Study Stopped
Except in compulsory cases hospital admissions have been decreased significantly due to the pandemic. The study was terminated due to significant decrease in enrollment rate.
Validation of the Turkish Version of QUALEFFO-31
1 other identifier
observational
111
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2020
CompletedFirst Posted
Study publicly available on registry
February 6, 2020
CompletedStudy Start
First participant enrolled
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedMarch 11, 2021
March 1, 2021
12 months
February 2, 2020
March 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Study Arms (1)
QUALITY OF LIFE QUESTIONNAIRES
The group is anticipated to consist of 150 female and male with osteoporosis, osteopenia or normal bone mineral density.
Interventions
Administer the questionnaires to 150 participants to classify their status of quality of life.
Eligibility Criteria
Females and males aged 50 and older with osteoporosis, osteopenia or normal bone mineral density.
You may qualify if:
- 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.
You may not qualify if:
- To have malignancy.
- To have inflammatory diseases.
- To have a metabolic bone disease other than osteoporosis.
- To have neuromuscular diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bugra Incelead
Study Sites (1)
Bezmialem Vakif University Hospital
Istanbul, Turkey (Türkiye)
Related Publications (3)
van Schoor NM, Knol DL, Glas CA, Ostelo RW, Leplege 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. doi: 10.1007/s00198-005-0024-7. Epub 2005 Dec 14.
PMID: 16362146BACKGROUNDLips 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. doi: 10.1007/s001980050210.
PMID: 10501796BACKGROUNDInce B, Kucukakkas O. The reliability and validity of the Turkish version of the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31 (QUALEFFO-31). Arch Osteoporos. 2021 Sep 9;16(1):128. doi: 10.1007/s11657-021-00997-4.
PMID: 34499238DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bugra Ince, MD
Bezmialem Vakif University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Doctor, Principal Investigator
Study Record Dates
First Submitted
February 2, 2020
First Posted
February 6, 2020
Study Start
February 13, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
March 11, 2021
Record last verified: 2021-03