Home Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD Asthma
- Sponsor
- General Practitioners Research Institute
- Enrollment
- 144
- Locations
- 2
- Primary Endpoint
- Clinically useful spirometry
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 16 years
- •Spirometry indication
- •Able and willing to use at-home spirometry
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Clinically useful spirometry
Time Frame: 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
Time Frame: 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.)
Secondary Outcomes
- 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)