Evaluation of Health Related Quality of Life and Patient Adherence in Case of Hungarian Patients Affected by Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Evaluation of Health Related Quality of Life and Patient Adherence in Case of Hungarian Patients Affected by Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044482
• Other study ID #: 24950-3/2016/EKU
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: January 31, 2018

Study information

• Verified date: August 2019
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Translation and Cross-cultural adaptation process of the Osteoarthritis Knee and Hip Quality of Life questionnaire. According to granted guidelines, shared by the developer of the questionnaire, the study was conducted among Hungarian patients affected by osteoarthrosis.

Description:

This prospective study was performed among patients diagnosed - by the doctors acting as the expert panel of this study - with OA of the lower limb. The recruitment period was: June 2017 and November 2017, in six hospitals situated in six different geographical regions of Hungary. The participating hospitals were selected in a way to represent different geographic and cultural areas of the country; the patients were selected randomly by the doctors of the given sites. The process was conducted with the contribution of: (1) Translation committee (4 members), (2) Our research team, as moderator (4 members), (3) Expert panel (6 doctors professors of the study sites: orthopaedists, rheumatologists, musculoskeletal rehabilitation doctors). The used instruments were for the validation process: Short version of World Health Organization Quality of life questionnaire (WHOQoL-BREF), EuroQuality of Life - 5-dimension questionnaire as generic quality of life measurement tools (EQ-5D - VAS). In addiction 99 patients filled the questionnaires in an appropriate way. The results were evaluated by 23.0 version of SPSS program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 31, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age over 18 years

• clinically/doctor diagnosed knee and/or hip osteoarthritis

• native Hungarian language

• ability of self-filling and completely filled patient data sheet.

Exclusion Criteria:

• age under 18 years

• other type of OA osteoarthritis

• psychiatric disorders

• surgeries within 1 month

• incapable of filling out the forms/tools

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity and Reliability of the translated and adapated questionnaire	The translated questionnaire was tested among affected patients. First of all the face and content validity were evaluated, namely how understandable is the translated questionnaire for patients with Hungarian native language. How many percent of the items were no answered. According to the shared guideline if more then 5 % of an item is not answered should be selected from the final version of the questionnaire - with the exception of the items based on sexual life(3 items). The research team noticed that face and content validity were adequate.	17 months