COPDNCT03206606
Evaluation of a Mobile Application to Facilitate the Interpretation of Spirometry by Family Physicians and Residents
An observational study of COPD and Spirometry, run by Laval University at 8 sites in Canada.
Trial summary
Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic obstructive pulmonary disease (COPD). However, this test remains underused in the primary care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Spirometry, Mobile Application
- What is being tested?
- SPIRO
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- 8 sitesCanada
- Study dates
- 1 Oct 2016to 20 Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care physicians and residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.
Who may be able to join
- Participants need to be primary care physicians or residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.
Who cannot join
- Health professionals not practicing family medicine and residents of other specialties will not be eligible. Individuals who participated in the development of the " subjective Norms, Attitudes, Perceived behavioral control, Intentions (NAPI) " questionnaires (apparent validation) will be excluded.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
UMF de Manicouagan
Baie-Comeau, Quebec, G4Z 3B8
UMF de Gaspé
Gaspé, Quebec, G4X 2W2
UMF des Etchemins
Lac-Etchemin, Quebec, G0R 1S0
UMF de Lévis
Lévis, Quebec, G6W 0J4
Unité de médecine familiale - GMF Maizerets
Québec, Quebec, G1J 2G1
UMF Saint-François d'Assise
Québec, Quebec, G1L 3L5
Unité de médecine familiale Laval
Québec, Quebec, G1V 0B7
UMF de Trois-Pistoles
Trois Pistoles, Quebec, G0L 4K0
About this study
Official title: Evaluation of a Mobile Application to Facilitate the Interpretation of the Spirometry Test by Family Physicians and Family Medicine Residents: Impact on Prescription and Interpretation of This Test
Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic obstructive pulmonary disease (COPD). However, this test remains underused in the primary care. The tools available for its interpretation are little used and the existence of several decision algorithms can create confusion during the diagnosis.
Principal objective: To evaluate the impact of a mobile application (SPIRO©) on medical practice (interpretation and prescription of spirometry) of family physicians and family medicine residents working in family medicine units (FMU) in Quebec affiliated with Laval University.
Read more
Secondary objective : To evaluate the usability of SPIRO© among family physicians and residents in family medicine working in FMU in Quebec affiliated with Laval University.
Methods: This is a pre-post clinical trial with control group. Participants (family MD and family medicine residents) will be recruited from the various FMU affiliated with Laval University. Participants working in the FMU in the experimental group will be able to use the SPIRO® mobile application to facilitate interpretation of the spirometry test results while participants in the control group will not have access to it during the study. The basic characteristics of the participants and various behavioral parameters based on the theory of planned behavior concerning the interpretation and prescription of spirometry test will be measured. Data from the control group will be collected before those in the experimental group at the time the application is not yet available, which will minimize contamination between groups. The data will be collected with questionnaires delivered in person to the participants before the intervention (T0 time) and then four months later (T1 time) during their team or research meeting. Participants will be recruited in eight of the 12 Quebec FMU affiliated with Laval University, who will be randomly assigned to two equal groups: control and experimental. The intervention will consist in sending the SPIRO© mobile application to participants in the experimental group who will use it for a period of four months.
Read the detailed description
Hypothesis : The investigators hypothesize that the use of the SPIRO© application will increase the skills and confidence of family physicians and family medicine residents in prescribing and interpreting spirometry compared to the control group.
The project will be conducted in the following six major steps: 1) Collection of socio-demographic and behavioral characteristics of participants using sections A, B, C and D of the NAPI questionnaire in the control group; 2) Intervention in the control group (they will continue their daily medical practice without being subject to any intervention by our research team), for a period of 4 months; 3) Measurement of behavioral changes in the control group using Sections B, C, D and E of the NAPI questionnaire 4 months after the start of the study; 4) Collection of socio-demographic and behavioral data from participants in the experimental group using sections A, B, C and D of the NAPI questionnaire; 5) E-mail distribution of the application and use of the application by participants in the experimental group for a period of four months, 6) Measurement of behavioral changes in the experimental group after the use of the application, Using sections B, C, D and E of the NAPI questionnaire as well as a questionnaire on the application SPIRO© (SPIRO questionnaire) which will evaluate the usability of this one.
