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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206606
Other study ID # SPIRO-MD Residents
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2016
Est. completion date December 20, 2017

Study information

Verified date October 2020
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date December 20, 2017
Est. primary completion date July 7, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SPIRO
Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.

Locations

Country Name City State
Canada UMF de Manicouagan Baie-Comeau Quebec
Canada UMF de Gaspé Gaspé Quebec
Canada UMF des Etchemins Lac-Etchemin Quebec
Canada UMF de Lévis Lévis Quebec
Canada UMF Saint-François d'Assise Quebec City Quebec
Canada Unité de médecine familiale - GMF Maizerets Quebec City Quebec
Canada Unité de médecine familiale Laval Quebec City Quebec
Canada UMF de Trois-Pistoles Trois-Pistoles Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beliefs about capabilities - interpretation The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary Beliefs about consequences - prescription The beliefs about the consequences of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Beliefs about consequences - interpretation The beliefs about the consequences of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary 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. six weeks
Secondary Moral norms - prescription The beliefs about the moral norms of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Moral norms - interpretation The beliefs about the moral norms of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary 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. six weeks
Secondary Intentions - prescription The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Intentions - interpretation The beliefs about the intentions of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary 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. six weeks
Secondary Social influence - prescription The beliefs about the social influence of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary Social influence - interpretation The beliefs about the social influence of primary care physicians and residents in family medicine regarding interpretation of spirometry. six weeks
Secondary 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. six weeks
Secondary Belief about capabilities - prescription The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding prescription of spirometry. six weeks
Secondary 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. six weeks
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