Clinical trial NCT04978233: The Opal - COVID-19 Study
Official title: Use of the Opal Patient Portal Application for Daily Follow-up of People at Home With COVID-19: The Opal-COVID Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
self-isolation
mHealth
patient portals
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 infected patients, newly diagnosed at the RI-MUHC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the acceptability of the Opal app for COVID-19
timeFrame: from day 1 to day 14
measure: Change in the usability of the Opal app for COVID-19
timeFrame: from day 1 to day 14
Secondary outcomes:
measure: Contact with the healthcare team
timeFrame: from day 1 to day 14
measure: Change in symptoms
timeFrame: from day 1 to day 14
measure: Patient satisfaction with scheduled teleconsultations
timeFrame: from day 1 to day 14
measure: Change in vital signs temperature
timeFrame: from day 1 to day 14
measure: Change in vital signs respiration rate
timeFrame: from day 1 to day 14
measure: Change in vital signs oxygen saturation
timeFrame: from day 1 to day 14
measure: Change in vital signs heart rate
timeFrame: from day 1 to day 14
measure: Change in vital signs blood pressure
timeFrame: from day 1 to day 14
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Bertrand Lebouché, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.