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

8 octobre 2020 mis à jour par: Louis-Philippe Boulet, Laval University

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.

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

104

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Quebec
      • Baie-Comeau, Quebec, Canada, G4Z 3B8
        • UMF de Manicouagan
      • Gaspé, Quebec, Canada, G4X 2W2
        • UMF de Gaspé
      • Lac-Etchemin, Quebec, Canada, G0R 1S0
        • UMF des Etchemins
      • Lévis, Quebec, Canada, G6W 0J4
        • UMF de Lévis
      • Quebec City, Quebec, Canada, G1J 2G1
        • Unité de médecine familiale - GMF Maizerets
      • Quebec City, Quebec, Canada, G1L 3L5
        • UMF Saint-François d'Assise
      • Quebec City, Quebec, Canada, G1V 0B7
        • Unité de médecine familiale Laval
      • Trois-Pistoles, Quebec, Canada, G0L 4K0
        • UMF de Trois-Pistoles

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Dispositif: SPIRO
Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Beliefs about capabilities - interpretation
Délai: six weeks
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Beliefs about consequences - prescription
Délai: six weeks
The beliefs about the consequences of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Beliefs about consequences - interpretation
Délai: six weeks
The beliefs about the consequences of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Beliefs about consequences - use of a mobile application
Délai: 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.
six weeks
Moral norms - prescription
Délai: six weeks
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Moral norms - interpretation
Délai: six weeks
The beliefs about the moral norms of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Moral norms - use of a mobile application
Délai: 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.
six weeks
Intentions - prescription
Délai: six weeks
The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Intentions - interpretation
Délai: six weeks
The beliefs about the intentions of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Intentions - use of a mobile application
Délai: 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.
six weeks
Social influence - prescription
Délai: six weeks
The beliefs about the social influence of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Social influence - interpretation
Délai: six weeks
The beliefs about the social influence of primary care physicians and residents in family medicine regarding interpretation of spirometry.
six weeks
Social influence - use of a mobile application
Délai: 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.
six weeks
Belief about capabilities - prescription
Délai: six weeks
The beliefs about the belief about capabilities of primary care physicians and residents in family medicine regarding prescription of spirometry.
six weeks
Belief about capabilities - use of a mobile application
Délai: 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.
six weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Laval University

Les enquêteurs

  • Chercheur principal: Louis-Philippe Boulet, MD, Heart and Lung Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2016

Achèvement primaire (Réel)

7 juillet 2017

Achèvement de l'étude (Réel)

20 décembre 2017

Dates d'inscription aux études

Première soumission

26 juin 2017

Première soumission répondant aux critères de contrôle qualité

29 juin 2017

Première publication (Réel)

2 juillet 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 octobre 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 octobre 2020

Dernière vérification

1 octobre 2020

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • SPIRO-MD Residents

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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