Clinical Validation of a Self-questionnaire in Adults With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Concordance between the results of the self-questionnaire compared to those obtained by a family tree.
研究概览
简要总结
Osteoporosis is a multifactorial disease in which genetic predispositions play a key role in its development. A better understanding of family history and clinical manifestations among first- and second-degree relatives can help improve early detection and personalized care for at-risk patients. To this end, we will test a self-administered questionnaire previously developed by our research team. This questionnaire includes the main manifestations associated with rare genetic bone diseases such as osteogenesis imperfecta, hypophosphatasia, and osteopetrosis.
详细描述
The main objective of this project is to test the validity of this new self-administered questionnaire, by studying the concordance between its answers and those obtained from a patient's family tree by telephone.
Primary Objective: To test the validity of a self-administered questionnaire to facilitate the identification of rare genetic bone diseases in adults with osteoporosis.
Secondary Objectives: To adapt the self-administered questionnaire to increase the accuracy of responses compared to those obtained using a family tree, with the aim of using it for clinical screening of rare genetic bone diseases in adults.
Data collection:
Sociodemographic data (age, sex, ethnicity, body mass index, menopausal status, smoking, alcohol consumption, physical activity, history of falls in the past year) and clinical data will be collected from participants' electronic medical records at the CHU de Québec-Université Laval (age at osteoporosis diagnosis, history of osteoporotic fractures, osteoporosis risk category based on the most recent bone density scan, calcium and/or vitamin D supplement use, history of anti-osteoporosis medications, presence of comorbidities, use of prednisone or antihormonal medications) to describe the participants and the severity of their osteoporosis. Other data collection will be conducted in two stages. First, recruited patients will be randomized to either begin with the self-administered questionnaire or the family tree. Then, 3 months later, the people who started with the questionnaire will be able to do the interview for the family tree and vice versa.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult over 18
- •Followed by the rheumatology or endocrinology clinics at the CHUL (CHU de Quebec-Universite Laval)
- •Suffer from osteoporosis
- •Have internet access
排除标准
- •Unfit, unable to consent, unable to answer a questionnaire, unknown family history (e.g. adopted person)
研究组 & 干预措施
Group starting with the self-administered questionnaire followed by the family tree and vice versa
Recruited patients will be randomized to either start with the self-administered questionnaire or the family tree. Then, 3 months later, those who started with the questionnaire will be able to do the interview for the family tree and vice versa.
干预措施: Self-administered questionnaire (Other)
Group starting with the self-administered questionnaire followed by the family tree and vice versa
Recruited patients will be randomized to either start with the self-administered questionnaire or the family tree. Then, 3 months later, those who started with the questionnaire will be able to do the interview for the family tree and vice versa.
干预措施: Family tree (Other)
结局指标
主要结局
Concordance between the results of the self-questionnaire compared to those obtained by a family tree.
时间窗: 3 months
Descriptive statistics will first be performed to characterize the participants (age, sex, number of first- and second-degree relatives, as well as the clinical manifestations detailed in the self-administered questionnaire) and to report, based on the relationship, the frequency of different clinical manifestations in relatives. In this study, the pedigree will serve as the gold standard for describing the presence or absence of familial bone disease, specifying the degree of affected kinship, the type of inheritance, and the most likely diagnosis (e.g., hypophosphatasia, osteogenesis imperfecta, etc.). The concordance between the responses provided by the self-administered questionnaire and the information from the pedigree will be primarily assessed by calculating the kappa coefficient. This analysis will constitute the main statistical approach of the study.
次要结局
未报告次要终点