NCT06230952

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

January 16, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 8, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

January 16, 2024

Last Update Submit

May 27, 2024

Conditions

Keywords

axial spondyloarthritisBASDAIBASFIself assessmenttele-assessmentreliability

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and after 24 hours after baseline assessment

Secondary Outcomes (6)

  • Age

    Baseline

  • Disease duration

    Baseline

  • Medications

    Baseline

  • weight

    Baseline

  • height

    Baseline

  • +1 more secondary outcomes

Study Arms (1)

axial spondyloarthritis patients

patients diagnosed with axial spondyloarthritis

Other: BASDAI and BASFI reliability

Interventions

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.

axial spondyloarthritis patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

It was planned to include at least 100 axial SpA patients in the study.

You may qualify if:

  • 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

You may not qualify if:

  • Having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis
  • Pregnancy
  • The patient wishes to withdraw from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Yasemin ACAR, PhD

    Siirt University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 30, 2024

Study Start

February 8, 2024

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations