Home Spirometry in Primary Care: an Implementation Study

COPD Asthma Clinical Trial

— Spiro@Home  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162157
• Other study ID #: GPRI-21003-SPI
• Status: Completed
• Start date: September 27, 2021
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2023
• Source: General Practitioners Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asthma
• COPD Asthma

Intervention

Device:
• NuvoAir platform
Nuvoair platform, consisting of a bluetooth spirometer, smartphone application and clinical portal

Locations

Country	Name	City	State
Netherlands	GPRI	Groningen
Sweden	Karolinska Institute	Solna	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
General Practitioners Research Institute

Countries where clinical trial is conducted

Netherlands,  Sweden, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Agreement between Forced Expiratory Volume in the first second (FEV1) obtained from home spirometry and from spirometry assessed 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	1 week: participant is performing one home-spirometry session and within the same week one session at the general practice
Other	Agreement between Forced Vital Capacity (FVC) obtained from home spirometry and from spirometry assessed 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	1 week: participant is performing one home-spirometry session and within the same week one session at the general practice
Other	Occurrence of patients requiring video assistance by a spirometry professional	Percentage of patients requiring assistance through a video connection with performing spirometry	1 day: Participant will perform one spirometry session including several manoeuvres
Other	Level of required assistance by a spirometry professional	Mean total time in minutes spent per patient by a spirometry professional for performing home spirometry	1 day: Participant will perform one spirometry session including several manoeuvres
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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