Rheumatoid ArthritisNCT06993935
Health Literacy, Rational Drug Use, and Cyberchondria in Rheumatic Diseases
An observational study of Rheumatoid Arthritis and Health Literacy, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aimed to evaluate rational drug use (RDU), health literacy (HL), and cyberchondria levels among individuals diagnosed with inflammatory rheumatic diseases, and to investigate the factors associated with these three key health-related variables. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Health Literacy, Rational Drug Use
- How many people
- 228 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2026to 24 Jul 2026
- How long will I take part?
- 1 Day
- 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: Adults aged 18 to 65 years, including patients diagnosed with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or knee osteoarthritis, as well as healthy controls matched for age and gender. All participants had sufficient cognitive abilities, were literate, and consented to participate.
Who may be able to join
- Obtained approval from the local ethics committee. Provided informed consent to participate. Aged 18 to 65 years. Possessed intact cognitive functions. Literate. For the Rheumatoid Arthritis (RA) group: Met the 2010 ACR criteria for Rheumatoid Arthritis.
- For the Ankylosing Spondylitis (AS) group: Met the Modified New York criteria. For the Psoriatic Arthritis (PsA) group: Met the Classification of Psoriatic Arthritis (CASPAR) criteria.
- For the Knee Osteoarthritis (KOA) control group:
- Visited the Physical Medicine and Rehabilitation clinic due to knee pain lasting six months or longer.
- Diagnosed with knee osteoarthritis. Matched the patient group in terms of age and gender. Demonstrated adequate cognitive abilities. Possessed literacy skills.
- For the Healthy control group:
- Same age and gender as the patient group. Had good cognitive functions. Literate. Had no disease or complaints.
Who cannot join
- Under the age of 18 or over the age of 65. Any condition that could impair communication. Refusal to participate in the study. Not possessing digital devices such as a smartphone or computer, or lacking internet access.
- Illiterate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Assessment of Health Literacy, Rational Drug Use, and Cyberchondria Levels in Individuals With Inflammatory Rheumatic Diseases
Purpose: This study aimed to evaluate rational drug use (RDU), health literacy (HL), and cyberchondria levels among individuals diagnosed with inflammatory rheumatic diseases, and to investigate the factors associated with these three key health-related variables.
Methods: This research was designed as a cross-sectional study and conducted between December 2024 and May 2025. The study enrolled three cohorts: a case cohort comprising patients diagnosed with rheumatic disease as patient group (group 1); a disease control cohort of knee osteoarthritis (group 2), and a reference control cohort of age- and sex-matched healthy participants (group 3). Disease Activity Score 28 (DAS28) was administered to patients with rheumatoid arthritis; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was administered to patients with ankylosing spondylitis; Psoriatic Arthritis Disease Activity Index (DAPSA) was administered to patients with psoriatic arthritis; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) was administered to patients with knee osteoarthritis; and Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Turkey Health Literacy Scale-32 (THLS-32), Rational Drug Use Scale (RDUS), and Cyberchondria Severity Scale (CSS) were administered to all participants.
Read more
Results: The study sample consisted of 228 participants, with 76 individuals assigned to each of the three groups. Mean age, and gender distribution were similar in all three groups. Statistically significant variations were observed across the three groups regarding THLS-32, RDUS, and CSS scores (p < 0.001). Group 1 had the highest HL and RDUS scores, and moderate CSS scores. In contrast, Group 2 showed the lowest HL and RDUS scores, while Group 3 demonstrated the highest CSS scores. HL was positively correlated with RDU (r = 0.552, p < 0.001), and moderately negatively correlated with cyberchondria (r = -0.448, p < 0.001). These results indicate that higher HL is associated with more rational medication behavior and reduced susceptibility to online health-related anxiety. (p< 0.001).
Conclusions: To our knowledge, this is the first study to simultaneously investigate RDU and CSS in individuals diagnosed with RA, AS, and knee osteoarthritis. Our findings demonstrate that higher levels of HL are significantly associated with more appropriate medication behaviors and lower levels of internet-related health anxiety. These results emphasize the multidimensional role of HL, not only in promoting RDU but also in mitigating maladaptive digital health information-seeking patterns.
