- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04736641
Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire
May 1, 2021 updated by: Halime ARIKAN, Gazi University
The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
There are a number of medical assessment tools for various diseases, but in most cases such tools are designed to reflect the perspective of healthcare providers, not perspective of patients.
In addition to clinical results, it is necessary to evaluate the quality of life of patients when measuring the effect of medical treatments.
Thus, evaluation criteria which can be useful as patient-reported outcome indices, have received increasing attention in recent years.
Health-related quality of life provides a patient-reported assessment.
Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ) evaluates quality of life related to hip disorders.
It is also a guide in determining the expectations of individuals in the treatment process.
It consists of 3 subscales (pain, movement and mental) and 20 items.
Hip condition and pain are evaluated with a 100 mm scale.
20 items are scaled likert with values between 0 and 4. "0" means "strongly agree", "1" means "agree", "2" means "uncertain", "3" means "disagree" and "4" means "strongly disagree".
The study is planned with 105 individuals with hip disease.
After questioning the sociodemographic characteristics of the individuals, the patients will be asked to fill in JOAHDEQ, Oxford Hip Score, International Hip Outcome Tool-12, Short Form-36, and Visual Analog Scale Test-retest will be re-applied to those of the same individuals who can be reached after 1 week.
The results will be analyzed using the SPSS version 22.0 computer package program.
Study Type
Observational
Enrollment (Anticipated)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halime ARIKAN, MSc.
- Phone Number: 05465765132
- Email: halimearikan92@gmail.com
Study Locations
-
-
None Selected
-
Ankara, None Selected, Turkey, 06490
- Recruiting
- Halime ARIKAN
-
Contact:
- Halime ARIKAN
- Email: halimearikan92@gmail.com
-
-
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study population will consist of individuals with hip disease and chronic pain on hip.
Description
Inclusion Criteria:
- Any diagnosed hip disease,
- Chronic hip pain,
- History of pain when lying or during weight-bearing activities, aggravated by activity for more than 3 months.
Exclusion Criteria:
- Lumbar spine nerve root findings,
- History of lumbar spine or hip surgery,
- Corticosteroid injection to hip in the past 3 months.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients group
Individuals with hip disease and chronic pain on hip
|
Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ) will be applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ)
Time Frame: 15 minutes
|
Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire is designed to evaluate quality of life related to hip disorders.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
March 1, 2021
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
January 30, 2021
First Submitted That Met QC Criteria
January 30, 2021
First Posted (Actual)
February 3, 2021
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
May 1, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 26.01.2021-E.13996
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- CSR
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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