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The Opal - COVID-19 Study

22. juli 2021 opdateret af: Dr. Bertrand Lebouche

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4A3T2
        • Research Institute of the McGill University Health Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
MUHC COVID-19 patients
COVID-19 infected patients, newly diagnosed at the RI-MUHC
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the acceptability of the Opal app for COVID-19
Tidsramme: from day 1 to day 14
the Acceptability of Intervention Measure
from day 1 to day 14
Change in the usability of the Opal app for COVID-19
Tidsramme: from day 1 to day 14
the Health Information Technology Usability Evaluation Scale
from day 1 to day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Contact with the healthcare team
Tidsramme: from day 1 to day 14
Rate of participant contact with the healthcare team
from day 1 to day 14
Change in symptoms
Tidsramme: from day 1 to day 14
Self-reported symptoms of COVID-19, collected daily
from day 1 to day 14
Patient satisfaction with scheduled teleconsultations
Tidsramme: from day 1 to day 14
the Short Questionnaire for Out-of-Hours Care
from day 1 to day 14
Change in vital signs temperature
Tidsramme: from day 1 to day 14
Celcius degrees, collected daily
from day 1 to day 14
Change in vital signs respiration rate
Tidsramme: from day 1 to day 14
breaths per minute, collected daily
from day 1 to day 14
Change in vital signs oxygen saturation
Tidsramme: from day 1 to day 14
SpO2 %, collected daily
from day 1 to day 14
Change in vital signs heart rate
Tidsramme: from day 1 to day 14
beats per minute, collected daily
from day 1 to day 14
Change in vital signs blood pressure
Tidsramme: from day 1 to day 14
Systiolic/diastiolic mmHg, collected daily
from day 1 to day 14

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dr. Bertrand Lebouche

Efterforskere

  • Ledende efterforsker: Bertrand Lebouché, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. december 2020

Primær færdiggørelse (Faktiske)

31. marts 2021

Studieafslutning (Faktiske)

31. marts 2021

Datoer for studieregistrering

Først indsendt

3. december 2020

Først indsendt, der opfyldte QC-kriterier

22. juli 2021

Først opslået (Faktiske)

27. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2021

Sidst verificeret

1. juli 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-6763

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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