跳至主要内容
临床试验/NCT05739708
NCT05739708招募中不适用

Psychological Characteristics of Patients With Severe Asthma

Centre Hospitalier Universitaire de Besancon2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Description of the psychological profile of severe asthma patients

研究概览

简要总结

Like any chronic disease, asthma exposes individuals to stressful and threatening situations that require ongoing cognitive, emotional, behavioral and social adaptation. Approximately 5-10% of patients with asthma have a treatment-resistant disease, with frequent emergency room visits and hospitalizations. These patients are responsible for the majority of the overall asthma-related disease burden and also represent more than half of the total direct costs of asthma management. The scientific literature shows that personality traits, attachment type and psychological disorders will significantly influence disease coping strategies, disease experience, quality of life, adherence and therapeutic alliance. Although some data exist in asthma, there are currently no studies that have evaluated the overall psychological profile of asthma patients, and we have no data specifically on the population of severe asthmatics, who are the most difficult to manage. A better understanding of the overall psychological dimension of asthma patients will make it possible to offer therapeutic education programs that are more targeted according to the psychosocial skills of the patient and finally improve the overall management of the disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patient aged ≥ 18 years and followed in the Respiratory Department of the Besançon University Hospital for an asthmatic disease diagnosed for more than 12 months. Will be considered as severe patients, asthma patients with uncontrolled asthma despite high therapeutic pressure (GINA levels 4 and 5) and patients requiring to be controlled high doses of inhaled corticosteroids and long-acting beta-2-agonists (or anti-leukotriene/theophylline) in the past year or systemic corticosteroid therapy (>50% in the previous year) (ATS-ERS 2014 criteria).
  • Patient able to understand the objectives of the research
  • Patient who has signed a research consent form
  • Patient affiliated to a French social security system or beneficiary of such a system

排除标准

  • Patient with reading and comprehension difficulties that prevent them from completing the questionnaires
  • Motor disability that prevents the patient from completing the questionnaires
  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the the investigator
  • Subject without health insurance
  • Subject under court protection, guardianship, conservatorship, or protective supervision. protection.

研究组 & 干预措施

Asthma patients

Other

干预措施: Questionnaires (Other)

结局指标

主要结局

Description of the psychological profile of severe asthma patients

时间窗: 1 day

Score on questionnaires assessing coping strategies (ACL-F)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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