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Completed

NCT Number: NCT04587232

Turkish Version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire

In this paper, the adaptation of the Mini-OAKHQoL questionnaire in the Turkish population analyzing the feasibility, reliability, and validity of the questionnaire was documented.

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Key information

Conditions

Knee Osteoarthritis Arthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, 34899, Turkey (Türkiye)

About this study

Knee and hip osteoarthritis are common diseases that play an important role in health-related quality of life (HR-QoL). Assessing HR-QoL with a disease- and site-specific HR-QoL is more advantageous than generic scales. In that concept, to our knowledge, there is not any osteoarthritis- and lower limb-specific HR-QoL instrument to use in Turkey. Mini-OAKHQoL was derived from the OAKHQoL questionnaire, which was developed to assess the quality of life (QoL) in subjects with lower limb osteoarthritis. Its good psychometric properties have recently been shown and validation studies have been done in several populations. Mini-OAKHQoL's validation study has not been done before in Turkey. The aim is to investigate the validity and reliability of the Turkish version of the Mini-OAKHQoL. Patients diagnosed with knee or hip osteoarthritis were recruited. For cross-cultural adaptation, items of Mini-OAKHQoL were selected from the interrelated Turkish version of the OAKHQoL study in which the adaptation process had already done. Missing data, floor effect, and ceiling effect were calculated. Reliability analysis with internal consistency and test-retest reliability were discovered. Face, content, convergent, and divergent validities were applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • symptomatic knee or hip OA
  • between 18-75 years

Exclusion criteria

  • history of inflammatory disease,
  • a disease involving cognitive deficit and psychiatric illness,
  • knee or hip surgery within one year,
  • another disease of the lower limbs

Treatment and study plan

Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire

Diagnostic Test

Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL) was derived from the Turkish version of OAKHQoL questionnaire, which was developed to assess the quality of life (QoL) in subjects with lower limb osteoarthritis. It includes five subscales: physical activities, mental health, pain, social support, social functioning; with three additional independent items addressing sexual life, professional life, and fear of being dependent. The numerical rating scales in the items range from 0 (worst) to 10 (best). Scores were obtained by computing the means of the item scores in each subscale. The last three items' score (independent items) becomes the corresponding score.

Nottingham Health Profile

Diagnostic Test

Standardized questionnaire to investigate the health-related quality of life. NHP is a general is used to measure health problems perceived by the patient. It comprises 6 sections. The sum of the items within each section ranges from 0 to 100, and the total score ranges from 0 to 600. The higher score shows a worse quality of life.

Short form 36

Diagnostic Test

Standardized questionnaire to investigate the general health-related quality of life. The SF-36 questionnaire is a generic quality of life questionnaire and consists of 8 subscales, with 36 items. The scores ranges from 0 to 100 and the high score indicates good health.

Western Ontario and McMaster

Diagnostic Test

Standardized questionnaire to investigate the health status of patients with osteoarthritis. The WOMAC OA index assesses the symptomatic severity and disability with pain, stiffness, and physical function domains. Each subscale was summated to a maximum score of 20, 8, and 68, respectively, with the higher scores corresponding worst health status.

Primary outcomes

  1. Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL)

    Time frame: 0 day

    Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL) was derived from the Turkish version of OAKHQoL questionnaire, which was developed to assess the quality of life (QoL) in subjects with lower limb osteoarthritis. It includes five subscales: physical activities, mental health, pain, social support, social functioning; with three additional independent items addressing sexual life, professional life, and fear of being dependent. It asks for the impact of the knee or hip OA on their QoL over the last month while filling the items. The numerical rating scales in the items range from 0 (worst) to 10 (best). Scores were obtained by computing the means of the item scores in each subscale. The social support and social functioning subscales are questioned inverse but scored similarly to the "0 (worst)-10 (best) concept. The last three items' score (independent items) becomes the corresponding score.

Secondary outcomes

  1. test-retest reliability

    Time frame: 14 days

    For test-retest reliability, participants were asked to refill the Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire after two weeks from the initial assessment.

  2. internal consistency

    Time frame: 0 day

    The reliability of the Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire was assessed by internal consistency using Cronbach's alpha coefficient and test-retest reliability using intraclass correlation coefficients.

  3. correlations for construct validity

    Time frame: 0 day

    Convergent and divergent validities were analyzed to determine the construct validity. Convergent validity was assessed by correlating the Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life (Mini-OAKHQoL) questionnaire score with the subsets of Nottingham Health Profile (NHP), Short form 36 (SF-36), and Western Ontario and McMaster questionnaire (WOMAC). The correlations of the Mini-OAKHQoL with parameters that are not directly related to the health-related quality of life, such as age, body mass index, and disease duration were assessed for divergent validity.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Adaptation and Validation of the Mini Osteoarthritis Knee and Hip Quality of Life (Mini-OAKHQoL) Questionnaire in Turkish Population

Acronym: Mini-OAKHQoL

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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