Validation of the Turkish Version of QUALEFFO-31

Terminated

• Conditions: Osteoporosis
• Interventions: Other: Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)

• Registration Number: NCT04259099
• Lead Sponsor: Bugra Ince

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.

Study Timeline

• Study First Submitted: 2020-02-02
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2020-02-13
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QUALITY OF LIFE QUESTIONNAIRES	Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)	The group is anticipated to consist of 150 female and male with osteoporosis, osteopenia or normal bone mineral density.

Primary Outcome Measures

Name	Time	Method
Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31	Through study completion, an average of 6 months	QUALEFFO-31 is a self-assessment instrument. It consists of three domains: pain,physical function and a mental function. QUALEFFO-31 is scored from 0 to 100. Domain scores were calculated by summing the scores of questions included in the domain and submitting the sum to a linear transformation to a scale of 100. Zero indicated good health status and 100 indicated poor health status.
Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31	Through study completion, an average of 6 months	Internal consistency will be tested with Cronbach Alpha coefficient. Intergroup reliability and consistency will be evaluated by T-Test.
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	The Spearman Correlation Analysis will be used for the correlation between QUALEFFO-31 and SF-36.
Testing Short Form-36	Through study completion, an average of 6 months	SF-36 is a self-assessment instrument. It consists of eight domains: bodily pain, physical functioning, social functioning, general health, mental health, vitality, and role restrictions due to physical and emotional problems.SF-36 is scored from 0 to 100. 0 indicated poor health status and 100 indicated good health status.

Trial Locations

Locations (1)

Bezmialem Vakif University Hospital; 🇹🇷 Istanbul, Turkey