and contributing to others' well-being.
Existing scales related to participation differ based on the roles they include and the social dimensions they asses (vary based on the different participation roles they include and the dimensions of social roles they measure). Unlike other participation scales that assess social role participation based on frequency, restriction, or role occupation, the SRPQ is a promising tool that emphasizes the assessment of an individual's subjective aspects, particularly their desires and satisfactions, across a wide range of roles in various dimensions. From an individual perspective, the "satisfaction" dimension is particularly noteworthy, as it can be linked to numerous aspects of participation performance and other qualitative dimensions. It provides additional insights into the personal assessment of role performance. Furthermore, the "importance of the role" dimension, which reflects the value an individual assigned to a role, serves as a potential factor that qualifies performance scores. Its direct assessment may offer a possible approach to studying response shift phenomena, which influence many of the subjective aspects of participation.
The English, Dutch, and Chinese versions of the SRPQ have been proven to be reliable and valid tools for measurement assessing social role participation in individuals with AS. Davis et al. have reported that this tool can also be used to evaluate the complex relationships between symptoms, disability, and participation, along with the personal and environmental contextual factors that influence them.
Currently, in Turkey, there is no valid and reliable tool that simultaneously evaluates the importance, physical difficulty, and satisfaction related to social role participation in individuals with AS. This study aims to translate the SRPQ, into Turkish as it encompasses all dimensions of social role participation, and to evaluate its validity and reliability among Turkish-speaking individuals with AS, thereby providing a culturally appropriate assessment tool.
- Conditions
- Ankylosing Spondylitis, Participation, Patient
- Being tested
- Social Role Participation Questionnaire
- Keywords
- Ankylosing Spondylitis, Participation, Social Role Participation, SRPQ, Turkish Adaptation
- Medical subject headings
- Spondylitis, Ankylosing, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Role Participation QuestionnaireOther
Validity and Reliability of the Turkish Version of the Adapted Social Role Participation Questionnaire in Ankylosing Spondylitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2018-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start24 Dec 2018
- Primary completion29 Nov 2022
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Gokbel, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948968
- Sponsor's protocol ID
- 6/56
- Status last verified
- May 2025
- First submitted
- 12 Mar 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12216167Davis 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.
PubMed 21791450Sieper 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.
PubMed 12381506van 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.
PubMed 17013999Gignac 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.
PubMed 18597401Dijkers 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.
PubMed 20801280van 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.
PubMed 26870393Zhang 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.
PubMed 29151172
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of the Adapted Social Role Participation Questionnaire for Ankylosing Spondylitis: A Study on Its Validity and Reliability
- ClinicalTrials.gov ID
- NCT06948968
- Acronym / sponsor ID
- 6/56
- Conditions
- Ankylosing Spondylitis, Participation, Patient
- Keywords
- Ankylosing Spondylitis, Participation, Social Role Participation, SRPQ, Turkish Adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The International Classification of Functioning, Disability and Health (ICF) defines participation as "engagement in a life situation" viewing the concept of participation that a functional element beyond body functions and activity limitations. Role participation can be considered in a multifaceted manner. This includes not only participation in a role but but also perceptions of the role's importance, the assessment of limitations or challenges in-role performance, and satisfaction with the individual's ability to fulfill a role according to personal preference. Social role participation encompasses various aspects of an individual's life, including work, family commitments, social interactions, and leisure activities.
Ankylosing Spondylitis (AS), with its chronic, inflammatory, and progressive nature, primarily affects the sacroiliac joints and axial skeleton, leading to pain, joint stiffness, and reduced spinal mobility in individuals. Peripheral and extra-articular symptoms may also occur. Consequently, the physical function loss that develops in individuals reduces their quality of life and productivity, negatively impacting social role participation and the ability to maintain communal roles, affecting their overall well-being. According to the literature, it is documented that individuals with AS experience mild or greater limitations in areas such as recreation and leisure, social life, employment, close relationships, formal and informal social relationships, basic and complex interpersonal interactions, family relationships, education, and contributing to others' well-being.
Existing scales related to participation differ based on the roles they include and the social dimensions they asses (vary based on the different participation roles they include and the dimensions of social roles they measure). Unlike other participation scales that assess social role participation based on frequency, restriction, or role occupation, the SRPQ is a promising tool that emphasizes the assessment of an individual's subjective aspects, particularly their desires and satisfactions, across a wide range of roles in various dimensions. From an individual perspective, the "satisfaction" dimension is particularly noteworthy, as it can be linked to numerous aspects of participation performance and other qualitative dimensions. It provides additional insights into the personal assessment of role performance. Furthermore, the "importance of the role" dimension, which reflects the value an individual assigned to a role, serves as a potential factor that qualifies performance scores. Its direct assessment may offer a possible approach to studying response shift phenomena, which influence many of the subjective aspects of participation.
The English, Dutch, and Chinese versions of the SRPQ have been proven to be reliable and valid tools for measurement assessing social role participation in individuals with AS. Davis et al. have reported that this tool can also be used to evaluate the complex relationships between symptoms, disability, and participation, along with the personal and environmental contextual factors that influence them.
Currently, in Turkey, there is no valid and reliable tool that simultaneously evaluates the importance, physical difficulty, and satisfaction related to social role participation in individuals with AS. This study aims to translate the SRPQ, into Turkish as it encompasses all dimensions of social role participation, and to evaluate its validity and reliability among Turkish-speaking individuals with AS, thereby providing a culturally appropriate assessment tool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Having severe psychiatric conditions
- Concomitant severe medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Role Participation QuestionnaireValidity and Reliability of the Turkish Version of the Adapted Social Role Participation Questionnaire in Ankylosing Spondylitis | Other | – |
Primary outcome
Reliability of the Turkish Version of the Adapted Social Role Participation Questionnaire (SRPQ) in Ankylosing Spondylitis
Time frame: 2018-2022
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.
Validity of the Turkish Version of the Adapted Social Role Participation Questionnaire (SRPQ) in Ankylosing Spondylitis
Time frame: 2018-2022
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 12216167Jimenez 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.
- Background: PubMed 21791450Davis 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.
- Background: PubMed 12381506Sieper 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.
- Background: PubMed 17013999van 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.
- Background: PubMed 18597401Gignac 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.
- Background: PubMed 20801280Dijkers 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.
- Background: PubMed 26870393van 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.
- Background: PubMed 29151172Zhang 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.
- International classification of functioning, disability and health (ICF) 2001Link provided by the sponsor.
- Measuring participation in people with spondyloarthritis using the social role participation questionnaireLink provided by the sponsor.
- Ankylosing spondylitis: an overviewLink provided by the sponsor.
- Identification of the most common problems by patients with ankylosing spondylitis using the international classification of functioning, disability and healthLink provided by the sponsor.
- Understanding social role participation: what matters to people with arthritis?Link provided by the sponsor.
- Issues in the conceptualization and measurement of participation: an overviewLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Participation, Patient, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the Turkish Version of the Adapted Social Role Participation Questionnaire (SRPQ) in Ankylosing Spondylitis (time frame: 2018-2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06948968, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.