Home Spirometry in Primary Care: an Implementation Study

NCT05162157 | Completed

• 1 other identifier: GPRI-21003-SPI
• Study Type: observational
• Target: 144
• Locations: 2 countries
• Sites: 2

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.

Conditions

COPD Asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• 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

• Degree of feasibility of home spirometry as rated by the healthcare professional

  Immediately after completion of spirometry measurements

Other Outcomes (4)

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

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

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

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

• Occurrence of patients requiring video assistance by a spirometry professional

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

Study Arms (1)

at-home spirometry

This group performs spirometry at home with the Nuvoair spirometer

Device: NuvoAir platform

Interventions

NuvoAir platform DEVICE

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

at-home spirometry

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In principle, all patients with a spirometry indication diagnosis or monitoring of their airway disease of 16 years or older will be eligible for at-home spirometry.

You may qualify if:

• Age ≥ 16 years
• Spirometry indication
• Able and willing to use at-home spirometry

You may not qualify if:

• 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)

Sponsors & Collaborators

• General Practitioners Research Institute: lead

Study Sites (2)

GPRI

Groningen, 9713GH, Netherlands

Location

Karolinska Institute

Solna, Stockholm County, Sweden

Location

Related Publications (2)

• Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

  PMID: 31613151 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

Study Officials

• Janwillem Kocks

  General Practitioners Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 17, 2021
• Study Start: September 27, 2021
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

NL (1); SE (1)