Validation of the Turkish Version of QUALEFFO-31

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04259099
• Other study ID #: 54022451-050.05.04-01/16
• Status: Terminated
• Start date: February 13, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Testing 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.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bugra Ince

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Lips P, Cooper C, Agnusdei D, Caulin F, Egger P, Johnell O, Kanis JA, Kellingray S, Leplege A, Liberman UA, McCloskey E, Minne H, Reeve J, Reginster JY, Scholz M, Todd C, de Vernejoul MC, Wiklund I. Quality of life in patients with vertebral fractures: validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Working Party for Quality of Life of the European Foundation for Osteoporosis. Osteoporos Int. 1999;10(2):150-60. — View Citation

van Schoor NM, Knol DL, Glas CA, Ostelo RW, Leplège A, Cooper C, Johnell O, Lips P. Development of the Qualeffo-31, an osteoporosis-specific quality-of-life questionnaire. Osteoporos Int. 2006;17(4):543-51. Epub 2005 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability and validity of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31	Internal consistency will be tested with Cronbach Alpha coefficient. Intergroup reliability and consistency will be evaluated by T-Test.	Through study completion, an average of 6 months
Primary	Correlation between Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 and Short Form-36.	The Spearman Correlation Analysis will be used for the correlation between QUALEFFO-31 and SF-36.	Through study completion, an average of 6 months
Primary	Testing Short Form-36	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.	Through study completion, an average of 6 months
Primary	Testing Quality of Life Questionnaire of the European Foundation for Osteoporosis-31	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.	Through study completion, an average of 6 months