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Adaptation and Validation of the Arabic Version of EuroQol 5D-5L

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ClinicalTrials.gov Identifier: NCT03504384
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mahmoud Ahmed Sarhan, Assiut University

Brief Summary:

The aim of the work is to provide a validated Arabic version of EuroQol 5D-5L ,so that it would be used as a quality of life assessment tool for Egyptian patients

Specific objectives:

  1. Cross cultural adaptation of the translated Arabic version of EuroQol 5D-5L.
  2. Assessment of the reliability of the translated Arabic version of EuroQol 5D-5L.
  3. Testing the validity of the translated version of EuroQol 5D-5L.

Condition or disease Intervention/treatment
Validation Study Other: questionnaire

Detailed Description:
Chronic back pain is one of the most important disabling illnesses. It has a high incidence, high prevalence and high cost to society. One of the most common causes of back pain are degenerative spine diseases which affect all aspects of quality of life (QoL) of the patients. They could affect job opportunities, social activities and hinder the patients from performing common daily activities.It was found that many factors could affect quality of life of spine degenerative diseases patients such as sex, age, body mass index (BMI), employment status , living with other family members, smoking, orthopedic disorder in another part of the body (other than spinal disease), history of spinal surgery, and bladder function. Comprehensive assessment of these patients should include health related quality of life (HRQoL) measures in addition to the objective clinical measures of the diseases. Europeans Quality of life questionnaire 5 dimensions ,5 levels (EQ-5D-5L) is a standardized measure of health status developed by the EuroQol Group which provides a simple, generic measure of health for clinical and economic appraisal (2).Despite being translated and validated in many languages, there is no validated Arabic version of EQ-5D-5L to measure the quality of life. The objective of this study is to evaluate the reliability and validity of the Arabic version of the questionnaire for Egyptian patients diagnosed to have Spine degenerative diseases.

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Cross Cultural Adaptation and Validation of The Arabic Version Of EuroQol 5D-5L
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : June 1, 2019

Intervention Details:
  • Other: questionnaire
    All patients will be interviewed using a semi-structured questionnaire detailing patients' demographic characteristics (age, sex, education, occupation, residence), and the factors that could affect their quality of life such as pain and neurological symptoms, orthopedic disorder in another part of the body and history of spinal surgery.


Primary Outcome Measures :
  1. A reliable and validated Arabic version of the EQ-5D-5L instrument [ Time Frame: basline ]
    Cross cultural adaptation and validation of the Arabic version of the EQ-5D-5L.


Secondary Outcome Measures :
  1. factors affecting quality of life of spine disease patients. [ Time Frame: baseline ]
    to study factors affecting quality of life of spine disease patients.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
between 18 and 70 years old. patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.
Criteria

Inclusion Criteria:

  • patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Exclusion Criteria:

  • preoperative patients and immediate postoperative patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504384


Contacts
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Contact: Ahmed Mahmoud Ahmed +201024608017 drahmed.mahmoud@yahoo.com
Contact: Ahmed Shawky Abdelgawaad, Dr +20100212222 ahsh313@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Ahmed Mahmoud Ahmed Sarhan, dr, Assiut University
ClinicalTrials.gov Identifier: NCT03504384     History of Changes
Other Study ID Numbers: validation of EuroQol 5D-5L
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No