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

May 27, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Izmir, Turkey
        • Dokuz Eylul University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Siirt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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