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临床试验/NCT06659666
NCT06659666已完成不适用

Opportunities to Optimize COPD Management Using the COPD Optimiser Online Tool in Dutch General Practice

General Practitioners Research Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月9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
100
试验地点
2
主要终点
patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD.

研究概览

简要总结

Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Despite the availability of these COPD treatment guidelines, evidence suggests that available thera- pies may not be utilized to their full potential to optimize disease management and outcomes for patients. So far, there is a lack of knowledge on the optimalisation opportunities of patients with COPD in a primary care setting.

Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.

Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.

Study population: Patients diagnosed with COPD 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.

ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.

Primary objective

1. Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Physician diagnosis of COPD (ICPC R95),
  • Capacity to understand and provide written informed consent.

排除标准

  • Active diagnosis of Asthma (ICPC R96)
  • Patients participating in an interventional clinical trial

结局指标

主要结局

patterns of co-occurrence of GOLD-guided management suggestions in a Dutch primary care population of patients with COPD.

时间窗: Immediately after the procedure

The primary endpoint is the number of times that each management suggestion was given. With this endpoint, we can describe the proportion of primary care patients with COPD of whom disease management can be optimized per GOLD-guided management suggestions from the COPD Optimiser. Incidence will be described for each of the possible management suggestions from the COPD Optimiser.

次要结局

  • Co-occurance and concordance of GOLD-based management suggestions(Immediately after the procedure)

研究者

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

研究点 (2)

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