NCT06929741

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 7, 2025

Status Verified

May 1, 2025

Enrollment Period

10 days

First QC Date

April 7, 2025

Last Update Submit

May 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (1)

Patients with Knee Osteoarthritis (KOA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Health conditions unsuitable for a self-management program
  • Behavioral or cognitive issues that could hinder the assessment process
  • Unstable angina or uncontrolled heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 16, 2025

Study Start

April 15, 2025

Primary Completion

April 25, 2025

Study Completion

May 1, 2025

Last Updated

May 7, 2025

Record last verified: 2025-05

Locations