The Opal - COVID-19 Study
22 de julio de 2021 actualizado por: Dr. Bertrand Lebouche
Use of the Opal Patient Portal Application for Daily Follow-up of People at Home With COVID-19: The Opal-COVID Feasibility Study
In collaboration with involved healthcare professionals and a patient advisory committee, this study tests the feasibility of using the Opal smartphone app to daily capture self-reported physical and psychological symptoms and vital signs among 50 people who are self-isolating at home with COVID-19.
A healthcare team at Montreal's MUHC will remotely monitor their condition and offer advice and teleconsultations, as needed.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In the context of the current pandemic, guidelines were issued by public health authorities to follow the progression of COVID-19 in the community, identify and treat affected people, and limit transmissions.
About 90% of people with COVID-19 only exhibit mild symptoms and recover.
However, a small percentage of people experience serious symptoms and require hospitalization for severe shortness of breath or low oxygen levels.
The current public health protocol is to identify people with COVID-19 and isolate them from others at home to prevent the virus from spreading.
Currently, there is no consensus on how to effectively follow-up and treat individuals with COVID-19 who are self-isolating at home.
Research is urgently needed.
This pilot study will assess the feasibility of one strategy for home-based COVID-19 follow-up .
The Opal app for COVID is a mobile application that will allow the completion of a daily symptom and vital sign follow-up questionnaire that will be monitored by a healthcare team.
Educational material will also be provided through the app.
The study will especially assess the acceptability and usability of the smartphone app.
Tipo de estudio
De observación
Inscripción (Actual)
50
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Quebec
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Montréal, Quebec, Canadá, H4A3T2
- Research Institute of the McGill University Health Centre
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
COVID-19 infected patients, newly diagnosed at the RI-MUHC
Descripción
Inclusion Criteria:
- 18 years or older
- Fluent in English and/or French
- Confirmed positive for PCR+ SARS-CoV-2
- Willing and able to understand the requirements of study participation and provide oral informed consent
- Access to a smartphone, tablet or computer at home
- Access to an internet connection at home or data plan on their smartphone
- Comfortable with the idea of using a new smartphone application to complete daily questionnaires, access educational material, and communicate with the healthcare team, or having someone to assist them with technology
- Prescribed self-isolation at home
- Proof of identity (passport, RAMQ, driver's license)
Exclusion Criteria:
- Have received a negative laboratory test result for the infection with COVID-19
- Confirmed negative for PCR+ SARS-CoV-2 and hospitalized
- Has any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a smartphone application
- Enrollment in any study involving an investigational drug for COVID-19 disease during the study period
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
MUHC COVID-19 patients
COVID-19 infected patients, newly diagnosed at the RI-MUHC
|
The intervention consists of having confirmed COVID-19 infected participants register for the Opal app and complete a daily questionnaire on symptoms related to their physical and mental health as well as on certain key vital signs (e.g., oxygen saturation, heart rate, temperature).
A nurse will check the questionnaire results each day and determine the need for a teleconsultation with an infectious disease physician.
Participants will be followed up for a minimum of 14 days, depending on their symptoms.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in the acceptability of the Opal app for COVID-19
Periodo de tiempo: from day 1 to day 14
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the Acceptability of Intervention Measure
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from day 1 to day 14
|
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Change in the usability of the Opal app for COVID-19
Periodo de tiempo: from day 1 to day 14
|
the Health Information Technology Usability Evaluation Scale
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from day 1 to day 14
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Contact with the healthcare team
Periodo de tiempo: from day 1 to day 14
|
Rate of participant contact with the healthcare team
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from day 1 to day 14
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Change in symptoms
Periodo de tiempo: from day 1 to day 14
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Self-reported symptoms of COVID-19, collected daily
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from day 1 to day 14
|
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Patient satisfaction with scheduled teleconsultations
Periodo de tiempo: from day 1 to day 14
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the Short Questionnaire for Out-of-Hours Care
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from day 1 to day 14
|
|
Change in vital signs temperature
Periodo de tiempo: from day 1 to day 14
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Celcius degrees, collected daily
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from day 1 to day 14
|
|
Change in vital signs respiration rate
Periodo de tiempo: from day 1 to day 14
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breaths per minute, collected daily
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from day 1 to day 14
|
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Change in vital signs oxygen saturation
Periodo de tiempo: from day 1 to day 14
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SpO2 %, collected daily
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from day 1 to day 14
|
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Change in vital signs heart rate
Periodo de tiempo: from day 1 to day 14
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beats per minute, collected daily
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from day 1 to day 14
|
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Change in vital signs blood pressure
Periodo de tiempo: from day 1 to day 14
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Systiolic/diastiolic mmHg, collected daily
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from day 1 to day 14
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Bertrand Lebouché, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Drew DA, Nguyen LH, Steves CJ, Menni C, Freydin M, Varsavsky T, Sudre CH, Cardoso MJ, Ourselin S, Wolf J, Spector TD, Chan AT; COPE Consortium. Rapid implementation of mobile technology for real-time epidemiology of COVID-19. Science. 2020 Jun 19;368(6497):1362-1367. doi: 10.1126/science.abc0473. Epub 2020 May 5.
- Irizarry T, DeVito Dabbs A, Curran CR. Patient Portals and Patient Engagement: A State of the Science Review. J Med Internet Res. 2015 Jun 23;17(6):e148. doi: 10.2196/jmir.4255.
- Kildea J, Battista J, Cabral B, Hendren L, Herrera D, Hijal T, Joseph A. Design and Development of a Person-Centered Patient Portal Using Participatory Stakeholder Co-Design. J Med Internet Res. 2019 Feb 11;21(2):e11371. doi: 10.2196/11371.
- Houlding E, Mate KKV, Engler K, Ortiz-Paredes D, Pomey MP, Cox J, Hijal T, Lebouche B. Barriers to Use of Remote Monitoring Technologies Used to Support Patients With COVID-19: Rapid Review. JMIR Mhealth Uhealth. 2021 Apr 20;9(4):e24743. doi: 10.2196/24743.
- Lessard D, Engler K, Ma Y, Rodriguez Cruz A, Vicente S; Opal-COVID-19 Patient Expert Committee; Kronfli N, Barkati S, Brouillette MJ, Cox J, Kildea J, Hijal T, Pomey MP, Bartlett SJ, Asselah J, Lebouche B. Remote Follow-up of Self-isolating Patients With COVID-19 Using a Patient Portal: Protocol for a Mixed Methods Pilot Study (Opal-COVID Study). JMIR Res Protoc. 2022 Aug 18;11(8):e35760. doi: 10.2196/35760.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de diciembre de 2020
Finalización primaria (Actual)
31 de marzo de 2021
Finalización del estudio (Actual)
31 de marzo de 2021
Fechas de registro del estudio
Enviado por primera vez
3 de diciembre de 2020
Primero enviado que cumplió con los criterios de control de calidad
22 de julio de 2021
Publicado por primera vez (Actual)
27 de julio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de julio de 2021
Última verificación
1 de julio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021-6763
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .