NCT04044482

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

1.4 years

First QC Date

July 24, 2019

Last Update Submit

August 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Both sex, above 18 years old

You may qualify if:

  • 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.

You may not qualify if:

  • age under 18 years
  • other type of OA osteoarthritis
  • psychiatric disorders
  • surgeries within 1 month
  • incapable of filling out the forms/tools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

August 5, 2019

Study Start

July 1, 2016

Primary Completion

November 30, 2017

Study Completion

January 31, 2018

Last Updated

August 5, 2019

Record last verified: 2019-08