Reliability of BASDAI and BASFI Applied by Tele-Assessment Method in Axial SpA Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06230952
• Other study ID #: 2023/39-19
• Status: Completed
• Start date: February 8, 2024
• Est. completion date: May 27, 2024

Study information

• Verified date: May 2024
• Source: Siirt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 27, 2024
• Est. primary completion date: May 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis

• Pregnancy

• The patient wishes to withdraw from the study

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Other:
• BASDAI and BASFI reliability
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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylül University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Siirt University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Age	Age in years	Baseline
Secondary	Disease duration	Disease duration in years	Baseline
Secondary	Medications	The medications used by patients will be recorded	Baseline
Secondary	weight	weight (kg)	Baseline
Secondary	height	height (m)	Baseline
Secondary	Education	Education level of patients will be recorded	Baseline