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Rheumatoid ArthritisNCT07054749

Artificial Intelligence Literacy and E-Health Literacy in Rheumatic Diseases

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate digital health competencies in individuals with rheumatic and degenerative joint diseases. Specifically, it assesses e-health literacy and artificial intelligence literacy, which refer to individuals' ability to access, understand, and utilize online health information and AI-based health… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
201 participants
Where
1 siteTurkey (Türkiye)
Study dates
22 Dec 2024to 31 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of adult patients diagnosed with inflammatory rheumatic diseases (RA, AS, PSA), knee osteoarthritis, and age- and gender-matched healthy individuals recruited from a university hospital and the local community in Yozgat, Turkey.

Who may be able to join

  • Age between 18 and 65 years
  • Adequate cognitive function and literacy
  • Ability to provide written informed consent
  • For RA group: Diagnosis of rheumatoid arthritis based on ACR 2010 criteria
  • For AS group: Diagnosis of ankylosing spondylitis based on Modified New York criteria
  • For PSA group: Diagnosis of psoriatic arthritis based on CASPAR criteria
  • For OA group: Clinical and radiological diagnosis of knee osteoarthritis with symptoms ≥6 months
  • For healthy controls: No known chronic diseases or complaints

Who cannot join

  • Cognitive impairment or illiteracy
  • Unwillingness to participate
  • Presence of multiple rheumatic diseases
  • Major psychiatric disorder or neurodegenerative disease
  • Use of assistive digital devices that influence e-health literacy independently

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    Yozgat, Yozgat, 66100

Other trials in Turkey (Türkiye)

About this study

Official title: Artificial Intelligence Literacy and E-Health Literacy in Inflammatory Rheumatic Diseases: A Cross-Sectional Observational Study

This study aims to evaluate digital health competencies in individuals with rheumatic and degenerative joint diseases. Specifically, it assesses e-health literacy and artificial intelligence literacy, which refer to individuals' ability to access, understand, and utilize online health information and AI-based health technologies. Participants include patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, knee osteoarthritis, and healthy volunteers. The study also examines how these competencies are associated with demographic variables, anxiety, depression, and functional status. Findings may contribute to improving digital health strategies for patients with chronic musculoskeletal conditions.

Read the detailed description

Digital technologies and artificial intelligence (AI) are becoming increasingly integrated into healthcare systems. However, the ability of patients to effectively access and use these technologies varies depending on multiple factors such as education level, health status, and psychological well-being. This cross-sectional study aims to measure two key competencies: e-health literacy (the ability to seek, find, understand, and appraise online health information) and artificial intelligence literacy (understanding and engaging with AI-supported health tools).

The study will recruit three groups: individuals with inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), individuals with degenerative joint disease (knee osteoarthritis), and healthy controls. All participants will complete standardized self-report questionnaires, including the E-Health Literacy Scale (eHEALS), the Artificial Intelligence Literacy Scale (AILS), the Beck Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the Health Assessment Questionnaire (HAQ).

The primary aim is to compare digital literacy levels across groups and examine correlations with socio-demographic characteristics and mental health indicators. The results are expected to inform clinical strategies and patient education programs aimed at improving engagement with digital health services, particularly in patients with chronic rheumatic conditions.

Keywords
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Knee Osteoarthritis, Digital Health, e-Health Literacy, Artificial Intelligence Literacy
Medical subject headings
Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07054749
Study groupRoleWhat they receive
Patient groupInclusion criteria for the Rheumatoid arthritis group were: meeting the 2010 American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis , aged 18-65 years, preserved cognitive function, literacy, and willingness to participate. The ankylosing spondylitis group included individuals who met the Modified New York criteria for ankylosing spondylitis and fulfilled the same cognitive, literacy, and age requirements. Similarly, the psoriatic arthritis group consisted of patients meeting the the Classification of Psoriatic Arthritis (CASPAR) criteria classification criteria, aged 18-65, with adequate cognition and literacy, and who consented to participate.
The knee osteoarthritis control groupThe knee osteoarthritis control group included individuals who presented to the same clinic with chronic knee pain (≥6 months), were diagnosed with knee OA based on clinical and radiological findings, and matched the IRD group by age and gender using frequency matching. They also had adequate cognitive and literacy levels and provided consent.
The healthy control groupThe healthy control group was composed of community-dwelling individuals without any diagnosed chronic disease or complaints, matched to the patient group in terms of age and gender, with preserved cognitive function, literacy, and voluntary participation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. E-Health Literacy Scale (eHEALS) - Total Score

    The primary outcome is the total score on the E-Health Literacy Scale (eHEALS), which assesses individuals' ability to seek, find, understand, and evaluate health information from electronic sources. The eHEALS consists of 8 items, each rated on a 5-point Likert scale. Total scores range from 8 to 40, with higher scores indicating greater e-health literacy.

    Measured: At baseline

  2. Artificial Intelligence Literacy Scale (AILS) Total Score

    This outcome measures participants' knowledge, skills, and attitudes related to understanding and using artificial intelligence technologies in healthcare. The Artificial Intelligence Literacy Scale (AILS) includes 12 items scored on a 7-point Likert scale. Total scores range from 12 to 84, with higher scores reflecting greater AI literacy.

