Knee OsteoarthritisSF-12NCT06004024
Psychometric Properties of the Short Form 12-item (SF-12) Health Questionnaire in Individuals With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Quality of Life, run by Meltem Meran Çağlar at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Quality of Life
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Nov 2024
- How long will I take part?
- 1 Year
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 40 years and older,
- Radiological and clinical diagnosis of knee OA,
- Volunteering to participate in the study,
- Ability to read and write
Who cannot join
- Having problems with cooperation or cognitive impairment,
- Previous total knee arthroplasty surgery,
- Presence of neurodegenerative or neuromuscular disease,
- Psychological disorders,
- Presence of depression
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Meltem Meran Çağlar
Istanbul, İ̇stanbul
Meltem Meran Çağlar, 05412210058, meltem.meran@gmail.com
About this study
Official title: Validity, Reliability, and Smallest Detectable Change of the Short Form 12-Item (SF-12) Health Survey in Individuals With Knee Osteoarthritis: A Cross-sectional Study
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.
Read the detailed description
Forty volunteers aged 40 years and older diagnosed with knee OA will be included in the study. First, individuals will be informed about the study in detail, and signed informed consent form will be obtained from individuals who agree to participate in the study. First of all, the demographic information of the individuals will be recorded. Chronic diseases and continuous drug use will be questioned. Individuals' quality of life will be evaluated with the SF-12 and SF-36 scales, and their functional status will be evaluated with the WOMAC score. All scales will be filled once, but the second evaluation for the test-retest reliability (intra-rater reliability) of the SF-12 scale will be repeated one week later. In our study, the sample size was determined by using a web-based sample size calculation application specially developed for reliability-validity studies. In this application, hypothesis testing was performed according to ICC values. The minimum acceptable reliability (ICC) was 0.65 and the expected reliability from the study was 0.85. When the significance level of the study (α) was determined as 0.05 and the power of the study (1-β) was determined as 80%, and considering the probability that 10% of the individuals participating in the study could exit the study, it was found that the minimum sample size to be taken for the study should be 40 people. Jamovi 2.3.28 program will be used in the statistical analysis of the data. Variables determined by measurement will be expressed as mean ± standard deviation (X ± SD), percent (%) will be calculated for variables determined by counting. The normal distribution will be evaluated by examining both visually (Histogram and Q-Q plots) and statistical techniques (Kolmogorov Smirnov test, Skewness and Kurtosis values). Criterion-releated validity of SF-12 will be evaluated by its subtype, concurrent validity, and its correlation with WOMAC and SF-36 scales will be evaluated. Pearson correlation test will be applied when the correlation normal distribution conditions are met, and Spearman correlation test will be applied if not. Correlation coefficient level will be considered as <0.3 low, 0.3- 0.5 medium, >0.5 strong. In the reliability test of the SF-12 scale, test-re-test will be applied for the stability of the scale, and intra-class correlational coefficients (ICC) will be calculated. ICC values of 0.5-0.75 will indicate moderate reliability, 0.75-0.9 good reliability, and >0.9 excellent reliability. In order to determine the internal consistency of the scale, internal consistency coefficients (Cronbach's alpha) will be calculated. It will be at an acceptable level when Cronbach's alpha is >0.7. Absolute reliability will be determined by calculating the standard error of measurement (SEM) to ensure the accuracy of the measurement. The SEM will be used to calculate the smallest detectable change at the 95% confidence level (MDC95) and will be calculated as: MDC95=SEM × 1.95 × √2. In all statistics, the "p" significance value will be taken as 0.05.
- Conditions
- Knee Osteoarthritis, Quality of Life
- Keywords
- SF-12, knee osteoarthritis, validity, reliability, minimal detectable change
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Evaluation data will be collected within six month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Meltem Meran Çağlar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meltem Meran Çağlar, Beykoz University
- Investigators
- Meltem Meran Çağlar, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004024
- Sponsor's protocol ID
- MedipolU
- Acronym
- SF-12
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability, and Smallest Detectable Change of the Short Form 12-Item (SF-12) Health Survey in Individuals With Knee Osteoarthritis: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06004024
- Acronym / sponsor ID
- SF-12 / MedipolU
- Conditions
- Knee Osteoarthritis, Quality of Life
- Keywords
- SF-12, knee osteoarthritis, validity, reliability, minimal detectable change
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meltem Meran ÇağlarUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 22 Aug 2023 (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.
