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临床试验/NCT04456270
NCT04456270已完成不适用

Asthma Control in a Dutch Primary Care Population

General Practitioners Research Institute1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2020年10月1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
222
试验地点
1
主要终点
Asthma Control Questionnaire

研究概览

简要总结

Rationale: Despite the availability of effective treatment to reach symptom control, nearly half of the asthma patients remain inadequately controlled. There is a need for timely and appropriate treatment of patients with uncontrolled asthma. Improving asthma control could be achieved by a better identification of causes followed by remediating modifiable factors in primary care or referral to secondary care. However, major gaps in evidence-based asthma practice exist in primary care. So far, there is a lack of knowledge on the prevalence of inadequate asthma and associated characteristics.

Objective: The primary objective is to determine the proportion of primary care patients with inadequate asthma control, as assessed during a regular control consultation with the general practice nurse.

Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting. The AsthmaOptimiser tool will be used during regular asthma consultations in primary care, which the healthcare provider will fill in together with the patient. The AsthmaOptimiser tool creates an overview of factors and characteristics that may be associated with uncontrolled asthma, and subsequently provides a guideline-based management suggestion. Additionally, we will perform qualitative interviews to collect experiences and perspectives of healthcare providers on their use of the AsthmaOptimiser tool, including, but not limited to, ease of use, points of improvement, and on their implementation of the management suggestions.

Study population: Patients diagnosed with asthma, who attend a pre-planned primary care asthma review, are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

Main study parameters/endpoints: The primary endpoint is the proportion of patients with inadequate asthma control. Inadequate asthma control will be defined as an exacerbation in the past 4 weeks and/or an ACQ6 (i.e., Asthma Control Questionnaire) score >0.75.

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

入选标准

  • Aged ≥ 18 years
  • Physician diagnosis of Asthma
  • Capacity to provide written informed consent

排除标准

  • Life expectancy of less than 1 year
  • Inability to understand Dutch
  • Any other condition which, at the GPs and/or investigator's discretion, is believed to present a safety risk or may impact the study results
  • Patients participating in a clinical trial that may distort outcomes in this observational study.

结局指标

主要结局

Asthma Control Questionnaire

时间窗: week prior to visit to general practice nurse for check-up appointment

self-reported assessment of asthma symptoms

次要结局

未报告次要终点

研究者

发起方
General Practitioners Research Institute
申办方类型
Network
责任方
Sponsor

研究点 (1)

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