Read the detailed description
Patient And Methods Study Design This prospective cross-sectional investigation was conducted from December 2024 to May 2025, involving both patient and control cohorts. Prior to enrollment, all participants provided written and verbal informed consent following a detailed explanation of the study objectives. The research protocol received full ethical approval from the Human Research Ethics Committee (2024-GOKAEK-2411_2024.10.16_188), ensuring adherence to international ethical guidelines. Patient enrollment start date: 22/12/2024, and ClinicalTrials.gov registration ID: NCT06348017.
Patients The study was commenced after obtaining the approval of the local ethics committee and the informed consent of the participants. Patients who applied to the University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, met the 2010 ACR criteria for Rheumatoid Arthritis, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the RA group; those who met the Modified New York criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the AS group; and those who met the Classification of Psoriatic Arthritis (CASPAR criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the PSA group. After completing the surveys of patients with patient group, the gender and age distribution of the patient group was determined. The patient control group consisted of individuals who visited the Physical Medicine and Rehabilitation clinic of the University Faculty of Medicine due to knee pain lasting six months or longer, were diagnosed with knee osteoarthritis, matched the patient group in terms of age and gender, demonstrated adequate cognitive abilities, possessed literacy skills, and agreed to take part in the study. The control group included healthy individuals who were of the same age and gender to the patient group, had good cognitive functions, were literate, had no disease or complaints, and agreed to take part in the study.
The sociodemographic questionnaire, which was the data collection tool, was administered face-to-face to individuals at the Physical Medicine and Rehabilitation clinic along with several assessment scales: the Disease Activity Score 28 (DAS28), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Disease Activity Index for Psoriatic Arthritis (DAPSA), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Beck Depression Inventory (BDI), and the Beck Anxiety Inventory (BAI), as well as the Turkey Health Literacy Scale-32 (THLS-32), the Rational Drug Use Scale (RDUS), and the Cyberchondria Severity Scale (CSS).
DAS28: In patients with RA, disease activity is assessed using the DAS28 scale. This method is a widely used tool to determine disease activity in RA. The evaluation involves assessing 28 joints for tenderness and swelling. The patient's global pain assessment score, along with C-reactive protein (CRP) levels or erythrocyte sedimentation rate (ESR), is entered into a computer program to calculate the DAS28 score. A total score >5.1 indicates high disease activity, a score between 3.2-5.1 indicates moderate disease activity, a score <3.2 indicates low disease activity, and a score <2.6 is considered remission [29].
BASDAI: The BASDAI is used to evaluate disease activity in patients with AS. As the BASDAI score increases, the level of disability associated with the disease also rises. A BASDAI score ≥4 indicates active disease. The Turkish validity and reliability study of the BASDAI was conducted in 2005 [30].
DAPSA: Disease activity in patients with PSA is assessed using the DAPSA score. This method is based on the evaluation of 68 joints for tenderness and 66 joints for swelling. The number of tender and swollen joints, the pain assessment score via the Visual Analog Scale (VAS), the physician's global assessment, and CRP values are summed to calculate the DAPSA score. A score >28 indicates high disease activity, a score between 15-28 indicates moderate disease activity, a score between 5-14 indicates low disease activity, and a score <4 is considered remission [31].
WOMAC: is a tool commonly used to assess the level of functional impairment in patients with knee osteoarthritis. It includes 24 items divided into three domains: pain, stiffness, and physical function. Each item is rated on a scale from 0 (none) to 4 (extreme), with higher total scores reflecting greater severity of symptoms and functional limitations. The Turkish adaptation of the WOMAC was validated by Tüzün et al. [32].
BDI: is developed by Beck and colleagues in 1961, is intended to evaluate the typical signs and symptoms associated with depression. This instrument is a self-administered questionnaire comprising 21 items and usually requires around 10 minutes to complete. The Turkish version of the inventory was adapted and validated by Hisli and colleagues [33].
BAI: is developed by Aaron T. Beck, is an internationally validated tool for assessing anxiety levels. It consists of 21 items. The Turkish adaptation and validation of the inventory were performed by Ulusoy and colleagues [34].
