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

February 8, 2024 updated by: Yasemin ACAR, Siirt University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

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
Intervention / Treatment
axial spondyloarthritis patients
patients diagnosed with axial spondyloarthritis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 24 hours after baseline assessment
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.
Baseline and after 24 hours after baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Baseline
Age in years
Baseline
Disease duration
Time Frame: Baseline
Disease duration in years
Baseline
Medications
Time Frame: Baseline
The medications used by patients will be recorded
Baseline
weight
Time Frame: Baseline
weight (kg)
Baseline
height
Time Frame: Baseline
height (m)
Baseline
Education
Time Frame: Baseline
Education level of patients will be recorded
Baseline

Collaborators and Investigators

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

Sponsor

Siirt University

Investigators

  • Study Director: Yasemin ACAR, PhD, Siirt University

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)

February 8, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/39-19

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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