跳至主要内容
临床试验/NCT04259099
NCT04259099终止不适用

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

Bugra Ince1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2020年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
111
试验地点
1
主要终点
Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31

研究概览

简要总结

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 .

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • To have malignancy.
  • To have inflammatory diseases.
  • To have a metabolic bone disease other than osteoporosis.
  • To have neuromuscular diseases.

结局指标

主要结局

Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31

时间窗: 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

时间窗: 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.

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Bugra Ince
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bugra Ince

Medical Doctor, Principal Investigator

Bezmialem Vakif University

研究点 (1)

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