THLS-32: Developed and validated by Okyay and colleagues [35], the THLS-32 measures HL levels. It has two sub-groups: treatment service score and disease prevention score, but there is no separate cut-off value determined for these sub-scales; the higher the score, the higher the literacy. Scores range from 0 to 50, where 0 indicates the lowest and 50 the highest level of HL. HL levels are categorized as follows: 0-25 points indicate "inadequate" HL, >25-33 points indicate "problematic/limited," >33-42 points indicate "adequate," and >42-50 points indicate "excellent" HL.
RDUS: Developed by Demirtaş and colleagues, this scale has undergone a Turkish validity and reliability study [36]. It consists of 21 items scored on a 3-point Likert scale. Responses are scored as "correct answer = 2 points," "I don't know = 1 point," and "wrong answer = 0 points." Total scores range from 0 to 42, with higher scores indicating better levels of RDU. A cutoff score of 34 and above is interpreted as "good RDU." The Cronbach's alpha coefficient for the scale is 0.78.
CSS: Adapted into Turkish by Uzun and Zencir [37], this scale comprises 33 items rated on a 5-point Likert scale, ranging from "Never" to "Always." The scale has five subdimensions: compulsion, excessive concern, excessive searching, reassurance seeking, and distrust of medical professionals. Compulsion, excessive concern, and excessive searching subscales range from 8 to 40 points, reassurance seeking ranges from 6 to 30 points, and distrust of medical professionals ranges from 3 to 15 points. The total score ranges from 33 to 165, with higher scores indicating higher levels of cyberchondria. The overall Cronbach's alpha coefficient of the scale is 0.94.
Statistical analysis Sample analysis was performed using the Openepi application https://www.openepi.com/SampleSize/SSPropor.htm). Based on the study by Kalmaz et al., it was determined that at least 75 participants should be included in each group for a margin of error of 0.05, an effect size of 0.465, and 95% power [28]. Data analysis was conducted using SPSS version 25.0 (SPSS Inc., Armonk, NY). The Kolmogorov-Smirnov test was applied to assess the normality of continuous variables. Categorical data were evaluated with Pearson's Chi-Square Test or Fisher's Exact Test depending on the expected frequencies. For continuous variables, group differences were analyzed using the Student's T-Test or One-Way Analysis of Variance (ANOVA). When multiple group comparisons were necessary, post-hoc analyses were performed using Tukey's or Games-Howell tests. Spearman's correlation coefficients were calculated to explore relationships between variables and disease activity or scale scores, including DAS28, BASDAI, DAPSA, WOMAC, BDI, BAI, THLS-32, RDUS, and CSS within the patient cohort.
- Conditions
- Rheumatoid Arthritis, Health Literacy, Rational Drug Use, Cyberchondria, Chronic Disease, Inflammatory Arthritis
- Keywords
- Rheumatic diseases, Knee osteoarthritis, Health literacy, Rational drug use, Cyberchondria
- Medical subject headings
- Arthritis, Rheumatoid, Chronic Disease, Arthritis, Rheumatic Diseases, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients who applied to the University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, met the 2010 ACR criteria for Rheumatoid Arthritis, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the RA group; those who met the Modified New York criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the AS group; and those who met the Classification of Psoriatic Arthritis (CASPAR criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the PSA group | |
| Control patient group | After completing the surveys of patients with patient group, the gender and age distribution of the patient group was determined. The patient control group consisted of individuals who visited the Physical Medicine and Rehabilitation clinic of the University Faculty of Medicine due to knee pain lasting six months or longer, were diagnosed with knee osteoarthritis, matched the patient group in terms of age and gender, demonstrated adequate cognitive abilities, possessed literacy skills, and agreed to take part in the study. | |
| control group | The control group included healthy individuals who were of the same age and gender to the patient group, had good cognitive functions, were literate, had no disease or complaints, and agreed to take part in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkey Health Literacy Scale-32 (THLS-32)
Developed and validated by Okyay and colleagues, the THLS-32 measures HL levels. It has two sub-groups: treatment service score and disease prevention score, but there is no separate cut-off value determined for these sub-scales; the higher the score, the higher the literacy. Scores range from 0 to 50, where 0 indicates the lowest and 50 the highest level of HL. HL levels are categorized as follows: 0-25 points indicate "inadequate" HL, >25-33 points indicate "problematic/limited," >33-42 points indicate "adequate," and >42-50 points indicate "excellent" HL.
