Work Productivity and Social Activities In Patients With Ankylosing Spondylitis

February 7, 2021 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Derya Bugdayci, Assoc Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One day
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
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form Health Survey 36 (SF-36)
Time Frame: One day
used to evaluate the quality of life
One day
Hospital Anxiety and Depression Scale (HADS)
Time Frame: One day
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
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: One day
the assessment of disease activity in patients with ankylosing spondylitis
One day
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: One day
the assessment of functional status in patients with ankylosing spondylitis
One day
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: One day
the assessment of the level of spinal mobility in patients with ankylosing spondylitis
One day
Ankylosing Spondylitis Quality of Life (ASQoL)
Time Frame: One day
used to evaluate the quality of life in patients with ankylosing spondylitis
One day
Visual Analogue Scale (VAS)
Time Frame: One day
used to evaluate the pain
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: Ömer Faruk Bucak, MD, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

April 15, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 7, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 7, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPRMTRH-ASWP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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