The study has been approved by the research ethic board of the Health and Social Services Center of the old capital - attached to the Integrated Center for Health and Social Services of the National Capital.
- Conditions
- COPD, Spirometry, Mobile Application
- Being tested
- SPIRO
- Keywords
- COPD, Spirometry, Mobile application
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIRODevice
Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Primary care physicians and residents in family medicine of family medicine units affiliated with Laval University. | |
| Experimental Group | Primary care physicians and residents in family medicine of family medicine units affiliated with Laval University that will use the mobile application SPIRO(c) for a period of four months. Receives: Device: SPIRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beliefs about capabilities - interpretation
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
Measured: six weeks
Secondary outcomes (14)
Beliefs about consequences - prescription
The beliefs about the consequences of primary care physicians and residents in family medicine regarding prescription of spirometry.
Measured: six weeks
Beliefs about consequences - interpretation
The beliefs about the consequences of primary care physicians and residents in family medicine regarding interpretation of spirometry.
Measured: six weeks
Beliefs about consequences - use of a mobile application
The beliefs about the consequences of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
Measured: six weeks
Moral norms - prescription
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding prescription of spirometry.
Measured: six weeks
Moral norms - interpretation
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding interpretation of spirometry.
Measured: six weeks
Moral norms - use of a mobile application
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
Measured: six weeks
Intentions - prescription
The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.
Measured: six weeks
Intentions - interpretation
The beliefs about the intentions of primary care physicians and residents in family medicine regarding interpretation of spirometry.
Measured: six weeks
Intentions - use of a mobile application
The beliefs about the intentions of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
Measured: six weeks
Social influence - prescription
The beliefs about the social influence of primary care physicians and residents in family medicine regarding prescription of spirometry.
Measured: six weeks
Social influence - interpretation
The beliefs about the social influence of primary care physicians and residents in family medicine regarding interpretation of spirometry.
Measured: six weeks
Social influence - use of a mobile application
The beliefs about the social influence of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
Measured: six weeks
Belief about capabilities - prescription
The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding prescription of spirometry.
Measured: six weeks
Belief about capabilities - use of a mobile application
The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Oct 2016
- Primary completion7 Jul 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-Philippe Boulet, Laval University
- Investigators
- Louis-Philippe Boulet, MD, Principal investigator, Heart and Lung Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206606
- Sponsor's protocol ID
- SPIRO-MD Residents
- Status last verified
- Oct 2020
- First submitted
- 26 Jun 2017
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Application to Facilitate the Interpretation of the Spirometry Test by Family Physicians and Family Medicine Residents: Impact on Prescription and Interpretation of This Test
- ClinicalTrials.gov ID
- NCT03206606
- Acronym / sponsor ID
- SPIRO-MD Residents
- Conditions
- COPD, Spirometry, Mobile Application
- Keywords
- COPD, Spirometry, Mobile application
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 7 Jul 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 2 Jul 2017 (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.
Problematic: Spirometry is used to objectify the obstructive syndrome defining chronic obstructive pulmonary disease (COPD). However, this test remains underused in the primary care. The tools available for its interpretation are little used and the existence of several decision algorithms can create confusion during the diagnosis.
Principal objective: To evaluate the impact of a mobile application (SPIRO©) on medical practice (interpretation and prescription of spirometry) of family physicians and family medicine residents working in family medicine units (FMU) in Quebec affiliated with Laval University.
Secondary objective : To evaluate the usability of SPIRO© among family physicians and residents in family medicine working in FMU in Quebec affiliated with Laval University.
