Cardiovascular Disease RiskNCT07056608
Cardiovascular Disease Awareness in Rheumatoid Arthritis and Knee Osteoarthritis
An observational study of Cardiovascular Disease Risk and Rheumatoid Arthritis (RA), run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular diseases (CVD) are still the most common cause of death. For these reasons, individuals, especially those with chronic diseases, need to be aware of CVD. CVD is also a significant cause of morbidity and mortality in rheumatoid arthritis (RA). Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Cardiovascular Disease Risk, Rheumatoid Arthritis (RA), Knee Osteoarthritis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 15 Sep 2025
- How long will I take part?
- 3 Months
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients diagnosed with rheumatoid arthritis or knee osteoarthritis
Who may be able to join
- Patients aged 40 and over
- Patients diagnosed with rheumatoid arthritis or osteoarthritis
- Volunteering to participate in the study
Who cannot join
- Patients who cannot ambulate
- Patients who cannot be evaluated due to cognitive reasons
- Those who are not receiving enteral nutrition or whose general condition is so poor that they cannot exercise
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Cardiovascular Disease Awareness in Patients With Rheumatoid Arthritis and Knee Osteoarthritis: A Cross-Sectional Study
Cardiovascular diseases (CVD) are still the most common cause of death. For these reasons, individuals, especially those with chronic diseases, need to be aware of CVD. CVD is also a significant cause of morbidity and mortality in rheumatoid arthritis (RA). This study aimed to compare CVD awareness in RA and knee osteoarthritis (KOA).
Read the detailed description
Patients who apply to our Physical Medicine and Rehabilitation clinic and are followed up with the diagnosis of RA and (KOA) will be screened. Demographic values such as age, gender, height, weight, smoking and alcohol use, diseases and medications used, cardiovascular disease awareness will be assessed with the Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL), exercise levels with the International Physical Activity Questionnaire (IPAQ), and nutritional habits with the Nutrition Attitude Scale (NAS). Cardiovascular risk calculation will be made with the Framingham Risk Score. It will also be ensured that patients with high risk are directed to the relevant branches. In addition, the Timed Up and Go Test (TUG), which is a prognosis indicator for cardiovascular diseases, will be performed. All surveys will be filled out in both groups and compared in terms of cardiovascular risk awareness.
- Keywords
- Cardiovascular disease risk, rheumatoid arthritis, knee osteoarthritis, Cardiovascular Disease Risk Factors Knowledge Level
- Medical subject headings
- Arthritis, Rheumatoid, 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 |
|---|---|---|
| Rheumatoid arthritis | Female patients aged 40 years and over with rheumatoid arthritis | |
| Knee osteoarthritis | Female patients aged 40 years and over diagnosed with knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Disease Risk Factors Knowledge Level
This scale consists of 28 items. The first four items question the characteristics, protection and age factor of CVDs, 15 items question risk factors, and 9 items question the results of changes in risk behaviors. The items are answered as "Yes", "No" or "I don't know" and 1 point is given for each correct answer. The highest total score is 28. As the scores increase, the level of knowledge increases.
Measured: Day 1
Secondary outcomes (3)
International Physical Activity Questionnaire
The short form of the questionnaire was used in this study. This short form consists of seven questions and provides information about the time spent in sitting, walking, moderate activities and vigorous activities. In activity assessment, the criterion is that each activity is performed for at least 10 minutes at a time. A score is obtained as "MET-min/week" by multiplying the time in minutes, the number of days and the MET value corresponding to the basal metabolic rate (multiples of resting oxygen consumption). Accordingly, the physical activity levels of the participants are classified as inactive, minimally active and very active according to the total physical activity score.
Measured: Day 1
Nutrition Attitude Scale
The lowest score from the nutrition attitude scale is 21 and the highest score is 105. High scores from the scale indicate that individuals who fill out the scale have a high attitude towards nutrition, while individuals who receive low scores indicate that their attitude towards nutrition is low. It can be said that individuals with high attitude scores towards nutrition are sensitive to weight control and health.
Measured: Day 1
Timed Up and Go Test
This test involves the individual getting up from a chair, walking 3 meters, returning and sitting on the chair. A stopwatch is kept during this process. If this time is 12 seconds or more, the individual is at risk of falling. This test is also used in cardiovascular disease risk assessments.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease RiskStudies 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
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Çiftci, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Banu Kuran, Professor, Medical Doctor, Study director, Şişli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056608
- Sponsor's protocol ID
- 5.20.2025/approval no:4866
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiovascular Disease Awareness in Patients With Rheumatoid Arthritis and Knee Osteoarthritis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07056608
- Acronym / sponsor ID
- 5.20.2025/approval no:4866
- Keywords
- Cardiovascular disease risk, rheumatoid arthritis, knee osteoarthritis, Cardiovascular Disease Risk Factors Knowledge Level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 9 Jul 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.
Cardiovascular diseases (CVD) are still the most common cause of death. For these reasons, individuals, especially those with chronic diseases, need to be aware of CVD. CVD is also a significant cause of morbidity and mortality in rheumatoid arthritis (RA). This study aimed to compare CVD awareness in RA and knee osteoarthritis (KOA).
Detailed description
Patients who apply to our Physical Medicine and Rehabilitation clinic and are followed up with the diagnosis of RA and (KOA) will be screened. Demographic values such as age, gender, height, weight, smoking and alcohol use, diseases and medications used, cardiovascular disease awareness will be assessed with the Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL), exercise levels with the International Physical Activity Questionnaire (IPAQ), and nutritional habits with the Nutrition Attitude Scale (NAS). Cardiovascular risk calculation will be made with the Framingham Risk Score. It will also be ensured that patients with high risk are directed to the relevant branches. In addition, the Timed Up and Go Test (TUG), which is a prognosis indicator for cardiovascular diseases, will be performed. All surveys will be filled out in both groups and compared in terms of cardiovascular risk awareness.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | – | –Female patients aged 40 years and over with rheumatoid arthritis |
| Knee osteoarthritis | – | –Female patients aged 40 years and over diagnosed with knee osteoarthritis |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagnosed with rheumatoid arthritis or knee osteoarthritis
Key inclusion criteria (3 listed)
- Patients aged 40 and over
- Patients diagnosed with rheumatoid arthritis or osteoarthritis
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Patients who cannot ambulate
- Patients who cannot be evaluated due to cognitive reasons
- Those who are not receiving enteral nutrition or whose general condition is so poor that they cannot exercise
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
Cardiovascular Disease Risk Factors Knowledge Level
Time frame: Day 1
This scale consists of 28 items. The first four items question the characteristics, protection and age factor of CVDs, 15 items question risk factors, and 9 items question the results of changes in risk behaviors. The items are answered as "Yes", "No" or "I don't know" and 1 point is given for each correct answer. The highest total score is 28. As the scores increase, the level of knowledge increases.
3 secondary outcomes
International Physical Activity Questionnaire
Time frame: Day 1
Nutrition Attitude Scale
Time frame: Day 1
Timed Up and Go Test
Time frame: Day 1
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 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Banu Kuran, Professor, Medical Doctor study director
Şişli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey
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 Cardiovascular Disease Risk and Rheumatoid Arthritis (RA), run by Sisli Hamidiye Etfal Training and Research Hospital 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 3 inclusion and 3 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 19 Nov 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?
Cardiovascular Disease Risk Factors Knowledge Level (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.