Measured: At enrollment
Rational Drug Use Scale (RDUS),
Developed by Demirtaş and colleagues, this scale has undergone a Turkish validity and reliability study. It consists of 21 items scored on a 3-point Likert scale. Responses are scored as "correct answer = 2 points," "I don't know = 1 point," and "wrong answer = 0 points." Total scores range from 0 to 42, with higher scores indicating better levels of RDU. A cutoff score of 34 and above is interpreted as "good RDU." The Cronbach's alpha coefficient for the scale is 0.78.
Measured: At enrollment
Cyberchondria Severity Scale (CSS)
Adapted into Turkish by Uzun and Zencir, this scale comprises 33 items rated on a 5-point Likert scale, ranging from "Never" to "Always." The scale has five subdimensions: compulsion, excessive concern, excessive searching, reassurance seeking, and distrust of medical professionals. Compulsion, excessive concern, and excessive searching subscales range from 8 to 40 points, reassurance seeking ranges from 6 to 30 points, and distrust of medical professionals ranges from 3 to 15 points. The total score ranges from 33 to 165, with higher scores indicating higher levels of cyberchondria. The overall Cronbach's alpha coefficient of the scale is 0.94.
Measured: At enrollment
the Disease Activity Score 28 (DAS28)
In patients with RA, disease activity is assessed using the DAS28 scale. This method is a widely used tool to determine disease activity in RA. The evaluation involves assessing 28 joints for tenderness and swelling. The patient's global pain assessment score, along with C-reactive protein (CRP) levels or erythrocyte sedimentation rate (ESR), is entered into a computer program to calculate the DAS28 score. A total score >5.1 indicates high disease activity, a score between 3.2-5.1 indicates moderate disease activity, a score <3.2 indicates low disease activity, and a score <2.6 is considered remission.
Measured: At enrollment
the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
The BASDAI is used to evaluate disease activity in patients with AS. As the BASDAI score increases, the level of disability associated with the disease also rises. A BASDAI score ≥4 indicates active disease. The Turkish validity and reliability study of the BASDAI was conducted in 2005.
Measured: At enrollment
the Disease Activity Index for Psoriatic Arthritis (DAPSA)
Disease activity in patients with PSA is assessed using the DAPSA score. This method is based on the evaluation of 68 joints for tenderness and 66 joints for swelling. The number of tender and swollen joints, the pain assessment score via the Visual Analog Scale (VAS), the physician's global assessment, and CRP values are summed to calculate the DAPSA score. A score >28 indicates high disease activity, a score between 15-28 indicates moderate disease activity, a score between 5-14 indicates low disease activity, and a score <4 is considered remission.
Measured: At enrollment
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC),
is a tool commonly used to assess the level of functional impairment in patients with knee osteoarthritis. It includes 24 items divided into three domains: pain, stiffness, and physical function. Each item is rated on a scale from 0 (none) to 4 (extreme), with higher total scores reflecting greater severity of symptoms and functional limitations. The Turkish adaptation of the WOMAC was validated by Tüzün et al.
Measured: At enrollment
the Beck Depression Inventory (BDI),
BDI: is developed by Beck and colleagues in 1961, is intended to evaluate the typical signs and symptoms associated with depression. This instrument is a self-administered questionnaire comprising 21 items and usually requires around 10 minutes to complete. The Turkish version of the inventory was adapted and validated by Hisli and colleagues.
Measured: At enrollment
the Beck Anxiety Inventory (BAI),
is developed by Aaron T. Beck, is an internationally validated tool for assessing anxiety levels. It consists of 21 items. The Turkish adaptation and validation of the inventory were performed by Ulusoy and colleagues.
Measured: At enrollment
Visual Analog Scale (VAS)
For the Evaluation of Pain. For this evaluation, the patient is asked to mark their pain and fatigue severity on a horizontal 10-cm line with the number 0 on one end representing "no pain or no fatigue" and the number 10 on the other end indicating "very severe pain or very severe fatigue."
