The Opal - COVID-19 Study

Dr. Bertrand Lebouche50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19

Interventions

sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVIDOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada