Home Spirometry in Primary Care: an Implementation Study

Study Overview
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Brief Summary
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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.

Official Title
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Home Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study

Conditions
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COPD Asthma

Intervention / Treatment
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* Device: NuvoAir platform


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| at-home spirometry<br>This group performs spirometry at home with the Nuvoair spirometer | Device: NuvoAir platform<br>* Nuvoair platform, consisting of a bluetooth spirometer, smartphone application and clinical portal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful spirometry | 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.) | 1 day: Participant will perform one spirometry session including several manoeuvres | 
| Clinically useful spirometry | 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.) | 1 day: Participant will perform one spirometry session including several manoeuvres | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of spirometry, following ATS/ERS grading of spirometry | Quality of spirometry performed as rated by the device application using the American Thoracic Society /European Respiratory Society (ERS) grading of spirometry on a scale from A (≥3 acceptable and repeatability within 0.150 litre) to F (zero acceptable or usable) (Graham, B. L. et al.) | 1 day: Participant will perform one spirometry session including several manoeuvres | 
| Quality of spirometry curves as scored by independent spirometry professionals | Quality as assessed by visual inspection of curves and values by two or three (in case of disagreement between the first two) independent spirometry professionals whether manoeuvres are acceptable or not | 1 day: Participant will perform one spirometry session including several manoeuvres | 
| Healthcare professional's view on the added value of home spirometry | Individual scores on a 5-points Likert-scale of questions asked to healthcare professionals regarding the added value of home spirometry for monitoring and diagnosing of asthma and COPD (the Likert-scales range from strongly disagree to strongly agree) | Immediately after completion of spirometry measurements | 
| Patient's view on the added value of home spirometry | Individual scores on a 5-points Likert-scale of questions asked to the patient on the benefit of home spirometry (the Likert-scales range from strongly disagree to strongly agree) | Immediately after completion of spirometry measurements | 
| Degree of feasibility of home spirometry as rated by the healthcare professional | Individual scores on a 5-points Likert-scale of questions on the feasibility of home spirometry, scored by health professionals, including four questions of a validated tool as published by Weiner et al. | Immediately after completion of spirometry measurements |