The Opal - COVID-19 Study
- Conditions
- COVID-19
- Interventions
- Other: sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID
- Registration Number
- NCT04978233
- Lead Sponsor
- Dr. Bertrand Lebouche
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MUHC COVID-19 patients sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID COVID-19 infected patients, newly diagnosed at the RI-MUHC
- Primary Outcome Measures
Name Time Method Change in the usability of the Opal app for COVID-19 from day 1 to day 14 the Health Information Technology Usability Evaluation Scale
Change in the acceptability of the Opal app for COVID-19 from day 1 to day 14 the Acceptability of Intervention Measure
- Secondary Outcome Measures
Name Time Method Change in symptoms from day 1 to day 14 Self-reported symptoms of COVID-19, collected daily
Change in vital signs blood pressure from day 1 to day 14 Systiolic/diastiolic mmHg, 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 respiration rate from day 1 to day 14 breaths per minute, collected daily
Change in vital signs oxygen saturation from day 1 to day 14 SpO2 %, collected daily
Change in vital signs heart rate from day 1 to day 14 beats per minute, collected daily
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
Trial Locations
- Locations (1)
Research Institute of the McGill University Health Centre
🇨🇦Montréal, Quebec, Canada