Adaptation and Validation of the Arabic Version of EuroQo... | NCT03504384

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

NCT03504384

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 20, 2018Actual

Enrollment

160Estimated

Phase

Not provided

Conditions

Validation Study

Interventions

questionnaire

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Estimated

Primary Completion Date

May 1, 2019Estimated

Completion Date

Jun 1, 2019Estimated

First Submitted Date

Apr 12, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2018

Last Update Posted Date

Apr 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
A reliable and validated Arabic version of the EQ-5D-5L instrument	Cross cultural adaptation and validation of the Arabic version of the EQ-5D-5L.	basline

Secondary Outcomes

Measure	Description	Time Frame
factors affecting quality of life of spine disease patients.	to study factors affecting quality of life of spine disease patients.	baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

between 18 and 70 years old. patients operated upon for spine degenerative disease coming for follow up in the outpatient clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Mahmoud Ahmed	Contact	+201024608017		drahmed.mahmoud@yahoo.com
Ahmed Shawky Abdelgawaad, Dr	Contact	+20100212222		ahsh313@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10109801	Background	EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
8263569	Background	Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms