Knee OsteoarthristisT-ASES-8NCT06929741
Turkish Version of the Arthritis Self-Efficacy Scale-8
An observational study of Knee Osteoarthristis and Self Efficacy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Self-efficacy is a psychosocial construct that reflects an individual's confidence in their ability to perform specific tasks, focusing more on one's belief in their abilities than on actual performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis, Self Efficacy
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 1 May 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study targets adult patients aged 18 years and older who have been diagnosed with knee osteoarthritis (KOA) based on the American College of Rheumatology (ACR) criteria. Participants must possess sufficient language proficiency to understand and complete the Turkish version of the ASES-8 scale and must be willing to provide informed consent. The study excludes individuals with health conditions that render them unsuitable for self-management programs, those with behavioral or cognitive impairments that could interfere with the assessment process, and patients with unstable angina or uncontrolled heart failure.
Who may be able to join
- Age ≥ 18 years
- Diagnosis of knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria
- Sufficient language skills to understand and complete the scale
- Provision of informed consent
Who cannot join
- Health conditions unsuitable for a self-management program
- Behavioral or cognitive issues that could hinder the assessment process
- Unstable angina or uncontrolled heart failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Cross-cultural Adaptation and Validation of a Turkish Version of the Arthritis Self-Efficacy Scale-8 (ASES-8) for Patients With Knee Osteoarthritis
Self-efficacy is a psychosocial construct that reflects an individual's confidence in their ability to perform specific tasks, focusing more on one's belief in their abilities than on actual performance. This concept is especially important in knee osteoarthritis (KOA) management, as it can significantly influence overall health and treatment outcomes, and it is considered a modifiable trait.
KOA is one of the most common musculoskeletal disorders worldwide, substantially impacting quality of life due to symptoms such as limited mobility, chronic pain, and joint stiffness. These symptoms can hinder daily activities and potentially lead to social isolation. In patients with KOA, a strong sense of self-efficacy can improve symptom management and increase participation in physical activities. Research indicates that patients with higher self-efficacy are more likely to engage actively in rehabilitation programs and achieve their treatment goals. Consequently, various self-efficacy measurement tools have been developed to better understand patients' perceptions of their condition and the extent of their disability, which in turn aids in formulating strategies to enhance self-efficacy and optimize treatment responses.
Read more
The Arthritis Self-Efficacy Scale (ASES) is widely used to assess self-efficacy in managing pain, physical functions, and other symptoms associated with arthritis. Compared to other self-efficacy instruments, the ASES has a longstanding history and is particularly applicable to KOA. Its validity and reliability have been confirmed through several studies. Initially developed as a 20-item scale with three subscales evaluating physical function, pain, and other symptoms, a shorter version-the eight-item ASES-8-was later created. This abbreviated version includes two items from the pain subscale, four items from the other symptoms subscale, and two additional items addressing fatigue and pain prevention during daily activities. Each item is rated on a scale from 1 (very uncertain) to 10 (very certain), indicating the patient's level of confidence in managing their condition.
Although the ASES-8 has been validated in several languages, it has not yet been translated into Turkish or culturally adapted for Turkish patients with KOA. Cross-cultural adaptation of patient-reported outcome measures (PROMs) requires rigorous methodologies to ensure both accurate translation and the preservation of content validity. Reliable, valid, and culturally sensitive instruments are essential for developing effective interventions for Turkish-speaking patients with KOA. Therefore, this study aims to translate and cross-culturally adapt the ASES-8 into Turkish and evaluate the reliability and validity of the resulting instrument.
- Conditions
- Knee Osteoarthristis, Self Efficacy
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 |
|---|---|---|
| Patients with Knee Osteoarthritis (KOA) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct Validity and Reliability of the Turkish ASES-8
Self-Efficacy in Knee Osteoarthritis (KOA) Management
The primary outcome of our study is to assess the level of self-efficacy in managing KOA among Turkish-speaking patients. This is operationalized through the culturally adapted version of the Arthritis Self-Efficacy Scale-8 item version (ASES-8).
Key Features of the Primary Outcome Measure:
Instrument Overview:
The ASES-8 is designed to evaluate the patient's confidence in managing key symptoms associated with KOA-including pain, functional limitations, fatigue, and pain prevention during daily activities. Unlike performance-based tests, this instrument focuses on patients' beliefs about their own abilities to manage these aspects, which is crucial for effective self-management.
