COVID-19
Conditions
Keywords
COVID-19, self-isolation, mHealth, patient portals
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.
Interventions
OTHERsociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID
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.
Sponsors
Dr. Bertrand Lebouche
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the acceptability of the Opal app for COVID-19 | from day 1 to day 14 | the Acceptability of Intervention Measure |
| Change in the usability of the Opal app for COVID-19 | from day 1 to day 14 | the Health Information Technology Usability Evaluation Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with scheduled teleconsultations | from day 1 to day 14 | the Short Questionnaire for Out-of-Hours Care |
| Change in vital signs temperature | from day 1 to day 14 | Celcius degrees, collected daily |
| Change in vital signs respiration rate | from day 1 to day 14 | breaths per minute, collected daily |
| Contact with the healthcare team | from day 1 to day 14 | Rate of participant contact with the healthcare team |
| Change in vital signs heart rate | from day 1 to day 14 | beats per minute, collected daily |
| Change in vital signs blood pressure | from day 1 to day 14 | Systiolic/diastiolic mmHg, collected daily |
| Change in vital signs oxygen saturation | from day 1 to day 14 | SpO2 %, collected daily |
| Change in symptoms | from day 1 to day 14 | Self-reported symptoms of COVID-19, collected daily |
Countries
Canada
Outcome results
None listed