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临床试验/NCT04029870
NCT04029870已完成不适用

Psychological déterminants of the Therapeutic Observance of Osteoporotic Patients

Centre Hospitalier Régional Metz-Thionville1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2019年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
152
试验地点
1
主要终点
Adherence to therapy

研究概览

简要总结

Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures.

On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy.

The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Be treated with an anti-osteoporotic drug for at least three months
  • Mastering the French language orally and in writing
  • Have obtained the patient's oral agreement to participate in the research
  • Present post-menopausal osteoporosis
  • Present a densitometric osteoporosis with a T-score (-2.5) treated medically per OS (example: biphosphonates) or by subcutaneous injection (example: prolia)
  • Present a history of severe osteoporotic fractures after falls of its height.

排除标准

  • Present a psychiatric history
  • Present an intellectual disability
  • Present major cognitive disorders related to neurodegenerative disease or other nervous system disorders.

结局指标

主要结局

Adherence to therapy

时间窗: Day 1

The influence of psychological emission on the therapeutic adherence is measured with an adherence scale (EGOMAC) which includes 3 items: drugs observance, hygiene compliance and dietary restrictions. The item are scored on a 4-point scale with 1-strongly disagree; 2-disagree, 3-agree and 4-fully agree.

次要结局

  • Anxiety(day 1)
  • Perception of disease(day 1)
  • Adherence to therapy(Year 1)
  • Perception of treatment(day 1)

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (1)

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