xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06004024</url>
    </required_header>
    <id_info>
      <org_study_id>MedipolU</org_study_id>
      <nct_id>NCT06004024</nct_id>
    </id_info>
    <brief_title>Psychometric Properties of the Short Form 12-item (SF-12) Health Questionnaire in Individuals With Knee Osteoarthritis</brief_title>
    <acronym>SF-12</acronym>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Meltem Meran Çağlar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beykoz University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Knee Osteoarthritis (OA) is one of the most common joint diseases with chronic low-severity&#xD;
        inflammation. 80% of individuals with knee OA have limited movements; It was found that 25%&#xD;
        of them could not do their daily work. In addition, it has been shown that the quality of&#xD;
        life of individuals with OA is lower compared to healthy individuals. This showed that&#xD;
        measuring and reporting quality of life should be mandatory in clinical studies conducted in&#xD;
        individuals with knee OA. It was stated that the most frequently used general scales in the&#xD;
        evaluation of quality of life in these individuals were SF-36 or SF-12. It takes a long time&#xD;
        for the SF-36 to be filled by individuals, which creates a disadvantage for both patients and&#xD;
        clinicians. Developed as a shorter alternative to SF-36, SF-12 has also been shown to give&#xD;
        similar results to SF-36 in individuals with knee OA who have undergone total knee&#xD;
        arthroplasty. However, the psychometric properties of SF-12 in individuals with knee OA have&#xD;
        not been examined. The purpose of this study is to examine whether SF-12 is valid and&#xD;
        reliable in individuals with knee OA and to determine the minimum detectable change (MDC)&#xD;
        value.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Forty volunteers aged 40 years and older diagnosed with knee OA will be included in the&#xD;
        study. First, individuals will be informed about the study in detail, and signed informed&#xD;
        consent form will be obtained from individuals who agree to participate in the study. First&#xD;
        of all, the demographic information of the individuals will be recorded. Chronic diseases and&#xD;
        continuous drug use will be questioned. Individuals' quality of life will be evaluated with&#xD;
        the SF-12 and SF-36 scales, and their functional status will be evaluated with the WOMAC&#xD;
        score. All scales will be filled once, but the second evaluation for the test-retest&#xD;
        reliability (intra-rater reliability) of the SF-12 scale will be repeated one week later. In&#xD;
        our study, the sample size was determined by using a web-based sample size calculation&#xD;
        application specially developed for reliability-validity studies. In this application,&#xD;
        hypothesis testing was performed according to ICC values. The minimum acceptable reliability&#xD;
        (ICC) was 0.65 and the expected reliability from the study was 0.85. When the significance&#xD;
        level of the study (α) was determined as 0.05 and the power of the study (1-β) was determined&#xD;
        as 80%, and considering the probability that 10% of the individuals participating in the&#xD;
        study could exit the study, it was found that the minimum sample size to be taken for the&#xD;
        study should be 40 people. Jamovi 2.3.28 program will be used in the statistical analysis of&#xD;
        the data. Variables determined by measurement will be expressed as mean ± standard deviation&#xD;
        (X ± SD), percent (%) will be calculated for variables determined by counting. The normal&#xD;
        distribution will be evaluated by examining both visually (Histogram and Q-Q plots) and&#xD;
        statistical techniques (Kolmogorov Smirnov test, Skewness and Kurtosis values).&#xD;
        Criterion-releated validity of SF-12 will be evaluated by its subtype, concurrent validity,&#xD;
        and its correlation with WOMAC and SF-36 scales will be evaluated. Pearson correlation test&#xD;
        will be applied when the correlation normal distribution conditions are met, and Spearman&#xD;
        correlation test will be applied if not. Correlation coefficient level will be considered as&#xD;
        &lt;0.3 low, 0.3- 0.5 medium, &gt;0.5 strong. In the reliability test of the SF-12 scale,&#xD;
        test-re-test will be applied for the stability of the scale, and intra-class correlational&#xD;
        coefficients (ICC) will be calculated. ICC values of 0.5-0.75 will indicate moderate&#xD;
        reliability, 0.75-0.9 good reliability, and &gt;0.9 excellent reliability. In order to determine&#xD;
        the internal consistency of the scale, internal consistency coefficients (Cronbach's alpha)&#xD;
        will be calculated. It will be at an acceptable level when Cronbach's alpha is &gt;0.7. Absolute&#xD;
        reliability will be determined by calculating the standard error of measurement (SEM) to&#xD;
        ensure the accuracy of the measurement. The SEM will be used to calculate the smallest&#xD;
        detectable change at the 95% confidence level (MDC95) and will be calculated as: MDC95=SEM ×&#xD;
        1.95 × √2. In all statistics, the &quot;p&quot; significance value will be taken as 0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Health Status Questionnaire (Short Form-SF-36)</measure>
      <time_frame>Evaluation data will be collected within six month.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
      <time_frame>Evaluation data will be collected within six month.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Form 12-Item (SF-12) Health Survey</measure>
      <time_frame>Evaluation data will be collected within six month.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <condition>Quality of Life</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The research will be carried out in Aydın ARSLAN Orthopedics and Traumatology Clinic, which&#xD;
          is connected to the province of Istanbul, in individuals aged 40 and over who are diagnosed&#xD;
          with knee osteoarthritis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  40 years and older,&#xD;
  &#xD;
            -  Radiological and clinical diagnosis of knee OA,&#xD;
  &#xD;
            -  Volunteering to participate in the study,&#xD;
  &#xD;
            -  Ability to read and write&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having problems with cooperation or cognitive impairment,&#xD;
  &#xD;
            -  Previous total knee arthroplasty surgery,&#xD;
  &#xD;
            -  Presence of neurodegenerative or neuromuscular disease,&#xD;
  &#xD;
            -  Psychological disorders,&#xD;
  &#xD;
            -  Presence of depression&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Meltem Meran Çağlar</last_name>
      <role>Study Chair</role>
      <affiliation>Medipol University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Meltem Meran Çağlar</last_name>
      <phone>05412210058</phone>
      <email>meltem.meran@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Meltem Meran Çağlar</name>
        <address>
          <city>Istanbul</city>
          <state>İ̇stanbul</state>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Meltem Meran Çağlar</last_name>
        <phone>05412210058</phone>
        <email>meltem.meran@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Beykoz University</investigator_affiliation>
      <investigator_full_name>Meltem Meran Çağlar</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <keyword>SF-12</keyword>
    <keyword>knee osteoarthritis</keyword>
    <keyword>validity</keyword>
    <keyword>reliability</keyword>
    <keyword>minimal detectable change</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004024
  org study id: MedipolU
  nct id: NCT06004024
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Health Status Questionnaire (Short Form-SF-36)
  time frame: Evaluation data will be collected within six month.
  description: 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.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
  time frame: Evaluation data will be collected within six month.
  description: 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.
  measure: Short Form 12-Item (SF-12) Health Survey
  time frame: Evaluation data will be collected within six month.
  description: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meltem Meran Çağlar
  role: Study Chair
  affiliation: Medipol University
  last name: Meltem Meran Çağlar
  phone: 05412210058
  email: meltem.meran@gmail.com
  facility: 
  contact: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Beykoz University
  investigator full name: Meltem Meran Çağlar
  investigator title: lecturer
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No