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Completed

NCT Number: NCT04978233

The Opal - COVID-19 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3T2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: from day 1 to day 14

    the Acceptability of Intervention Measure

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

    Time frame: from day 1 to day 14

    the Health Information Technology Usability Evaluation Scale

Secondary outcomes

  1. Contact with the healthcare team

    Time frame: from day 1 to day 14

    Rate of participant contact with the healthcare team

  2. Change in symptoms

    Time frame: from day 1 to day 14

    Self-reported symptoms of COVID-19, collected daily

  3. Patient satisfaction with scheduled teleconsultations

    Time frame: from day 1 to day 14

    the Short Questionnaire for Out-of-Hours Care

  4. Change in vital signs temperature

    Time frame: from day 1 to day 14

    Celcius degrees, collected daily

  5. Change in vital signs respiration rate

    Time frame: from day 1 to day 14

    breaths per minute, collected daily

  6. Change in vital signs oxygen saturation

    Time frame: from day 1 to day 14

    SpO2 %, collected daily

  7. Change in vital signs heart rate

    Time frame: from day 1 to day 14

    beats per minute, collected daily

  8. Change in vital signs blood pressure

    Time frame: from day 1 to day 14

    Systiolic/diastiolic mmHg, collected daily

Sponsors and collaborators

Lead sponsor

Dr. Bertrand Lebouche

Other

Registry information

Official study title

Use of the Opal Patient Portal Application for Daily Follow-up of People at Home With COVID-19: The Opal-COVID Feasibility Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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