None listed
Conditions
Brief summary
CovidCare provides patients with symptoms and/or a diagnosis of COVID-19 with self-monitoring support during self-isolation. CovidCare is also providing researchers with critical information about emotional needs and the impact on mental health of self-isolation due to Covid-19. The aim of the study is to make sure that CovidCare is safe to use and that it performs accurately. From this study we also hope to better understand the mental health impacts and well-being of people who have received a positive diagnosis for COVID-19
Interventions
This is a Phase II safety and efficacy study of CovidCare as a software as medical device product.
CovidCare is a mobile phone based application designed to assist people to self-monitor their symptoms of COVID-19 during self-isolation and to determine the mental health impacts of COVID-19 and self-isolation.
Upon attendance at the University of Melbourne health service, primary care clinic or dedicated respiratory clinics responsible for administering testing for COVID-19, people can download
This is a Phase II safety and efficacy study of CovidCare as a software as medical device product. CovidCare is a mobile phone based application designed to assist people to self-monitor their symptoms of COVID-19 during self-isolation and to determine the mental health impacts of COVID-19 and self-isolation. Upon attendance at the University of Melbourne health service, primary care clinic or dedicated respiratory clinics responsible for administering testing for COVID-19, people can download the app and use the features to self-monitor key respiratory and cardiac vital signs for COVID-19. The app provides guides people about symptoms and when to seek medical assistance and is designed to support people self isolating, and to self-manage COVID-19 at home. The app also includes screening measures for depression and anxiety to determine the mental health impacts and makes suggestions if people should seek further professional support for their mental health. People will use the CovidCare app until their symptoms resolve or a diagnosis is returned. For people who receive a negative COVID-19 diagnosis, they can continue to use the app while they are in isolation but they may discontinue using the app. For people who receive positive COVID-19 diagnosis, they will be encouraged to continue using the app for 14 days, or until symptoms resolve. Physical Data is collected daily for days 1 to 4, and twice per day for days 5 to 14 based on current guidelines that indicate that symptoms for COVID-19 can deteriorate from day 5 onward. This data includes: - Heart Rate - Respiration Rate - Temperature - Breath out - SpO2 Oxygen Saturation (where an oximeter is available and 0 if unavailable) If the information entered by the user into CovidCare for physical data is outside a defined normal clinical range a user will be prompted to re-complete their assessment in 2 hours. If user symptoms have deteriorated beyond a pre-determined threshold (calculated over a 72 and 96 hour window - e.g. 3 days allowing for a day of missing data if someone skipped measurements of day 2 or 3), the user will be prompted either to monitor and consider seeking medical advice or to urgently seek medical advice. Where there is evidence of data being outside of healthy ranges, and signifying deterioration, the app will prompt the user to contact their general practitioner, call 000 for emergency care, or attend an emergency department. Mental Health Data is collected at onboarding/baseline, week 2 post baseline and week 4 post baseline using: Personal Health Questionnaire (PHQ2) – Measure of Depression. Generalised Anxiety Disorder (GAD2) – Measure of Anxiety. Participants will be asked to complete two questions for depression screening and two questions for anxiety screening. Participants who score equal to or more than three on either questionnaire will be recommended to contact a GP to discuss their emotional needs. Scores equal to or more than 3 than typically indicate probable symptoms and the recommendation is for completion a full PHQ9 and GAD7 assessment.
Sponsors
University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years and above presenting at the University of Melbourne health service, primary care clinic or designated respiratory clinic for Covid-19 testing.
Exclusion criteria
1. Patients aged under 18 years 2. Patients with existing conditions: lung and respiratory related diseases, heart conditions, type 1 or 2 diabetes are excluded from app usage until they have undertaken a medical review with their general practitioner or usual medical care provider 3. Patient requiring Prednisolone > 10mg daily for more than 2 weeks 4. Patient requiring immunosuppression to manage chronic disease including vasculitis, autoimmune disease, transplantation or inflammatory condition 5. Patient with known malignancy who is or has received chemotherapy, immunotherapy, targeted antibody therapy or radiotherapy within 3 months from Covid 19 diagnosis 6. Patient with acquired or genetic immunodeficiency who require regular intravenous immunoglobulin therapy 7. Patient with asthma who has been prescribed targeted therapy including anti IgE therapy (omalizumab)or anti Il 5 therapy (mepolizumab, benralizumab).
Outcome results
None listed