NCT03206606

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

October 12, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

June 26, 2017

Last Update Submit

October 8, 2020

Conditions

Keywords

COPDSpirometryMobile application

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Beliefs about consequences - prescription

    six weeks

  • Beliefs about consequences - interpretation

    six weeks

  • Beliefs about consequences - use of a mobile application

    six weeks

  • Moral norms - prescription

    six weeks

  • Moral norms - interpretation

    six weeks

  • +9 more secondary outcomes

Study Arms (2)

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.

Device: SPIRO

Interventions

SPIRODEVICE

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

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UMF de Manicouagan

Baie-Comeau, Quebec, G4Z 3B8, Canada

Location

UMF de Gaspé

Gaspé, Quebec, G4X 2W2, Canada

Location

UMF des Etchemins

Lac-Etchemin, Quebec, G0R 1S0, Canada

Location

UMF de Lévis

Lévis, Quebec, G6W 0J4, Canada

Location

Unité de médecine familiale - GMF Maizerets

Québec, Quebec, G1J 2G1, Canada

Location

UMF Saint-François d'Assise

Québec, Quebec, G1L 3L5, Canada

Location

Unité de médecine familiale Laval

Québec, Quebec, G1V 0B7, Canada

Location

UMF de Trois-Pistoles

Trois Pistoles, Quebec, G0L 4K0, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Louis-Philippe Boulet, MD

    Heart and Lung Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pneumologist

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

October 1, 2016

Primary Completion

July 7, 2017

Study Completion

December 20, 2017

Last Updated

October 12, 2020

Record last verified: 2020-10

Locations