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NCT Number: NCT07054749

Artificial Intelligence Literacy and E-Health Literacy in Rheumatic Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: At baseline

    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.

  2. Artificial Intelligence Literacy Scale (AILS) Total Score

    Time frame: At baseline

    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.

Secondary outcomes

  1. Beck Depression Inventory (BDI) Total Score

    Time frame: At baseline

    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.

  2. Beck Anxiety Inventory (BAI) Total Score

    Time frame: At baseline

    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.

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

    Time frame: At baseline

    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.

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

    Time frame: At baseline

    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.

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

    Time frame: At baseline

    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.

  6. Disease Activity Index for Psoriatic Arthritis (DAPSA)

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

Gulseren Demir Karakilic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Jul 14, 2025

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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