The Opal - COVID-19 Study

NCT04978233 | Completed

• 1 other identifier: 2021-6763
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVID-19; self-isolation; mHealth; patient portals

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Contact with the healthcare team

  from day 1 to day 14

• Change in symptoms

  from day 1 to day 14

• Patient satisfaction with scheduled teleconsultations

  from day 1 to day 14

• Change in vital signs temperature

  from day 1 to day 14

• Change in vital signs respiration rate

  from day 1 to day 14

Study Arms (1)

MUHC COVID-19 patients

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

Interventions

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

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.

MUHC COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID-19 infected patients, newly diagnosed at the RI-MUHC

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Bertrand Lebouche: lead

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3T2, Canada

Location

Related Publications (5)

• 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.

  PMID: 26104044 BACKGROUND

• 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.

  PMID: 32371477 BACKGROUND

• 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.

  PMID: 30741643 BACKGROUND

• Houlding E, Mate KKV, Engler K, Ortiz-Paredes D, Pomey MP, Cox J, Hijal T, Lebouche 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.

  PMID: 33769943 BACKGROUND

• Lessard D, Engler K, Ma Y, Rodriguez Cruz A, Vicente S; Opal-COVID-19 Patient Expert Committee; Kronfli N, Barkati S, Brouillette MJ, Cox J, Kildea J, Hijal T, Pomey MP, Bartlett SJ, Asselah J, Lebouche B. Remote Follow-up of Self-isolating Patients With COVID-19 Using a Patient Portal: Protocol for a Mixed Methods Pilot Study (Opal-COVID Study). JMIR Res Protoc. 2022 Aug 18;11(8):e35760. doi: 10.2196/35760.

  PMID: 35820054 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Health

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Bertrand Lebouché, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bertrand Lebouché MD, PhD

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: July 27, 2021
• Study Start: December 8, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)