The Opal - COVID-19 Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of the Opal Patient Portal Application for Daily Follow-up of People at Home With COVID-19: The Opal-COVID Feasibility Study

Conditions
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COVID-19

Intervention / Treatment
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* Other: sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MUHC COVID-19 patients<br>COVID-19 infected patients, newly diagnosed at the RI-MUHC | Other: sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the acceptability of the Opal app for COVID-19 | the Acceptability of Intervention Measure | from day 1 to day 14 | 
| Change in the usability of the Opal app for COVID-19 | the Health Information Technology Usability Evaluation Scale | from day 1 to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact with the healthcare team | Rate of participant contact with the healthcare team | from day 1 to day 14 | 
| Change in symptoms | Self-reported symptoms of COVID-19, collected daily | from day 1 to day 14 | 
| Patient satisfaction with scheduled teleconsultations | the Short Questionnaire for Out-of-Hours Care | from day 1 to day 14 | 
| Change in vital signs temperature | Celcius degrees, collected daily | from day 1 to day 14 | 
| Change in vital signs respiration rate | breaths per minute, collected daily | from day 1 to day 14 | 
| Change in vital signs oxygen saturation | SpO2 %, collected daily | from day 1 to day 14 | 
| Change in vital signs heart rate | beats per minute, collected daily | from day 1 to day 14 | 
| Change in vital signs blood pressure | Systiolic/diastiolic mmHg, collected daily | from day 1 to day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, self-isolation, mHealth, patient portals