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start6 Jan 2026
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulseren Demir Karakilic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulseren Demir Karakilic, Bozok University
- Investigators
- Gülseren Demir Karakılıç, Asst Prof, Principal investigator, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993935
- Sponsor's protocol ID
- 2024-GOKAEK-2411_2024.10.16_18
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Health Literacy, Rational Drug Use, and Cyberchondria Levels in Individuals With Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT06993935
- Acronym / sponsor ID
- 2024-GOKAEK-2411_2024.10.16_18
- Conditions
- Rheumatoid Arthritis, Health Literacy, Rational Drug Use, Cyberchondria, Chronic Disease, Inflammatory Arthritis
- Keywords
- Rheumatic diseases, Knee osteoarthritis, Health literacy, Rational drug use, Cyberchondria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Gulseren Demir KarakilicUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This study aimed to evaluate rational drug use (RDU), health literacy (HL), and cyberchondria levels among individuals diagnosed with inflammatory rheumatic diseases, and to investigate the factors associated with these three key health-related variables.
Methods: This research was designed as a cross-sectional study and conducted between December 2024 and May 2025. The study enrolled three cohorts: a case cohort comprising patients diagnosed with rheumatic disease as patient group (group 1); a disease control cohort of knee osteoarthritis (group 2), and a reference control cohort of age- and sex-matched healthy participants (group 3). Disease Activity Score 28 (DAS28) was administered to patients with rheumatoid arthritis; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was administered to patients with ankylosing spondylitis; Psoriatic Arthritis Disease Activity Index (DAPSA) was administered to patients with psoriatic arthritis; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) was administered to patients with knee osteoarthritis; and Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Turkey Health Literacy Scale-32 (THLS-32), Rational Drug Use Scale (RDUS), and Cyberchondria Severity Scale (CSS) were administered to all participants.
Results: The study sample consisted of 228 participants, with 76 individuals assigned to each of the three groups. Mean age, and gender distribution were similar in all three groups. Statistically significant variations were observed across the three groups regarding THLS-32, RDUS, and CSS scores (p < 0.001). Group 1 had the highest HL and RDUS scores, and moderate CSS scores. In contrast, Group 2 showed the lowest HL and RDUS scores, while Group 3 demonstrated the highest CSS scores. HL was positively correlated with RDU (r = 0.552, p < 0.001), and moderately negatively correlated with cyberchondria (r = -0.448, p < 0.001). These results indicate that higher HL is associated with more rational medication behavior and reduced susceptibility to online health-related anxiety. (p< 0.001).
Conclusions: To our knowledge, this is the first study to simultaneously investigate RDU and CSS in individuals diagnosed with RA, AS, and knee osteoarthritis. Our findings demonstrate that higher levels of HL are significantly associated with more appropriate medication behaviors and lower levels of internet-related health anxiety. These results emphasize the multidimensional role of HL, not only in promoting RDU but also in mitigating maladaptive digital health information-seeking patterns.
Detailed description
Patient And Methods Study Design This prospective cross-sectional investigation was conducted from December 2024 to May 2025, involving both patient and control cohorts. Prior to enrollment, all participants provided written and verbal informed consent following a detailed explanation of the study objectives. The research protocol received full ethical approval from the Human Research Ethics Committee (2024-GOKAEK-2411_2024.10.16_188), ensuring adherence to international ethical guidelines. Patient enrollment start date: 22/12/2024, and ClinicalTrials.gov registration ID: NCT06348017.
Patients The study was commenced after obtaining the approval of the local ethics committee and the informed consent of the participants. Patients who applied to the University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, met the 2010 ACR criteria for Rheumatoid Arthritis, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the RA group; those who met the Modified New York criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the AS group; and those who met the Classification of Psoriatic Arthritis (CASPAR criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the PSA group. After completing the surveys of patients with patient group, the gender and age distribution of the patient group was determined. The patient control group consisted of individuals who visited the Physical Medicine and Rehabilitation clinic of the University Faculty of Medicine due to knee pain lasting six months or longer, were diagnosed with knee osteoarthritis, matched the patient group in terms of age and gender, demonstrated adequate cognitive abilities, possessed literacy skills, and agreed to take part in the study. The control group included healthy individuals who were of the same age and gender to the patient group, had good cognitive functions, were literate, had no disease or complaints, and agreed to take part in the study.
