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Validation of the Turkish Version of QUALEFFO-31

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04259099
Enrollment
111
Registered
2020-02-06
Start date
2020-02-13
Completion date
2021-02-01
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, Questionnaire, Quality of Life, QUALEFFO

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.

Interventions

OTHERTesting the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)

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

Sponsors

Bugra Ince
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36.Through study completion, an average of 6 monthsThe Spearman Correlation Analysis will be used for the correlation between QUALEFFO-31 and SF-36.
Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31Through study completion, an average of 6 monthsInternal consistency will be tested with Cronbach Alpha coefficient. Intergroup reliability and consistency will be evaluated by T-Test.
Testing Short Form-36Through study completion, an average of 6 monthsSF-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.
Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31Through study completion, an average of 6 monthsQUALEFFO-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026