- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Quebec
-
Baie-Comeau, Quebec, Canadá, G4Z 3B8
- UMF de Manicouagan
-
Gaspé, Quebec, Canadá, G4X 2W2
- UMF de Gaspé
-
Lac-Etchemin, Quebec, Canadá, G0R 1S0
- UMF des Etchemins
-
Lévis, Quebec, Canadá, G6W 0J4
- UMF de Lévis
-
Quebec City, Quebec, Canadá, G1J 2G1
- Unité de médecine familiale - GMF Maizerets
-
Quebec City, Quebec, Canadá, G1L 3L5
- UMF Saint-François d'Assise
-
Quebec City, Quebec, Canadá, G1V 0B7
- Unité de médecine familiale Laval
-
Trois-Pistoles, Quebec, Canadá, G0L 4K0
- UMF de Trois-Pistoles
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Beliefs about capabilities - interpretation
Prazo: six weeks
|
The beliefs about the capabilities of primary care physicians and residents in family medicine regarding interpretation of spirometry.
|
six weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Beliefs about consequences - prescription
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: six weeks
|
The beliefs about the intentions of primary care physicians and residents in family medicine regarding prescription of spirometry.
|
six weeks
|
Intentions - interpretation
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Louis-Philippe Boulet, MD, Heart and Lung Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- SPIRO-MD Residents
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em DPOC
-
Fraunhofer-Institute of Toxicology and Experimental...Institute for Pharmacology and Toxicology, RWTH AachenConcluídoVoluntários Saudáveis | COPD GOLD I a IV | Asma GINA 1 a 4Alemanha