The sociodemographic questionnaire, which was the data collection tool, was administered face-to-face to individuals at the Physical Medicine and Rehabilitation clinic along with several assessment scales: the Disease Activity Score 28 (DAS28), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Disease Activity Index for Psoriatic Arthritis (DAPSA), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Beck Depression Inventory (BDI), and the Beck Anxiety Inventory (BAI), as well as the Turkey Health Literacy Scale-32 (THLS-32), the Rational Drug Use Scale (RDUS), and the Cyberchondria Severity Scale (CSS).
DAS28: In patients with RA, disease activity is assessed using the DAS28 scale. This method is a widely used tool to determine disease activity in RA. The evaluation involves assessing 28 joints for tenderness and swelling. The patient's global pain assessment score, along with C-reactive protein (CRP) levels or erythrocyte sedimentation rate (ESR), is entered into a computer program to calculate the DAS28 score. A total score >5.1 indicates high disease activity, a score between 3.2-5.1 indicates moderate disease activity, a score <3.2 indicates low disease activity, and a score <2.6 is considered remission [29].
BASDAI: The BASDAI is used to evaluate disease activity in patients with AS. As the BASDAI score increases, the level of disability associated with the disease also rises. A BASDAI score ≥4 indicates active disease. The Turkish validity and reliability study of the BASDAI was conducted in 2005 [30].
DAPSA: Disease activity in patients with PSA is assessed using the DAPSA score. This method is based on the evaluation of 68 joints for tenderness and 66 joints for swelling. The number of tender and swollen joints, the pain assessment score via the Visual Analog Scale (VAS), the physician's global assessment, and CRP values are summed to calculate the DAPSA score. A score >28 indicates high disease activity, a score between 15-28 indicates moderate disease activity, a score between 5-14 indicates low disease activity, and a score <4 is considered remission [31].
WOMAC: is a tool commonly used to assess the level of functional impairment in patients with knee osteoarthritis. It includes 24 items divided into three domains: pain, stiffness, and physical function. Each item is rated on a scale from 0 (none) to 4 (extreme), with higher total scores reflecting greater severity of symptoms and functional limitations. The Turkish adaptation of the WOMAC was validated by Tüzün et al. [32].
BDI: is developed by Beck and colleagues in 1961, is intended to evaluate the typical signs and symptoms associated with depression. This instrument is a self-administered questionnaire comprising 21 items and usually requires around 10 minutes to complete. The Turkish version of the inventory was adapted and validated by Hisli and colleagues [33].
BAI: is developed by Aaron T. Beck, is an internationally validated tool for assessing anxiety levels. It consists of 21 items. The Turkish adaptation and validation of the inventory were performed by Ulusoy and colleagues [34].
THLS-32: Developed and validated by Okyay and colleagues [35], the THLS-32 measures HL levels. It has two sub-groups: treatment service score and disease prevention score, but there is no separate cut-off value determined for these sub-scales; the higher the score, the higher the literacy. Scores range from 0 to 50, where 0 indicates the lowest and 50 the highest level of HL. HL levels are categorized as follows: 0-25 points indicate "inadequate" HL, >25-33 points indicate "problematic/limited," >33-42 points indicate "adequate," and >42-50 points indicate "excellent" HL.
RDUS: Developed by Demirtaş and colleagues, this scale has undergone a Turkish validity and reliability study [36]. It consists of 21 items scored on a 3-point Likert scale. Responses are scored as "correct answer = 2 points," "I don't know = 1 point," and "wrong answer = 0 points." Total scores range from 0 to 42, with higher scores indicating better levels of RDU. A cutoff score of 34 and above is interpreted as "good RDU." The Cronbach's alpha coefficient for the scale is 0.78.
CSS: Adapted into Turkish by Uzun and Zencir [37], this scale comprises 33 items rated on a 5-point Likert scale, ranging from "Never" to "Always." The scale has five subdimensions: compulsion, excessive concern, excessive searching, reassurance seeking, and distrust of medical professionals. Compulsion, excessive concern, and excessive searching subscales range from 8 to 40 points, reassurance seeking ranges from 6 to 30 points, and distrust of medical professionals ranges from 3 to 15 points. The total score ranges from 33 to 165, with higher scores indicating higher levels of cyberchondria. The overall Cronbach's alpha coefficient of the scale is 0.94.
