NCT04587232

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.5 years

First QC Date

October 7, 2020

Last Update Submit

October 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    0 day

Secondary Outcomes (3)

  • test-retest reliability

    14 days

  • internal consistency

    0 day

  • correlations for construct validity

    0 day

Interventions

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.

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.

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26111768BACKGROUND
  • Gonzalez 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.

    PMID: 28353088BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Mehmet Tuncay Duruöz, Professor

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

October 14, 2017

Primary Completion

April 20, 2020

Study Completion

April 30, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations