NCT03504384

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

April 12, 2018

Last Update Submit

April 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • factors affecting quality of life of spine disease patients.

    baseline

Interventions

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • preoperative patients and immediate postoperative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 10109801BACKGROUND
  • 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.

    PMID: 8263569BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Ahmed Mahmoud Ahmed

CONTACT

Ahmed Shawky Abdelgawaad, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 20, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

April 20, 2018

Record last verified: 2018-04