Knee OsteoarthritisMini-OAKHQoLNCT04587232
Turkish Version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire, Nottingham Health Profile and Short form 36
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2017to 30 Apr 2020
- How long will I take part?
- 2 Weeks
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with uni-or bilateral symptomatic knee or hip OA from the Rheumatology Division of Physical Medicine and Rehabilitation Department, Marmara University Faculty of Medicine, with the age between 18-75 years were included.
Who may be able to join
- symptomatic knee or hip OA
- between 18-75 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation of the Mini Osteoarthritis Knee and Hip Quality of Life (Mini-OAKHQoL) Questionnaire in Turkish Population
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire, Nottingham Health Profile, Short form 36, Western Ontario and McMaster
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life QuestionnaireDiagnostic 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 ProfileDiagnostic 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 36Diagnostic 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 McMasterDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL)
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.
Measured: 0 day
Secondary outcomes (3)
test-retest reliability
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.
Measured: 14 days
internal consistency
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.
Measured: 0 day
correlations for construct validity
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.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start14 Oct 2017
- Primary completion20 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Tuncay Duruöz, Professor, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587232
- Sponsor's protocol ID
- 09.2017.493
- Acronym
- Mini-OAKHQoL
- Status last verified
- Oct 2020
- First submitted
- 7 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guillemin F, Rat AC, Goetz C, Spitz E, Pouchot J, Coste J. The Mini-OAKHQOL for knee and hip osteoarthritis quality of life was obtained following recent shortening guidelines. J Clin Epidemiol. 2016 Jan;69:70-8. doi: 10.1016/j.jclinepi.2015.06.010. Epub 2015 Jun 22.
PubMed 26111768Gonzalez Saenz de Tejada M, Bilbao A, Herrera C, Garcia L, Sarasqueta C, Escobar A. Validation of the Mini-OAKHQOL for use in patients with osteoarthritis in Spain. Clin Rheumatol. 2017 Aug;36(8):1855-1864. doi: 10.1007/s10067-017-3611-z. Epub 2017 Mar 28.
PubMed 28353088
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of the Mini Osteoarthritis Knee and Hip Quality of Life (Mini-OAKHQoL) Questionnaire in Turkish Population
- ClinicalTrials.gov ID
- NCT04587232
- Acronym / sponsor ID
- Mini-OAKHQoL / 09.2017.493
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 14 Oct 2020 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with uni-or bilateral symptomatic knee or hip OA from the Rheumatology Division of Physical Medicine and Rehabilitation Department, Marmara University Faculty of Medicine, with the age between 18-75 years were included.
Key inclusion criteria (2 listed)
- symptomatic knee or hip OA
- between 18-75 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life QuestionnaireTurkish 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. | Diagnostic test | – |
| Nottingham Health ProfileStandardized 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. | Diagnostic test | – |
| Short form 36Standardized 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. | Diagnostic test | – |
| Western Ontario and McMasterStandardized 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. | Diagnostic test | – |
Primary outcome
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.
3 secondary outcomes
test-retest reliability
Time frame: 14 days
internal consistency
Time frame: 0 day
correlations for construct validity
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 26111768Guillemin F, Rat AC, Goetz C, Spitz E, Pouchot J, Coste J. The Mini-OAKHQOL for knee and hip osteoarthritis quality of life was obtained following recent shortening guidelines. J Clin Epidemiol. 2016 Jan;69:70-8. doi: 10.1016/j.jclinepi.2015.06.010. Epub 2015 Jun 22.
- Background: PubMed 28353088Gonzalez Saenz de Tejada M, Bilbao A, Herrera C, Garcia L, Sarasqueta C, Escobar A. Validation of the Mini-OAKHQOL for use in patients with osteoarthritis in Spain. Clin Rheumatol. 2017 Aug;36(8):1855-1864. doi: 10.1007/s10067-017-3611-z. Epub 2017 Mar 28.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Tuncay Duruöz, Professor study director
Marmara 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 Hip Osteoarthritis, run by Marmara University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL) (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587232, which also lists 2 linked publications.
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 19 Oct 2020.