Measurement Details:
Item Structure: The ASES-8 consists of eight items. Two items are derived from the pain subscale, four from the other symptoms subscale, and two additional items address fatigue and preventive strategies against pain during daily ac
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start15 Apr 2025
- Primary completion25 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929741
- Sponsor's protocol ID
- 2023/211
- Acronym
- T-ASES-8
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 7 May 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of a Turkish Version of the Arthritis Self-Efficacy Scale-8 (ASES-8) for Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06929741
- Acronym / sponsor ID
- T-ASES-8 / 2023/211
- Conditions
- Knee Osteoarthristis, Self Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 16 Apr 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.
Self-efficacy is a psychosocial construct that reflects an individual's confidence in their ability to perform specific tasks, focusing more on one's belief in their abilities than on actual performance. This concept is especially important in knee osteoarthritis (KOA) management, as it can significantly influence overall health and treatment outcomes, and it is considered a modifiable trait.
KOA is one of the most common musculoskeletal disorders worldwide, substantially impacting quality of life due to symptoms such as limited mobility, chronic pain, and joint stiffness. These symptoms can hinder daily activities and potentially lead to social isolation. In patients with KOA, a strong sense of self-efficacy can improve symptom management and increase participation in physical activities. Research indicates that patients with higher self-efficacy are more likely to engage actively in rehabilitation programs and achieve their treatment goals. Consequently, various self-efficacy measurement tools have been developed to better understand patients' perceptions of their condition and the extent of their disability, which in turn aids in formulating strategies to enhance self-efficacy and optimize treatment responses.
The Arthritis Self-Efficacy Scale (ASES) is widely used to assess self-efficacy in managing pain, physical functions, and other symptoms associated with arthritis. Compared to other self-efficacy instruments, the ASES has a longstanding history and is particularly applicable to KOA. Its validity and reliability have been confirmed through several studies. Initially developed as a 20-item scale with three subscales evaluating physical function, pain, and other symptoms, a shorter version-the eight-item ASES-8-was later created. This abbreviated version includes two items from the pain subscale, four items from the other symptoms subscale, and two additional items addressing fatigue and pain prevention during daily activities. Each item is rated on a scale from 1 (very uncertain) to 10 (very certain), indicating the patient's level of confidence in managing their condition.
Although the ASES-8 has been validated in several languages, it has not yet been translated into Turkish or culturally adapted for Turkish patients with KOA. Cross-cultural adaptation of patient-reported outcome measures (PROMs) requires rigorous methodologies to ensure both accurate translation and the preservation of content validity. Reliable, valid, and culturally sensitive instruments are essential for developing effective interventions for Turkish-speaking patients with KOA. Therefore, this study aims to translate and cross-culturally adapt the ASES-8 into Turkish and evaluate the reliability and validity of the resulting instrument.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Knee Osteoarthritis (KOA) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study targets adult patients aged 18 years and older who have been diagnosed with knee osteoarthritis (KOA) based on the American College of Rheumatology (ACR) criteria. Participants must possess sufficient language proficiency to understand and complete the Turkish version of the ASES-8 scale and must be willing to provide informed consent. The study excludes individuals with health conditions that render them unsuitable for self-management programs, those with behavioral or cognitive impairments that could interfere with the assessment process, and patients with unstable angina or uncontrolled heart failure.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Diagnosis of knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria
- Sufficient language skills to understand and complete the scale
- Provision of informed consent
Key exclusion criteria (3 listed)
- Health conditions unsuitable for a self-management program
- Behavioral or cognitive issues that could hinder the assessment process
- Unstable angina or uncontrolled heart failure
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
Construct Validity and Reliability of the Turkish ASES-8
Time frame: 1 month
Self-Efficacy in Knee Osteoarthritis (KOA) Management The primary outcome of our study is to assess the level of self-efficacy in managing KOA among Turkish-speaking patients. This is operationalized through the culturally adapted version of the Arthritis Self-Efficacy Scale-8 item version (ASES-8). Key Features of the Primary Outcome Measure: Instrument Overview: The ASES-8 is designed to evaluate the patient's confidence in managing key symptoms associated with KOA-including pain, functional limitations, fatigue, and pain prevention during daily activities. Unlike performance-based tests, this instrument focuses on patients' beliefs about their own abilities to manage these aspects, which is crucial for effective self-management. Measurement Details: Item Structure: The ASES-8 consists of eight items. Two items are derived from the pain subscale, four from the other symptoms subscale, and two additional items address fatigue and preventive strategies against pain during daily ac
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 7 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Osteoarthristis and Self Efficacy, run by Bezmialem Vakif University 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 4 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 7 May 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?
Construct Validity and Reliability of the Turkish ASES-8 (time frame: 1 month). 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 7 May 2025.