AzTrials
AzTrials

COVID-19NCT04978233

The Opal - COVID-19 Study

An observational study of COVID-19, run by Dr. Bertrand Lebouche at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID
How many people
50 participants
Where
1 siteCanada
Study dates
8 Dec 2020to 31 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A3T2

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
COVID-19
Being tested
sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID
Keywords
COVID-19, self-isolation, mHealth, patient portals
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVIDOther

    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.

Study groups in NCT04978233
Study groupRoleWhat they receive
MUHC COVID-19 patientsCOVID-19 infected patients, newly diagnosed at the RI-MUHC
Receives: Other: sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the acceptability of the Opal app for COVID-19

    the Acceptability of Intervention Measure

    Measured: from day 1 to day 14

  2. Change in the usability of the Opal app for COVID-19

    the Health Information Technology Usability Evaluation Scale

    Measured: from day 1 to day 14

Secondary outcomes (8)

  1. Contact with the healthcare team

    Rate of participant contact with the healthcare team

    Measured: from day 1 to day 14

  2. Change in symptoms

    Self-reported symptoms of COVID-19, collected daily

    Measured: from day 1 to day 14

  3. Patient satisfaction with scheduled teleconsultations

    the Short Questionnaire for Out-of-Hours Care

    Measured: from day 1 to day 14

  4. Change in vital signs temperature

    Celcius degrees, collected daily

    Measured: from day 1 to day 14

  5. Change in vital signs respiration rate

    breaths per minute, collected daily

    Measured: from day 1 to day 14

  6. Change in vital signs oxygen saturation

    SpO2 %, collected daily

    Measured: from day 1 to day 14

  7. Change in vital signs heart rate

    beats per minute, collected daily

    Measured: from day 1 to day 14

  8. Change in vital signs blood pressure

    Systiolic/diastiolic mmHg, collected daily

    Measured: from day 1 to day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2021
  2. Study start8 Dec 2020
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978233
Sponsor's protocol ID
2021-6763
Status last verified
Jul 2021
First submitted
3 Dec 2020
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26104044

  • 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.

    PubMed 32371477

  • 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.

    PubMed 30741643

  • 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.

    PubMed 33769943

  • 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.

    PubMed 35820054

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Dr. Bertrand Lebouche at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the acceptability of the Opal app for COVID-19 (time frame: from day 1 to day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04978233, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021; AzTrials last refreshed its copy on 28 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in