Axial SpondyloarthritisNCT06230952
Reliability of BASDAI and BASFI Applied by Tele-Assessment Method in Axial SpA Spondyloarthritis
An observational study of Axial Spondyloarthritis, run by Siirt University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the reliability of BASDAI and BASFI questionnaires applied via tele-assessment in axial spondyloarthritis patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- BASDAI and BASFI reliability
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2024to 27 May 2024
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: It was planned to include at least 100 axial SpA patients in the study.
Who may be able to join
- Being diagnosed with Axial spondyloarthritis according to the Assessment in SpondyloArthritis international Society (ASAS) criteria
- Volunteering to participate in the study
- Being between the ages of 20-60
Who cannot join
- Having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis
- Pregnancy
- The patient wishes to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) Applied by Tele-Assessment Method in Patients With Axial Spondyloarthritis
The goal of this observational study is to investigate the reliability of BASDAI and BASFI questionnaires applied via tele-assessment in axial spondyloarthritis patients.
Read the detailed description
Telehealth is the provision of healthcare services and clinical practices remotely through information and communication technologies. In recent years, the use of telehealth applications has increased worldwide. Telehealth is an umbrella term that covers practices such as telemedicine, telerehabilitation, and tele-assessment. Tele-assessment has gained importance in terms of monitoring patients with chronic diseases. Although BASDAI and BASFI have been shown to be valid and reliable in AS patients, there is no study in the literature examining the reliability of BASDAI and BASFI applied via tele-assessment. The aim of our study is to investigate the reliability of BASDAI and BASFI questionnaires administered via tele-assessment in axial SpA patients.
- Conditions
- Axial Spondyloarthritis
- Being tested
- BASDAI and BASFI reliability
- Keywords
- axial spondyloarthritis, BASDAI, BASFI, self assessment, tele-assessment, reliability
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASDAI and BASFI reliabilityOther
The study will be carried out on volunteer patients who are diagnosed with axial spondyloarthritis and are followed up in the outpatient clinic of Dokuz Eylül University, Department of Internal Medicine, Rheumatology and Immunology Department, and who meet the inclusion criteria. Patients who volunteer to participate in the study will be contacted by phone and BASDAI and BASFI questionaires will be administered.
| Study group | Role | What they receive |
|---|---|---|
| axial spondyloarthritis patients | patients diagnosed with axial spondyloarthritis Receives: Other: BASDAI and BASFI reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a reliable and sensitive index developed to evaluate the activity and progression of the disease. The BASDAI is a 6-item composite index that measures fatigue, neck, back, hip pain, peripheral joint pain/swelling, and morning stifness. The final BASDAI score ranges from 0 to 10, and higher scores represent higher disease activity.
Measured: Baseline and after 24 hours after baseline assessment
Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is an easy-to-apply, sensitive and reliable self-report questionnaire developed to evaluate physical function in AS patients. It consists of a total of 10 items, eight assessing functionality and two assessing the patient's ability to cope with daily life. The BASFI Score is the avarage of the 10 items and ranges between 0 and 10, with higher scores indicating greater functional limitation.
Measured: Baseline and after 24 hours after baseline assessment
Secondary outcomes (6)
Age
Age in years
Measured: Baseline
Disease duration
Disease duration in years
Measured: Baseline
Medications
The medications used by patients will be recorded
Measured: Baseline
weight
weight (kg)
Measured: Baseline
height
height (m)
Measured: Baseline
Education
Education level of patients will be recorded
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start8 Feb 2024
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ACAR, Siirt University
- Investigators
- Yasemin ACAR, PhD, Study director, Siirt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230952
- Sponsor's protocol ID
- 2023/39-19
- Status last verified
- May 2024
- First submitted
- 16 Jan 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acar Y, Ilcin N, Sari I. Reliability of the Bath Ankylosing Spondylitis Disease Activity Index and the Bath Ankylosing Spondylitis Functional Index administered via tele-assessment in patients with axial spondyloarthritis. Physiother Theory Pract. 2025 Dec;41(12):2585-2594. doi: 10.1080/09593985.2025.2536319. Epub 2025 Jul 21.