Statistical analysis Sample analysis was performed using the Openepi application https://www.openepi.com/SampleSize/SSPropor.htm). Based on the study by Kalmaz et al., it was determined that at least 75 participants should be included in each group for a margin of error of 0.05, an effect size of 0.465, and 95% power [28]. Data analysis was conducted using SPSS version 25.0 (SPSS Inc., Armonk, NY). The Kolmogorov-Smirnov test was applied to assess the normality of continuous variables. Categorical data were evaluated with Pearson's Chi-Square Test or Fisher's Exact Test depending on the expected frequencies. For continuous variables, group differences were analyzed using the Student's T-Test or One-Way Analysis of Variance (ANOVA). When multiple group comparisons were necessary, post-hoc analyses were performed using Tukey's or Games-Howell tests. Spearman's correlation coefficients were calculated to explore relationships between variables and disease activity or scale scores, including DAS28, BASDAI, DAPSA, WOMAC, BDI, BAI, THLS-32, RDUS, and CSS within the patient cohort.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Patients who applied to the University Faculty of Medicine, Physical Medicine and Rehabilitation outpatient clinic, met the 2010 ACR criteria for Rheumatoid Arthritis, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the RA group; those who met the Modified New York criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the AS group; and those who met the Classification of Psoriatic Arthritis (CASPAR criteria, were aged 18 to 65, had intact cognitive functions, were literate, and consented to participate were included in the PSA group |
| Control patient group | – | –After completing the surveys of patients with patient group, the gender and age distribution of the patient group was determined. The patient control group consisted of individuals who visited the Physical Medicine and Rehabilitation clinic of the University Faculty of Medicine due to knee pain lasting six months or longer, were diagnosed with knee osteoarthritis, matched the patient group in terms of age and gender, demonstrated adequate cognitive abilities, possessed literacy skills, and agreed to take part in the study. |
| control group | – | –The control group included healthy individuals who were of the same age and gender to the patient group, had good cognitive functions, were literate, had no disease or complaints, and agreed to take part in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 65 years, including patients diagnosed with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or knee osteoarthritis, as well as healthy controls matched for age and gender. All participants had sufficient cognitive abilities, were literate, and consented to participate.
Key inclusion criteria (7 listed)
- Obtained approval from the local ethics committee. Provided informed consent to participate. Aged 18 to 65 years. Possessed intact cognitive functions. Literate. For the Rheumatoid Arthritis (RA) group: Met the 2010 ACR criteria for Rheumatoid Arthritis.
- For the Ankylosing Spondylitis (AS) group: Met the Modified New York criteria. For the Psoriatic Arthritis (PsA) group: Met the Classification of Psoriatic Arthritis (CASPAR) criteria.
- Visited the Physical Medicine and Rehabilitation clinic due to knee pain lasting six months or longer.
- Diagnosed with knee osteoarthritis. Matched the patient group in terms of age and gender. Demonstrated adequate cognitive abilities. Possessed literacy skills.
- Same age and gender as the patient group. Had good cognitive functions. Literate. Had no disease or complaints.
Key exclusion criteria (2 listed)
- Under the age of 18 or over the age of 65. Any condition that could impair communication. Refusal to participate in the study. Not possessing digital devices such as a smartphone or computer, or lacking internet access.
- Illiterate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Turkey Health Literacy Scale-32 (THLS-32)
Time frame: At enrollment
Developed and validated by Okyay and colleagues, the THLS-32 measures HL levels. It has two sub-groups: treatment service score and disease prevention score, but there is no separate cut-off value determined for these sub-scales; the higher the score, the higher the literacy. Scores range from 0 to 50, where 0 indicates the lowest and 50 the highest level of HL. HL levels are categorized as follows: 0-25 points indicate "inadequate" HL, >25-33 points indicate "problematic/limited," >33-42 points indicate "adequate," and >42-50 points indicate "excellent" HL.
