Home Spirometry in Primary Care: an Implementation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

144 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-27

Study Completion Date

2022-12-28

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.

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Detailed Description

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Conditions

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COPD Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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at-home spirometry

This group performs spirometry at home with the Nuvoair spirometer

NuvoAir platform

Intervention Type DEVICE

Nuvoair platform, consisting of a bluetooth spirometer, smartphone application and clinical portal

Interventions

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NuvoAir platform

Nuvoair platform, consisting of a bluetooth spirometer, smartphone application and clinical portal

Intervention Type DEVICE

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)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No