Psychometric Properties of the Short Form 12-item (SF-12) Health Questionnaire in Individuals With Knee Osteoarthritis

NCT06004024 | Unknown

• 1 other identifier: MedipolU
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Knee Osteoarthritis (OA) is one of the most common joint diseases with chronic low-severity inflammation. 80% of individuals with knee OA have limited movements; It was found that 25% of them could not do their daily work. In addition, it has been shown that the quality of life of individuals with OA is lower compared to healthy individuals. This showed that measuring and reporting quality of life should be mandatory in clinical studies conducted in individuals with knee OA. It was stated that the most frequently used general scales in the evaluation of quality of life in these individuals were SF-36 or SF-12. It takes a long time for the SF-36 to be filled by individuals, which creates a disadvantage for both patients and clinicians. Developed as a shorter alternative to SF-36, SF-12 has also been shown to give similar results to SF-36 in individuals with knee OA who have undergone total knee arthroplasty. However, the psychometric properties of SF-12 in individuals with knee OA have not been examined. The purpose of this study is to examine whether SF-12 is valid and reliable in individuals with knee OA and to determine the minimum detectable change (MDC) value.

Conditions

Knee Osteoarthritis; Quality of Life

Keywords

SF-12; knee osteoarthritis; validity; reliability; minimal detectable change

Outcome Measures

Primary Outcomes (3)

• Health Status Questionnaire (Short Form-SF-36)

  The SF-36 is a widely used self-reported general health status questionnaire that measures eight dimensions of health status. Physical functioning, role restrictions due to physical health problems, bodily pain, social functionality, general mental health, role restrictions due to emotional problems, vitality and general health perceptions. It is a form that evaluates the last 4 weeks. While these eight sub-dimensions can be scored separately, the physical and mental component summary score (FCS and MCS score, respectively; Physical and Mental Component Summary Scores) can be obtained by weighing them and providing a general assessment of physical and mental health.

  Evaluation data will be collected within six month.

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  WOMAC will be used to assess patients' knee pain, joint stiffness and function. WOMAC is a disease-specific health status measure frequently used in patients with knee and hip OA. WOMAC consists of 24 questions, 5 questions in the pain section, 2 questions in the stiffness section, and 17 questions in the function section.

  Evaluation data will be collected within six month.

• Short Form 12-Item (SF-12) Health Survey

  The 12-item short form health questionnaire (SF-12) is a measure of physical and mental health. It has been reported that SF-12, which was created from the original form, SF-36, is more advantageous in terms of ease of application and shorter completion time. While the PCS-12 score is obtained from the sub-dimensions of general health, physical functionality, physical role and body pain, the MCS-12 score is obtained from the sub-dimensions of social functionality, emotional role, mental health and energy.

  Evaluation data will be collected within six month.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research will be carried out in Aydın ARSLAN Orthopedics and Traumatology Clinic, which is connected to the province of Istanbul, in individuals aged 40 and over who are diagnosed with knee osteoarthritis.

You may qualify if:

• years and older,
• Radiological and clinical diagnosis of knee OA,
• Volunteering to participate in the study,
• Ability to read and write

You may not qualify if:

• Having problems with cooperation or cognitive impairment,
• Previous total knee arthroplasty surgery,
• Presence of neurodegenerative or neuromuscular disease,
• Psychological disorders,
• Presence of depression

Sponsors & Collaborators

• Meltem Meran Çağlar: lead

Study Sites (1)

Meltem Meran Çağlar

Istanbul, İ̇stanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Meltem Meran Çağlar

  Medipol University

  STUDY CHAIR

Central Study Contacts

Meltem Meran Çağlar

CONTACT

05412210058; meltem.meran@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)