NCT07054749

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 27, 2025

Last Update Submit

July 10, 2025

Conditions

Keywords

Rheumatoid ArthritisAnkylosing SpondylitisPsoriatic ArthritisKnee OsteoarthritisDigital Healthe-Health LiteracyArtificial Intelligence Literacy

Outcome Measures

Primary Outcomes (2)

  • 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.

    At baseline

  • 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.

    At baseline

Secondary Outcomes (6)

  • Beck Depression Inventory (BDI) Total Score

    At baseline

  • Beck Anxiety Inventory (BAI) Total Score

    At baseline

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

    At baseline

  • Disease Activity Score 28 (DAS28) - Total Score

    At baseline

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

    At baseline

  • +1 more secondary outcomes

Study Arms (3)

Patient group

Inclusion 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 group

The 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 group

The 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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (10)

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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,

    BACKGROUND
  • 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.

    PMID: 16867972BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 15639634BACKGROUND
  • 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.

    PMID: 20525844BACKGROUND
  • 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.

    PMID: 14730386BACKGROUND
  • 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.

    PMID: 18490431BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylitis, AnkylosingArthritis, PsoriaticOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesOsteoarthritis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

December 22, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
IPD and supporting documents will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years.
Access Criteria
"Qualified researchers with a methodologically sound proposal will be able to access de-identified individual participant data and supporting documents upon reasonable request to the corresponding author. Proposals will be evaluated for scientific merit and data will be shared through secure data transfer methods.
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