The Opal - COVID-19 Study

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978233
• Other study ID #: 2021-6763
• Status: Completed
• Start date: December 8, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• sociodemographic 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.

Locations

Country	Name	City	State
Canada	Research Institute of the McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Bertrand Lebouche

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

Houlding E, Mate KKV, Engler K, Ortiz-Paredes D, Pomey MP, Cox J, Hijal T, Lebouché 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. Review. — View 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. Review. — View 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. — View Citation

Outcome

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