Artificial Intelligence Literacy and E-Health Literacy in Rheumatic Diseases

July 10, 2025 updated by: Gulseren Demir Karakilic

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.

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.

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.

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.
201

Contacts and Locations

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

Study Locations

  • Turkey
      • Yozgat, Turkey, 66100
        • Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

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

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.
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.

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
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.
At baseline
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.
At baseline

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
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.
At baseline
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.
At baseline
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.
At baseline
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.
At baseline
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.
At baseline
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.
At 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.
Gulseren Demir Karakilic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
December 22, 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 31, 2025

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 31, 2025

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).
June 27, 2025

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.
June 27, 2025

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.
July 8, 2025

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.
July 14, 2025

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.
July 10, 2025

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.
July 1, 2025

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.
  • 2024-GOKAEK-2413_2024.11.20_17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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