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NCT Number: NCT06230952

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

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dokuz Eylül University

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BASDAI and BASFI reliability

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Age

    Time frame: Baseline

    Age in years

  2. Disease duration

    Time frame: Baseline

    Disease duration in years

  3. Medications

    Time frame: Baseline

    The medications used by patients will be recorded

  4. weight

    Time frame: Baseline

    weight (kg)

  5. height

    Time frame: Baseline

    height (m)

  6. Education

    Time frame: Baseline

    Education level of patients will be recorded

Sponsors and collaborators

Lead sponsor

Siirt University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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