PubMed 40686331
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI) Applied by Tele-Assessment Method in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06230952
- Acronym / sponsor ID
- 2023/39-19
- Conditions
- Axial Spondyloarthritis
- Keywords
- axial spondyloarthritis, BASDAI, BASFI, self assessment, tele-assessment, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 30 Jan 2024 (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 goal of this observational study is to investigate the reliability of BASDAI and BASFI questionnaires applied via tele-assessment in axial spondyloarthritis patients.
Detailed description
Telehealth is the provision of healthcare services and clinical practices remotely through information and communication technologies. In recent years, the use of telehealth applications has increased worldwide. Telehealth is an umbrella term that covers practices such as telemedicine, telerehabilitation, and tele-assessment. Tele-assessment has gained importance in terms of monitoring patients with chronic diseases. Although BASDAI and BASFI have been shown to be valid and reliable in AS patients, there is no study in the literature examining the reliability of BASDAI and BASFI applied via tele-assessment. The aim of our study is to investigate the reliability of BASDAI and BASFI questionnaires administered via tele-assessment in axial SpA patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| axial spondyloarthritis patients | – | Other: BASDAI and BASFI reliabilitypatients diagnosed with axial spondyloarthritis |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It was planned to include at least 100 axial SpA patients in the study.
Key inclusion criteria (3 listed)
- Being diagnosed with Axial spondyloarthritis according to the Assessment in SpondyloArthritis international Society (ASAS) criteria
- Volunteering to participate in the study
- Being between the ages of 20-60
Key exclusion criteria (3 listed)
- Having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis
- Pregnancy
- The patient wishes to withdraw from the study
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 |
|---|---|---|
| BASDAI and BASFI reliabilityThe study will be carried out on volunteer patients who are diagnosed with axial spondyloarthritis and are followed up in the outpatient clinic of Dokuz Eylül University, Department of Internal Medicine, Rheumatology and Immunology Department, and who meet the inclusion criteria. Patients who volunteer to participate in the study will be contacted by phone and BASDAI and BASFI questionaires will be administered. | Other | axial spondyloarthritis patients |
Primary outcome
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline and after 24 hours after baseline assessment
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a reliable and sensitive index developed to evaluate the activity and progression of the disease. The BASDAI is a 6-item composite index that measures fatigue, neck, back, hip pain, peripheral joint pain/swelling, and morning stifness. The final BASDAI score ranges from 0 to 10, and higher scores represent higher disease activity.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline and after 24 hours after baseline assessment
BASFI is an easy-to-apply, sensitive and reliable self-report questionnaire developed to evaluate physical function in AS patients. It consists of a total of 10 items, eight assessing functionality and two assessing the patient's ability to cope with daily life. The BASFI Score is the avarage of the 10 items and ranges between 0 and 10, with higher scores indicating greater functional limitation.
6 secondary outcomes
Age
Time frame: Baseline
Disease duration
Time frame: Baseline
Medications
Time frame: Baseline
weight
Time frame: Baseline
height
Time frame: Baseline
Education
Time frame: Baseline
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 29 May 2024.
- Derived from this study: PubMed 40686331Acar Y, Ilcin N, Sari I. Reliability of the Bath Ankylosing Spondylitis Disease Activity Index and the Bath Ankylosing Spondylitis Functional Index administered via tele-assessment in patients with axial spondyloarthritis. Physiother Theory Pract. 2025 Dec;41(12):2585-2594. doi: 10.1080/09593985.2025.2536319. Epub 2025 Jul 21.
- Individual participant dataSharing planned: No
Related trials for Axial Spondyloarthritis
Not yet recruitingObservational study
SLAMF1 Gene Expression in Ankylosing Spondylitis
Ankylosing Spondylitis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Recruiting
RENEW Intervention for Axial Spondyloarthritis
Axial Spondyloarthritis
RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
Not yet recruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
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.
Yasemin ACAR, PhD study director
Siirt University
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 Axial Spondyloarthritis, run by Siirt 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 3 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 29 May 2024. 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?
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (time frame: Baseline and after 24 hours after baseline assessment). 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 NCT06230952, which also lists 1 linked publication.
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 29 May 2024.