Translation and Cross -Cultural Validation of ECOS-16 Questionnaire in Urdu Language

NCT04873960 | Completed

• 1 other identifier: REC/Lhr/21/1102/A Saima Riaz
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Osteopenia is a clinical term to define the declined Bone Mineral Density (BMD) as per the normal reference values but not low enough to meet osteoporotic diagnostic criteria. A Dual-energy x-ray absorptiometry (DXA) bone scan is used to diagnose decreased BMD. Osteopenia is, as described by the World Health Organization (WHO), a score ranging from -1 to -2.5, whereas Osteoporosis is diagnosed with values less than - 2.5. The risk of a decrease in BMD doubles as a woman goes into Menopause. The objective of this study will be to determine the effects of Kinect-based virtual reality training on BMD, fracture risk, physical function and Quality of life in postmenopausal women with Osteopenia. The aim of the present study is to translate the ECOS-16 Questionnaire into Urdu Language along with validation of the translated versions by evaluating its validity and reliability in the Postmenopausal women of Pakistan with Osteopenia or Osteoporosis and understanding Urdu Language. No such study has been previously conducted in the Pakistan region which translates the specific questionnaire and follows the proper cross-culture adaptation protocol.

Conditions

Postmenopausal Osteopenia; Quality of Life; Validity; Reliability; Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• ECOS-16 Quality of Life Questionnaire

  ECOS-16 evaluates the quality of life in postmenopausal women with osteoporosis. It is a brief, straightforward, self-administered questionnaire containing 16 easy-to-score items. The 16 items are further divided into four subscales: pain (5 items), physical functioning (5 items), illness-related fear (2 items), and psychosocial functioning (4 items). Each question related to these items has five response options, ranging from 1 to 5, where 5 represents the worst quality of life score. ECOS-16 provides both subscale domain scores and an overall score. Its translation is to be done in the local languages of Pakistan through a rigorous and approved process.

  6 Months

Secondary Outcomes (2)

• Reliability of Urdu translated version

  6 Months

• Validity of Urdu Translated version

  6 Months

Eligibility Criteria

• Age: 48 Years - 70 Years
• Gender Eligibility Details: Postmenopausal women with Osteoporosis or Osteopenia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postmenopausal women diagnosed with Osteoporosis and Osteopenia , clinically stable, between age 48-70 years and able to read and complete the Urdu version of ECOS-16 Questionnaire. Women having any condition mentioned in exclusion criteria will not be included in the study.

You may qualify if:

• Postmenopausal women who can speak and understand the Urdu language
• Osteopenic with Lumbar spine or femur T-score between -1 to -2.5
• Osteoporotic with Lumbar spine or femur T-score less than -2.5.

You may not qualify if:

• Impairment of communicative and sensorial functions
• Impaired Cognition
• Unstable angina
• disease requiring oxygen therapy and Symptomatic orthostatic hypotension
• Hypertension in poor pharmacologic control (diastolic \>95 mmHg, systolic \>160 mmHg)
• Neurological disorders

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Saima Riaz

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

• Badia X, Diez-Perez A, Lahoz R, Lizan L, Nogues X, Iborra J. The ECOS-16 questionnaire for the evaluation of health related quality of life in post-menopausal women with osteoporosis. Health Qual Life Outcomes. 2004 Aug 3;2:41. doi: 10.1186/1477-7525-2-41.

  PMID: 15291959 BACKGROUND

• Salaffi F, Malavolta N, Cimmino MA, Di Matteo L, Scendoni P, Carotti M, Stancati A, Mule R, Frigato M, Gutierrez M, Grassi W; Italian Multicentre Osteoporotic Fracture (IMOF) Study Group. Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis. Clin Exp Rheumatol. 2007 May-Jun;25(3):390-403.

  PMID: 17631735 BACKGROUND

• Abourazzak FE, Allali F, Rostom S, Hmamouchi I, Ichchou L, El Mansouri L, Bennani L, Khazzani H, Abouqal R, Hajjaj-Hassouni N. Factors influencing quality of life in Moroccan postmenopausal women with osteoporotic vertebral fracture assessed by ECOS 16 questionnaire. Health Qual Life Outcomes. 2009 Mar 13;7:23. doi: 10.1186/1477-7525-7-23.

  PMID: 19284667 BACKGROUND

• Moradzadeh R, Moghimi N, Nadrian H, Behrouzi F, Keshavarz T, Golmohammadi P. Validity and reliability of the Farsi version of the ECOS-16 questionnaire for females with osteoporosis. East Mediterr Health J. 2018 Jan 2;23(11):729-733. doi: 10.26719/2017.23.11.729.

  PMID: 29319144 BACKGROUND

• Lee JS, Son SM, Goh TS, Kim TH, Noh EY. Validation of the ECOS-16 Questionnaire in Koreans with Osteoporosis. Asian Spine J. 2016 Oct;10(5):877-885. doi: 10.4184/asj.2016.10.5.877. Epub 2016 Oct 17.

  PMID: 27790315 BACKGROUND

• Madureira MM, Ciconelli RM, Pereira RM. Quality of life measurements in patients with osteoporosis and fractures. Clinics (Sao Paulo). 2012 Nov;67(11):1315-20. doi: 10.6061/clinics/2012(11)16.

  PMID: 23184210 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Syed Shakil Ur Rehman, PhD

  Riphah International University

  STUDY CHAIR

• Saima Riaz, PhD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 5, 2021
• Study Start: March 15, 2021
• Primary Completion: March 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)