Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-30 @ 4:10 PM
Study NCT ID:
NCT04978233
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2020-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Opal - COVID-19 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-22', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the acceptability of the Opal app for COVID-19', 'timeFrame': 'from day 1 to day 14', 'description': 'the Acceptability of Intervention Measure'}, {'measure': 'Change in the usability of the Opal app for COVID-19', 'timeFrame': 'from day 1 to day 14', 'description': 'the Health Information Technology Usability Evaluation Scale'}], 'secondaryOutcomes': [{'measure': 'Contact with the healthcare team', 'timeFrame': 'from day 1 to day 14', 'description': 'Rate of participant contact with the healthcare team'}, {'measure': 'Change in symptoms', 'timeFrame': 'from day 1 to day 14', 'description': 'Self-reported symptoms of COVID-19, collected daily'}, {'measure': 'Patient satisfaction with scheduled teleconsultations', 'timeFrame': 'from day 1 to day 14', 'description': 'the Short Questionnaire for Out-of-Hours Care'}, {'measure': 'Change in vital signs temperature', 'timeFrame': 'from day 1 to day 14', 'description': 'Celcius degrees, collected daily'}, {'measure': 'Change in vital signs respiration rate', 'timeFrame': 'from day 1 to day 14', 'description': 'breaths per minute, collected daily'}, {'measure': 'Change in vital signs oxygen saturation', 'timeFrame': 'from day 1 to day 14', 'description': 'SpO2 %, collected daily'}, {'measure': 'Change in vital signs heart rate', 'timeFrame': 'from day 1 to day 14', 'description': 'beats per minute, collected daily'}, {'measure': 'Change in vital signs blood pressure', 'timeFrame': 'from day 1 to day 14', 'description': 'Systiolic/diastiolic mmHg, collected daily'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'self-isolation', 'mHealth', 'patient portals'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '26104044', 'type': 'BACKGROUND', '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.'}, {'pmid': '32371477', 'type': 'BACKGROUND', 'citation': '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': '30741643', 'type': 'BACKGROUND', '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.'}, {'pmid': '33769943', 'type': 'BACKGROUND', 'citation': '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': '35820054', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 infected patients, newly diagnosed at the RI-MUHC', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* Fluent in English and/or French\n* Confirmed positive for PCR+ SARS-CoV-2\n* Willing and able to understand the requirements of study participation and provide oral informed consent\n* Access to a smartphone, tablet or computer at home\n* Access to an internet connection at home or data plan on their smartphone\n* 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\n* Prescribed self-isolation at home\n* Proof of identity (passport, RAMQ, driver's license)\n\nExclusion Criteria:\n\n* Have received a negative laboratory test result for the infection with COVID-19\n* Confirmed negative for PCR+ SARS-CoV-2 and hospitalized\n* 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\n* Enrollment in any study involving an investigational drug for COVID-19 disease during the study period"}, 'identificationModule': {'nctId': 'NCT04978233', 'briefTitle': 'The Opal - COVID-19 Study', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Use of the Opal Patient Portal Application for Daily Follow-up of People at Home With COVID-19: The Opal-COVID Feasibility Study', 'orgStudyIdInfo': {'id': '2021-6763'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MUHC COVID-19 patients', 'description': 'COVID-19 infected patients, newly diagnosed at the RI-MUHC', 'interventionNames': ['Other: sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID']}], 'interventions': [{'name': 'sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['MUHC COVID-19 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4A3T2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Research Institute of the McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Bertrand Lebouché, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Bertrand Lebouche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Bertrand Lebouché MD, PhD', 'investigatorFullName': 'Dr. Bertrand Lebouche', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}