- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03206606
Evaluation of a Mobile Application to Facilitate the Interpretation of Spirometry by Family Physicians and Residents
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Quebec
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Baie-Comeau, Quebec, Kanada, G4Z 3B8
- UMF de Manicouagan
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Gaspé, Quebec, Kanada, G4X 2W2
- UMF de Gaspé
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Lac-Etchemin, Quebec, Kanada, G0R 1S0
- UMF des Etchemins
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Lévis, Quebec, Kanada, G6W 0J4
- UMF de Lévis
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Quebec City, Quebec, Kanada, G1J 2G1
- Unité de médecine familiale - GMF Maizerets
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Quebec City, Quebec, Kanada, G1L 3L5
- UMF Saint-François d'Assise
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Quebec City, Quebec, Kanada, G1V 0B7
- Unité de médecine familiale Laval
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Trois-Pistoles, Quebec, Kanada, G0L 4K0
- UMF de Trois-Pistoles
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
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.
|
Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Beliefs about capabilities - interpretation
Časové okno: six weeks
|
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
|
six weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Beliefs about consequences - prescription
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: six weeks
|
The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.
|
six weeks
|
Intentions - interpretation
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Louis-Philippe Boulet, MD, Heart and Lung Institute
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- SPIRO-MD Residents
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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