    Measured: At baseline

Secondary outcomes (6)

  1. Beck Depression Inventory (BDI) Total Score

    The Beck Depression Inventory (BDI) is used to assess the severity of depressive symptoms. It includes 21 items, each scored on a 0 to 3 scale. Total scores range from 0 to 63, with higher scores indicating more severe depression.

    Measured: At baseline

  2. Beck Anxiety Inventory (BAI) Total Score

    The Beck Anxiety Inventory (BAI) measures the severity of anxiety symptoms. It includes 21 self-reported items, each scored from 0 to 3. Total scores range from 0 to 63, with higher scores reflecting greater anxiety.

    Measured: At baseline

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

    The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is used to evaluate pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items scored on a 5-point Likert scale (0 = none to 4 = extreme). Total scores range from 0 to 96, with higher scores indicating greater symptom severity and functional impairment.

    Measured: At baseline

  4. Disease Activity Score 28 (DAS28) - Total Score

    The Disease Activity Score 28 (DAS28) is used to assess disease activity in patients with rheumatoid arthritis. It incorporates counts of 28 tender and swollen joints, a patient global health assessment, and either erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) as inflammatory markers. Scores range from 0 to 10, with higher scores indicating more active disease.

    Measured: At baseline

  5. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - Total Score

    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is used to assess disease activity in patients with ankylosing spondylitis. It includes six questions related to fatigue, spinal and peripheral joint pain, localized tenderness, and morning stiffness. Each item is scored on a 0 to 10 scale, and the final BASDAI score is the average of the items. Total scores range from 0 to 10, with higher scores indicating greater disease activity and more severe symptoms.

    Measured: At baseline

  6. Disease Activity Index for Psoriatic Arthritis (DAPSA)

    The Disease Activity index for Psoriatic Arthritis (DAPSA) is used to evaluate disease activity in patients with psoriatic arthritis. It is calculated using the sum of the tender joint count (TJC, 68 joints), swollen joint count (SJC, 66 joints), patient global assessment (0-10 scale), patient pain assessment (0-10 scale), and C-reactive protein (CRP, mg/dL). Total scores range from 0 to approximately 150, with higher scores indicating greater disease activity.

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start22 Dec 2024
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054749
Sponsor's protocol ID
2024-GOKAEK-2413_2024.11.20_17
Status last verified
Jul 2025
First submitted
27 Jun 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie the results reported in this article (including text, tables, and figures) will be shared after deidentification. Data will be available upon reasonable request from the corresponding author

Publications

  • Çelebi, C., et al., Artificial intelligence literacy: An adaptation study. Instructional Technology and Lifelong Learning, 2023. 4(2): p. 291-306.

  • Wang, B., P.-L.P. Rau, and T. Yuan, Measuring user competence in using artificial intelligence: validity and reliability of artificial intelligence literacy scale. Behaviour & information technology, 2023. 42(9): p. 1324-1337.

  • TAMER GENCER, Z., Analysis of validity and reliability of Norman and Skinner's e-Health scale literacy for cultural adaptation. Istanbul Universitesi Iletisim Fakultesi Dergisi,

  • Norman CD, Skinner HA. eHealth Literacy: Essential Skills for Consumer Health in a Networked World. J Med Internet Res. 2006 Jun 16;8(2):e9. doi: 10.2196/jmir.8.2.e9.

    PubMed 16867972

  • 49. Ulusoy, M., N.H. Sahin, and H. Erkmen, Turkish version of the Beck Anxiety Inventory: psychometric properties. Journal of cognitive psychotherapy, 1998. 12(2): p. 163.

  • Hisli, N., A reliability and validity study of Beck Depression Inventory in a university student sample). J. Psychol., 1989. 7: p. 3-13.

  • Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.

    PubMed 15639634

  • Schoels M, Aletaha D, Funovits J, Kavanaugh A, Baker D, Smolen JS. Application of the DAREA/DAPSA score for assessment of disease activity in psoriatic arthritis. Ann Rheum Dis. 2010 Aug;69(8):1441-7. doi: 10.1136/ard.2009.122259. Epub 2010 Jun 4.

    PubMed 20525844

  • Akkoc Y, Karatepe AG, Akar S, Kirazli Y, Akkoc N. A Turkish version of the Bath Ankylosing Spondylitis Disease Activity Index: reliability and validity. Rheumatol Int. 2005 May;25(4):280-4. doi: 10.1007/s00296-003-0432-y. Epub 2004 Jan 17.

    PubMed 14730386

  • Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009 Jun;68(6):954-60. doi: 10.1136/ard.2007.084459. Epub 2008 May 19.

    PubMed 18490431

  • Karakilic GD, Balbaloglu O, Gocer S. Digital and artificial intelligence literacy in inflammatory rheumatic and degenerative joint diseases. Adv Med Sci. 2026 Mar;71(1):114-121. doi: 10.1016/j.advms.2026.03.004. Epub 2026 Mar 20.

    PubMed 41866024

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

E-Health Literacy Scale (eHEALS) - Total Score (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07054749, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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