COPD AsthmaSpiro@HomeNCT05162157
Home Spirometry in Primary Care: an Implementation Study
An observational study of COPD Asthma, run by General Practitioners Research Institute at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COPD Asthma
- What is being tested?
- NuvoAir platform
- Type of treatment
- Medical device
- How many people
- 144 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Sep 2021to 28 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age ≥ 16 years
- Spirometry indication
- Able and willing to use at-home spirometry
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this 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
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
- Being tested
- NuvoAir platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuvoAir platformDevice
Nuvoair platform, consisting of a bluetooth spirometer, smartphone application and clinical portal
| Study group | Role | What they receive |
|---|---|---|
| at-home spirometry | This group performs spirometry at home with the Nuvoair spirometer Receives: Device: NuvoAir platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: 1 day: Participant will perform one spirometry session including several manoeuvres
Secondary outcomes (5)
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.)
Measured: 1 day: Participant will perform one spirometry session including several manoeuvres
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
Measured: 1 day: Participant will perform one spirometry session including several manoeuvres
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)
Measured: Immediately after completion of spirometry measurements
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)
Measured: Immediately after completion of spirometry measurements
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.
Measured: Immediately after completion of spirometry measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start27 Sep 2021
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPD AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Practitioners Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Janwillem Kocks, Principal investigator, General Practitioners Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162157
- Sponsor's protocol ID
- GPRI-21003-SPI
- Acronym
- Spiro@Home
- Status last verified
- Feb 2023
- First submitted
- 27 Sep 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31613151Weiner 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.
PubMed 28851459
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Spirometry for the Diagnosis and Monitoring of Asthma and COPD in Primary Care in The Netherlands and Sweden: an Implementation Study
- ClinicalTrials.gov ID
- NCT05162157
- Acronym / sponsor ID
- Spiro@Home / GPRI-21003-SPI
- Conditions
- COPD Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- General Practitioners Research InstituteResearch network
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| at-home spirometry | – | Device: NuvoAir platformThis group performs spirometry at home with the Nuvoair spirometer |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 16 years
- Spirometry indication
- Able and willing to use at-home spirometry
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuvoAir platformNuvoair platform, consisting of a bluetooth spirometer, smartphone application and clinical portal | Device | at-home spirometry |
Primary outcome
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.)
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.)
5 secondary outcomes
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 curves as scored by independent spirometry professionals
Time frame: 1 day: Participant will perform one spirometry session including several manoeuvres
Healthcare professional's view on the added value of home spirometry
Time frame: Immediately after completion of spirometry measurements
Patient's view on the added value of home spirometry
Time frame: Immediately after completion of spirometry measurements
Degree of feasibility of home spirometry as rated by the healthcare professional
Time frame: Immediately after completion of spirometry measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 31613151Graham 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.
- Background: PubMed 28851459Weiner 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janwillem Kocks principal investigator
General Practitioners Research Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Asthma, run by General Practitioners Research Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful spirometry (time frame: 1 day: Participant will perform one spirometry session including several manoeuvres). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.