Validation of the Turkish Version of Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31)

Validation of the Turkish Version of QUALEFFO-31

Sponsors

Lead sponsor: Bugra Ince

Source Bezmialem Vakif University
Brief Summary

The aim of this study is to investigate the adaptation and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 in patients with osteoporosis. Thus, to present a scale that will help us analyze the psychometric properties of patients with osteoporosis to the use of the Turkish people .

Detailed Description

Osteoporosis has become an important public health problem due to low bone mass, decreased bone strength and increased risk of fractures. Today, the measurement of quality of life plays an important role in the approach to diseases. Quality of Life Questionnaire of the European Foundation for Osteoporosis-41 (QUALEFFO-41) has been used for many years as a well-established and fully self-administered questionnaire. In the following years, a shorter and more practical version was needed because the QUALEFFO-41 contains many questions and takes a long time. For this reason, the questionnaire was updated in 2006 and the version of QUALEFFO-31 was made and the validity of the current questionnaire was shown. The aim of this study is to conduct the reliability and validity study of Turkish version of QUALEFFO-31 and to evaluate the power of the questionnaire to distinguish patients with osteoporosis.

Overall Status Recruiting
Start Date February 13, 2020
Completion Date September 5, 2020
Primary Completion Date August 5, 2020
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 Through study completion, an average of 6 months
Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36. Through study completion, an average of 6 months
Testing Short Form-36 Through study completion, an average of 6 months
Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 Through study completion, an average of 6 months
Enrollment 150
Condition
Intervention

Intervention type: Other

Intervention name: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)

Description: Administer the questionnaires to 150 participants to classify their status of quality of life.

Arm group label: QUALITY OF LIFE QUESTIONNAIRES

Other name: Testing the Short Form-36 (SF-36)

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- To have Dual-energy X-ray absorptiometry (DXA) results and thoracolumbar lateral spine X-Rays taken for any reason in the last 6 months.

- To have calcium, phosphorus, parathormone (PTH) and 25-hydroxyvitamin D level in the last 3 months.

- To be independently ambulatory.

- To have a cognitive capacity to understand and complete the questionnaires.

Exclusion Criteria:

- To have malignancy.

- To have inflammatory diseases.

- To have a metabolic bone disease other than osteoporosis.

- To have neuromuscular diseases.

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Bugra Ince, MD Principal Investigator Bezmialem Vakif University Hospital
Overall Contact

Last name: Bugra Ince, MD

Phone: +905358187951

Email: [email protected]

Location
facility status contact investigator
Bezmialem Vakif University Hospital Recruiting Bugra Ince, MD +905358187951 [email protected] Okan Kucukakkas, MD Principal Investigator
Location Countries

Turkey

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Bezmialem Vakif University

Investigator full name: Bugra Ince

Investigator title: Medical Doctor, Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: QUALITY OF LIFE QUESTIONNAIRES

Description: The group is anticipated to consist of 150 female and male with osteoporosis, osteopenia or normal bone mineral density.

Patient Data Undecided
Study Design Info

Observational model: Case-Only

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov