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Evaluation of a Mobile Application to Facilitate the Interpretation of Spirometry by Family Physicians and Residents

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ClinicalTrials.gov Identifier: NCT03206606
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Louis-Philippe Boulet, Laval University

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.


Condition or disease Intervention/treatment
COPD Spirometry Mobile Application Device: SPIRO

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.


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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : July 7, 2017
Estimated Study Completion Date : December 20, 2017

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Beliefs about consequences - prescription [ Time Frame: six weeks ]
    The beliefs about the consequences of primary care physicians and residents in family medicine regarding prescription of spirometry.

  2. Beliefs about consequences - interpretation [ Time Frame: six weeks ]
    The beliefs about the consequences of primary care physicians and residents in family medicine regarding interpretation of spirometry.

  3. Beliefs about consequences - use of a mobile application [ Time Frame: six weeks ]
    The beliefs about the consequences of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.

  4. Moral norms - prescription [ Time Frame: six weeks ]
    The beliefs about the moral norms of primary care physicians and residents in family medicine regarding prescription of spirometry.

  5. Moral norms - interpretation [ Time Frame: six weeks ]
    The beliefs about the moral norms of primary care physicians and residents in family medicine regarding interpretation of spirometry.

  6. Moral norms - use of a mobile application [ Time Frame: six weeks ]
    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.

  7. Intentions - prescription [ Time Frame: six weeks ]
    The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.

  8. Intentions - interpretation [ Time Frame: six weeks ]
    The beliefs about the intentions of primary care physicians and residents in family medicine regarding interpretation of spirometry.

  9. Intentions - use of a mobile application [ Time Frame: six weeks ]
    The beliefs about the intentions of primary care physicians and residents in family medicine regarding the use of a mobile application to interpret spirometry.

  10. Social influence - prescription [ Time Frame: six weeks ]
    The beliefs about the social influence of primary care physicians and residents in family medicine regarding prescription of spirometry.

  11. Social influence - interpretation [ Time Frame: six weeks ]
    The beliefs about the social influence of primary care physicians and residents in family medicine regarding interpretation of spirometry.

  12. Social influence - use of a mobile application [ Time Frame: six weeks ]
    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.

  13. Belief about capabilities - prescription [ Time Frame: six weeks ]
    The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding prescription of spirometry.

  14. Belief about capabilities - use of a mobile application [ Time Frame: six weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03206606


Locations
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Canada, Quebec
UMF de Manicouagan
Baie-Comeau, Quebec, Canada, G4Z 3B8
UMF de Gaspé
Gaspé, Quebec, Canada, G4X 2W2
UMF des Etchemins
Lac-Etchemin, Quebec, Canada, G0R 1S0
UMF de Lévis
Lévis, Quebec, Canada, G6W 0J4
Unité de médecine familiale - GMF Maizerets
Quebec City, Quebec, Canada, G1J 2G1
UMF Saint-François d'Assise
Quebec City, Quebec, Canada, G1L 3L5
Unité de médecine familiale Laval
Quebec City, Quebec, Canada, G1V 0B7
UMF de Trois-Pistoles
Trois-Pistoles, Quebec, Canada, G0L 4K0
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Louis-Philippe Boulet, MD Heart and Lung Institute

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Responsible Party: Louis-Philippe Boulet, Pneumologist, Laval University
ClinicalTrials.gov Identifier: NCT03206606     History of Changes
Other Study ID Numbers: SPIRO-MD Residents
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Louis-Philippe Boulet, Laval University:
COPD
Spirometry
Mobile application