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.
Detailed description
Forty volunteers aged 40 years and older diagnosed with knee OA will be included in the study. First, individuals will be informed about the study in detail, and signed informed consent form will be obtained from individuals who agree to participate in the study. First of all, the demographic information of the individuals will be recorded. Chronic diseases and continuous drug use will be questioned. Individuals' quality of life will be evaluated with the SF-12 and SF-36 scales, and their functional status will be evaluated with the WOMAC score. All scales will be filled once, but the second evaluation for the test-retest reliability (intra-rater reliability) of the SF-12 scale will be repeated one week later. In our study, the sample size was determined by using a web-based sample size calculation application specially developed for reliability-validity studies. In this application, hypothesis testing was performed according to ICC values. The minimum acceptable reliability (ICC) was 0.65 and the expected reliability from the study was 0.85. When the significance level of the study (α) was determined as 0.05 and the power of the study (1-β) was determined as 80%, and considering the probability that 10% of the individuals participating in the study could exit the study, it was found that the minimum sample size to be taken for the study should be 40 people. Jamovi 2.3.28 program will be used in the statistical analysis of the data. Variables determined by measurement will be expressed as mean ± standard deviation (X ± SD), percent (%) will be calculated for variables determined by counting. The normal distribution will be evaluated by examining both visually (Histogram and Q-Q plots) and statistical techniques (Kolmogorov Smirnov test, Skewness and Kurtosis values). Criterion-releated validity of SF-12 will be evaluated by its subtype, concurrent validity, and its correlation with WOMAC and SF-36 scales will be evaluated. Pearson correlation test will be applied when the correlation normal distribution conditions are met, and Spearman correlation test will be applied if not. Correlation coefficient level will be considered as <0.3 low, 0.3- 0.5 medium, >0.5 strong. In the reliability test of the SF-12 scale, test-re-test will be applied for the stability of the scale, and intra-class correlational coefficients (ICC) will be calculated. ICC values of 0.5-0.75 will indicate moderate reliability, 0.75-0.9 good reliability, and >0.9 excellent reliability. In order to determine the internal consistency of the scale, internal consistency coefficients (Cronbach's alpha) will be calculated. It will be at an acceptable level when Cronbach's alpha is >0.7. Absolute reliability will be determined by calculating the standard error of measurement (SEM) to ensure the accuracy of the measurement. The SEM will be used to calculate the smallest detectable change at the 95% confidence level (MDC95) and will be calculated as: MDC95=SEM × 1.95 × √2. In all statistics, the "p" significance value will be taken as 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 40 years and older,
- Radiological and clinical diagnosis of knee OA,
- Volunteering to participate in the study,
- Ability to read and write
Key exclusion criteria (5 listed)
- Having problems with cooperation or cognitive impairment,
- Previous total knee arthroplasty surgery,
- Presence of neurodegenerative or neuromuscular disease,
- Psychological disorders,
- Presence of depression
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
Health Status Questionnaire (Short Form-SF-36)
Time frame: Evaluation data will be collected within six month.
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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Evaluation data will be collected within six month.
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.
Short Form 12-Item (SF-12) Health Survey
Time frame: Evaluation data will be collected within six month.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Meltem Meran Çağlar study chair
Medipol 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 Knee Osteoarthritis and Quality of Life, run by Meltem Meran Çağlar 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 5 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meltem Meran Çağlar (05412210058, meltem.meran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status Questionnaire (Short Form-SF-36) (time frame: Evaluation data will be collected within six month.). The study lists 3 primary outcomes in all. 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 22 Aug 2023.