Clinical trial NCT05162157: Home Spirometry in Primary Care: an Implementation Study
Official title: Home Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD Asthma
Lead sponsor: General Practitioners Research Institute
Sponsor class: NETWORK
First posted: 2021-12-17
Enrollment: 144
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Successful spirometry
timeFrame: 1 day: Participant will perform one spirometry session including several manoeuvres
measure: Clinically useful spirometry
timeFrame: 1 day: Participant will perform one spirometry session including several manoeuvres
Secondary outcomes:
measure: Quality of spirometry, following ATS/ERS grading of spirometry
timeFrame: 1 day: Participant will perform one spirometry session including several manoeuvres
measure: Quality of spirometry curves as scored by independent spirometry professionals
timeFrame: 1 day: Participant will perform one spirometry session including several manoeuvres
measure: Healthcare professional's view on the added value of home spirometry
timeFrame: Immediately after completion of spirometry measurements
measure: Patient's view on the added value of home spirometry
timeFrame: Immediately after completion of spirometry measurements
measure: Degree of feasibility of home spirometry as rated by the healthcare professional
timeFrame: Immediately after completion of spirometry measurements
Other outcomes:
measure: Agreement between Forced Expiratory Volume in the first second (FEV1) obtained from home spirometry and from spirometry assessed at the general practice
timeFrame: 1 week: participant is performing one home-spirometry session and within the same week one session at the general practice
measure: Agreement between Forced Vital Capacity (FVC) obtained from home spirometry and from spirometry assessed at the general practice
timeFrame: 1 week: participant is performing one home-spirometry session and within the same week one session at the general practice
measure: Occurrence of patients requiring video assistance by a spirometry professional
timeFrame: 1 day: Participant will perform one spirometry session including several manoeuvres
measure: Level of required assistance by a spirometry professional
timeFrame: 1 day: Participant will perform one spirometry session including several manoeuvres
Locations:
city: Groningen
country: Netherlands
facility: GPRI
city: Solna
country: Sweden
facility: Karolinska Institute
state: Stockholm
Study officials:
affiliation: General Practitioners Research Institute
name: Janwillem Kocks
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.