Home Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Clinically useful spirometry
研究概览
简要总结
Rationale: Spirometry is essential in the diagnosis of airway disease and can be useful in monitoring patients. Despite the essential role, spirometry remains largely underused in primary care. Due to Coronavirus disease (COVID-19), the use of office spirometry is contraindicated in many countries. Furthermore, spirometric devices are costly and personnel requires special training. Referral for spirometry increases the cost for patients and lowers the feasibility. Part of the reason for underdiagnosis of airway disease are the specific situations (such as exercise-induced asthma) in which spirometry in office setting might not reveal abnormalities. In recent years, handheld spirometry linked to phones/apps has been developed for study purposes and remote monitoring.
Objective: To study the feasibility, quality and added value of at-home spirometry for the diagnosis and monitoring of asthma and Chronic Obstructive Pulmonary Disease (COPD) in primary care.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years
- •Spirometry indication
- •Able and willing to use at-home spirometry
排除标准
- •On the discretion of the recruiting clinician if he or she deems a patient not eligible.
- •Inability to understand and sign the informed consent form
- •Known previous inability to perform spirometry
- •Contraindications to perform spirometry as listed in the standardization of Spirometry 2019 update (Graham et al., 2019)
结局指标
主要结局
Clinically useful spirometry
时间窗: 1 day: Participant will perform one spirometry session including several manoeuvres
Occurrence (expressed as percentage of patients) of home spirometry being graded A, B or C, following technical standards of the American Thoracic Society and the European Respiratory Society (Graham, B.L. et al.)
Successful spirometry
时间窗: 1 day: Participant will perform one spirometry session including several manoeuvres
Occurrence (expressed as percentage of patients) of home spirometry being graded A, following technical standards of the American Thoracic Society (ATS) and the European Respiratory Society (ERS) (Graham, B. L. et al.)
次要结局
- Healthcare professional's view on the added value of home spirometry(Immediately after completion of spirometry measurements)
- Patient's view on the added value of home spirometry(Immediately after completion of spirometry measurements)
- Quality of spirometry, following ATS/ERS grading of spirometry(1 day: Participant will perform one spirometry session including several manoeuvres)
- Quality of spirometry curves as scored by independent spirometry professionals(1 day: Participant will perform one spirometry session including several manoeuvres)
- Degree of feasibility of home spirometry as rated by the healthcare professional(Immediately after completion of spirometry measurements)