Turkish Version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL)

October 13, 2020 updated by: Marmara University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Marmara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
0 day
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.
0 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2017

Primary Completion (ACTUAL)

April 20, 2020

Study Completion (ACTUAL)

April 30, 2020

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (ACTUAL)

October 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2017.493

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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