Ankylosing SpondylitisNCT04749537
Work Productivity and Social Activities In Patients With Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Work Productivity, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Work Productivity
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 15 Dec 2020
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients with AS diagnosis between the ages of 18-65
- Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Ankylosing Spondylitis, Work Productivity
- Keywords
- Spondylitis, Ankylosing, Quality of Life, Employment
- Medical subject headings
- Spondylitis, Ankylosing, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis | 100 patients who were diagnosed with AS between the ages of 18-65 | |
| Healthy Volunteers | 100 healthy volunteers compatible with age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: One day
Secondary outcomes (7)
Short Form Health Survey 36 (SF-36)
used to evaluate the quality of life
Measured: One day
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.
Measured: One day
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
the assessment of disease activity in patients with ankylosing spondylitis
Measured: One day
Bath Ankylosing Spondylitis Functional Index (BASFI)
the assessment of functional status in patients with ankylosing spondylitis
Measured: One day
Bath Ankylosing Spondylitis Metrology Index (BASMI)
the assessment of the level of spinal mobility in patients with ankylosing spondylitis
Measured: One day
Ankylosing Spondylitis Quality of Life (ASQoL)
used to evaluate the quality of life in patients with ankylosing spondylitis
Measured: One day
Visual Analogue Scale (VAS)
used to evaluate the pain
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start15 Apr 2019
- Primary completion15 Apr 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ömer Faruk Bucak, MD, Principal investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749537
- Sponsor's protocol ID
- IstPRMTRH-ASWP
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30385702Goh 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.
PubMed 31576680Sag 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.
PubMed 29504521van 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.
PubMed 29155961Oude 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.
PubMed 27182067van 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.
PubMed 27059161Cakar 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.
PubMed 19685294Maksymowych 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.
PubMed 19955052Deodhar 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.
PubMed 27390130
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04749537
- Acronym / sponsor ID
- IstPRMTRH-ASWP
- Conditions
- Ankylosing Spondylitis, Work Productivity
- Keywords
- Spondylitis, Ankylosing, Quality of Life, Employment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 11 Feb 2021 (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.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis | – | –100 patients who were diagnosed with AS between the ages of 18-65 |
| Healthy Volunteers | – | –100 healthy volunteers compatible with age. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with AS diagnosis between the ages of 18-65
- Healthy volunteer individuals between the ages of 18-65 without known musculoskeletal disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
Time frame: One day
WPAI: GH measures health impact and symptom severity impact on work productivity and leave time effectiveness
Social Role Participation Questionnaire (SRPQ)
Time frame: 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
7 secondary outcomes
Short Form Health Survey 36 (SF-36)
Time frame: One day
Hospital Anxiety and Depression Scale (HADS)
Time frame: One day
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: One day
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: One day
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: One day
Ankylosing Spondylitis Quality of Life (ASQoL)
Time frame: One day
Visual Analogue Scale (VAS)
Time frame: One day
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 11 Feb 2021.
- Background: PubMed 30385702Macfarlane 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.
- Background: PubMed 31576680Goh 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.
- Background: PubMed 29504521Sag 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.
- Background: PubMed 29155961van 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.
- Background: PubMed 27182067Oude 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.
- Background: PubMed 27059161van 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.
- Background: PubMed 19685294Cakar 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.
- Background: PubMed 19955052Maksymowych 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.
- Background: PubMed 27390130Deodhar 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.
- 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.
Ömer Faruk Bucak, MD principal investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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 Work Productivity, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 2 inclusion and 7 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 11 Feb 2021. 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?
Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH) (time frame: One day). 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 NCT04749537, which also lists 9 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 11 Feb 2021.