Rational Drug Use Scale (RDUS),
Time frame: At enrollment
Developed by Demirtaş and colleagues, this scale has undergone a Turkish validity and reliability study. It consists of 21 items scored on a 3-point Likert scale. Responses are scored as "correct answer = 2 points," "I don't know = 1 point," and "wrong answer = 0 points." Total scores range from 0 to 42, with higher scores indicating better levels of RDU. A cutoff score of 34 and above is interpreted as "good RDU." The Cronbach's alpha coefficient for the scale is 0.78.
Cyberchondria Severity Scale (CSS)
Time frame: At enrollment
Adapted into Turkish by Uzun and Zencir, this scale comprises 33 items rated on a 5-point Likert scale, ranging from "Never" to "Always." The scale has five subdimensions: compulsion, excessive concern, excessive searching, reassurance seeking, and distrust of medical professionals. Compulsion, excessive concern, and excessive searching subscales range from 8 to 40 points, reassurance seeking ranges from 6 to 30 points, and distrust of medical professionals ranges from 3 to 15 points. The total score ranges from 33 to 165, with higher scores indicating higher levels of cyberchondria. The overall Cronbach's alpha coefficient of the scale is 0.94.
the Disease Activity Score 28 (DAS28)
Time frame: At enrollment
In patients with RA, disease activity is assessed using the DAS28 scale. This method is a widely used tool to determine disease activity in RA. The evaluation involves assessing 28 joints for tenderness and swelling. The patient's global pain assessment score, along with C-reactive protein (CRP) levels or erythrocyte sedimentation rate (ESR), is entered into a computer program to calculate the DAS28 score. A total score >5.1 indicates high disease activity, a score between 3.2-5.1 indicates moderate disease activity, a score <3.2 indicates low disease activity, and a score <2.6 is considered remission.
the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI),
Time frame: At enrollment
The BASDAI is used to evaluate disease activity in patients with AS. As the BASDAI score increases, the level of disability associated with the disease also rises. A BASDAI score ≥4 indicates active disease. The Turkish validity and reliability study of the BASDAI was conducted in 2005.
the Disease Activity Index for Psoriatic Arthritis (DAPSA)
Time frame: At enrollment
Disease activity in patients with PSA is assessed using the DAPSA score. This method is based on the evaluation of 68 joints for tenderness and 66 joints for swelling. The number of tender and swollen joints, the pain assessment score via the Visual Analog Scale (VAS), the physician's global assessment, and CRP values are summed to calculate the DAPSA score. A score >28 indicates high disease activity, a score between 15-28 indicates moderate disease activity, a score between 5-14 indicates low disease activity, and a score <4 is considered remission.
the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC),
Time frame: At enrollment
is a tool commonly used to assess the level of functional impairment in patients with knee osteoarthritis. It includes 24 items divided into three domains: pain, stiffness, and physical function. Each item is rated on a scale from 0 (none) to 4 (extreme), with higher total scores reflecting greater severity of symptoms and functional limitations. The Turkish adaptation of the WOMAC was validated by Tüzün et al.
the Beck Depression Inventory (BDI),
Time frame: At enrollment
BDI: is developed by Beck and colleagues in 1961, is intended to evaluate the typical signs and symptoms associated with depression. This instrument is a self-administered questionnaire comprising 21 items and usually requires around 10 minutes to complete. The Turkish version of the inventory was adapted and validated by Hisli and colleagues.
the Beck Anxiety Inventory (BAI),
Time frame: At enrollment
is developed by Aaron T. Beck, is an internationally validated tool for assessing anxiety levels. It consists of 21 items. The Turkish adaptation and validation of the inventory were performed by Ulusoy and colleagues.
Visual Analog Scale (VAS)
Time frame: At enrollment
For the Evaluation of Pain. For this evaluation, the patient is asked to mark their pain and fatigue severity on a horizontal 10-cm line with the number 0 on one end representing "no pain or no fatigue" and the number 10 on the other end indicating "very severe pain or very severe fatigue."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 14730386Akkoc 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülseren Demir Karakılıç, Asst Prof principal investigator
Yozgat Bozok University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Health Literacy, 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 7 inclusion and 2 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 24 Sep 2026. 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?
Turkey Health Literacy Scale-32 (THLS-32) (time frame: At enrollment). The study lists 10 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 NCT06993935, which also lists 1 linked publication.
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 24 Sep 2026.