Methods: This is a pre-post clinical trial with control group. Participants (family MD and family medicine residents) will be recruited from the various FMU affiliated with Laval University. Participants working in the FMU in the experimental group will be able to use the SPIRO® mobile application to facilitate interpretation of the spirometry test results while participants in the control group will not have access to it during the study. The basic characteristics of the participants and various behavioral parameters based on the theory of planned behavior concerning the interpretation and prescription of spirometry test will be measured. Data from the control group will be collected before those in the experimental group at the time the application is not yet available, which will minimize contamination between groups. The data will be collected with questionnaires delivered in person to the participants before the intervention (T0 time) and then four months later (T1 time) during their team or research meeting. Participants will be recruited in eight of the 12 Quebec FMU affiliated with Laval University, who will be randomly assigned to two equal groups: control and experimental. The intervention will consist in sending the SPIRO© mobile application to participants in the experimental group who will use it for a period of four months.
Detailed description
Hypothesis : The investigators hypothesize that the use of the SPIRO© application will increase the skills and confidence of family physicians and family medicine residents in prescribing and interpreting spirometry compared to the control group.
The project will be conducted in the following six major steps: 1) Collection of socio-demographic and behavioral characteristics of participants using sections A, B, C and D of the NAPI questionnaire in the control group; 2) Intervention in the control group (they will continue their daily medical practice without being subject to any intervention by our research team), for a period of 4 months; 3) Measurement of behavioral changes in the control group using Sections B, C, D and E of the NAPI questionnaire 4 months after the start of the study; 4) Collection of socio-demographic and behavioral data from participants in the experimental group using sections A, B, C and D of the NAPI questionnaire; 5) E-mail distribution of the application and use of the application by participants in the experimental group for a period of four months, 6) Measurement of behavioral changes in the experimental group after the use of the application, Using sections B, C, D and E of the NAPI questionnaire as well as a questionnaire on the application SPIRO© (SPIRO questionnaire) which will evaluate the usability of this one.
The study has been approved by the research ethic board of the Health and Social Services Center of the old capital - attached to the Integrated Center for Health and Social Services of the National Capital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Primary care physicians and residents in family medicine of family medicine units affiliated with Laval University. |
| Experimental Group | – | Device: SPIROPrimary care physicians and residents in family medicine of family medicine units affiliated with Laval University that will use the mobile application SPIRO(c) for a period of four months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care physicians and residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.
Key inclusion criteria (1 listed)
- Participants need to be primary care physicians or residents in family medicine of 18 years old or more working in one of the 12 family medicine units in Quebec affiliated with Laval University.
Key exclusion criteria (1 listed)
- Health professionals not practicing family medicine and residents of other specialties will not be eligible. Individuals who participated in the development of the " subjective Norms, Attitudes, Perceived behavioral control, Intentions (NAPI) " questionnaires (apparent validation) will be excluded.
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 |
|---|---|---|
| SPIROParticipants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months. | Device | Experimental Group |
Primary outcome
Beliefs about capabilities - interpretation
Time frame: six weeks
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
14 secondary outcomes
Beliefs about consequences - prescription
Time frame: six weeks
Beliefs about consequences - interpretation
Time frame: six weeks
Beliefs about consequences - use of a mobile application
Time frame: six weeks
Moral norms - prescription
Time frame: six weeks
Moral norms - interpretation
Time frame: six weeks
Moral norms - use of a mobile application
Time frame: six weeks
Intentions - prescription
Time frame: six weeks
Intentions - interpretation
Time frame: six weeks
Intentions - use of a mobile application
Time frame: six weeks
Social influence - prescription
Time frame: six weeks
Social influence - interpretation
Time frame: six weeks
Social influence - use of a mobile application
Time frame: six weeks
Belief about capabilities - prescription
Time frame: six weeks
Belief about capabilities - use of a mobile application
Time frame: six weeks
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 12 Oct 2020.
- 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.
Louis-Philippe Boulet, MD principal investigator
Heart and Lung Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Spirometry, run by Laval University at 8 sites in Canada.
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 1 inclusion and 1 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 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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?
Beliefs about capabilities - interpretation (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2020.