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Completed

NCT Number: NCT05162157

Home Spirometry in Primary Care: an Implementation Study

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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Key information

Conditions

COPD Asthma

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GPRI, Groningen, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NuvoAir platform

Device

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

Primary outcomes

  1. 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.)

  2. 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.)

Secondary outcomes

  1. Quality of spirometry, following ATS/ERS grading of spirometry

    Time frame: 1 day: Participant will perform one spirometry session including several manoeuvres

    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.)

  2. Quality of spirometry curves as scored by independent spirometry professionals

    Time frame: 1 day: Participant will perform one spirometry session including several manoeuvres

    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

  3. Healthcare professional's view on the added value of home spirometry

    Time frame: Immediately after completion of spirometry measurements

    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)

  4. Patient's view on the added value of home spirometry

    Time frame: Immediately after completion of spirometry measurements

    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)

  5. Degree of feasibility of home spirometry as rated by the healthcare professional

    Time frame: Immediately after completion of spirometry measurements

    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.

Other outcomes

  1. Agreement between Forced Expiratory Volume in the first second (FEV1) obtained from home spirometry and from spirometry assessed at the general practice

    Time frame: 1 week: participant is performing one home-spirometry session and within the same week one session at the general practice

    Mean difference (with 95% confidence interval) between the individual highest FEV1 value obtained from home spirometry and the FEV1 value from spirometry assessed at the general practice

  2. Agreement between Forced Vital Capacity (FVC) obtained from home spirometry and from spirometry assessed at the general practice

    Time frame: 1 week: participant is performing one home-spirometry session and within the same week one session at the general practice

    Mean difference (with 95% confidence interval) between the individual highest FVC value obtained from home spirometry and the FVC value from spirometry assessed at the general practice

  3. Occurrence of patients requiring video assistance by a spirometry professional

    Time frame: 1 day: Participant will perform one spirometry session including several manoeuvres

    Percentage of patients requiring assistance through a video connection with performing spirometry

  4. Level of required assistance by a spirometry professional

    Time frame: 1 day: Participant will perform one spirometry session including several manoeuvres

    Mean total time in minutes spent per patient by a spirometry professional for performing home spirometry

Sponsors and collaborators

Lead sponsor

General Practitioners Research Institute

Network

Registry information

Official study title

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

Acronym: Spiro@Home

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2021
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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