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Trial registered on ANZCTR
Registration number
ACTRN12620000640909
Ethics application status
Approved
Date submitted
26/05/2020
Date registered
1/06/2020
Date last updated
16/07/2021
Date data sharing statement initially provided
1/06/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
A phase II, open label non-randomised clinical trial of the safety and efficacy of the CovidCare app to support self-monitoring for COVID-19 symptoms in self-isolation and to determine the impacts on mental health
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Scientific title
A phase II, open label non-randomised clinical trial of the safety and efficacy of the CovidCare app to support self-monitoring for COVID-19 symptoms in self-isolation and to determine the impacts on mental health
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Secondary ID [1]
301223
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Nil
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Universal Trial Number (UTN)
U1111-1251-7257
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Trial acronym
CovidCare
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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Mental Health
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Condition category
Condition code
Respiratory
315486
315486
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0
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Other respiratory disorders / diseases
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Mental Health
315487
315487
0
0
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Depression
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Mental Health
315488
315488
0
0
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Anxiety
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Cardiovascular
315702
315702
0
0
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Other cardiovascular diseases
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Infection
315734
315734
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
317525
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Treatment: Other
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Comparator / control treatment
No Control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Efficacy will be determined by an audit conducted by a data analyst of the daily vital sign entries to assess appropriateness of values and accuracy of triage outcomes. Statistical evaluations will be completed of threshold ranges to determine accuracy and safety of vital sign monitoring and triage.
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Assessment method [1]
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Timepoint [1]
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Data is entered daily from days 1-4 and 2 times per day for days 5-14 post COVID-19 diagnosis. Additional data may be requested to be entered by the CovidCare app if data is beyond pre-determined thresholds and requires verification.
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Primary outcome [2]
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Safety will be determined by evaluating the raw vital sign data entered into the app to ensure that the data has triggered the correct notifications to participants based on the pre-determined thresholds established to identify deterioration warranting further medical advice.
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Assessment method [2]
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Timepoint [2]
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Data will be analysed daily for 14 days
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Secondary outcome [1]
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User experiences of app and care pathways as detemined by analyzing the sub-set of qualitative interviews. Analysis of the interviews will be based around the four main domains of the uMARS which are: engagement, functionality, aesthetics and information quality.
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Assessment method [1]
382730
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Timepoint [1]
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Approximately 4 weeks post CovidCare app download
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Secondary outcome [2]
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Depression scores as determined by responses to PHQ-2.
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Assessment method [2]
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Timepoint [2]
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Baseline (day of app download), and Day 14 and Day 28 after baseline
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Secondary outcome [3]
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Post-trial (as determined by 2 weeks post last log in and use of app date) sub-study with qualitative interviews with users who have recovered to explore experiences, emotional and mental health needs.
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Assessment method [3]
383330
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Timepoint [3]
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Approximately 4 weeks post CovidCare app download
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Secondary outcome [4]
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Anxiety screening scores as determined by responses to the GAD-2
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Assessment method [4]
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Timepoint [4]
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Baseline (day of app download), and Day 14 and Day 28 after baseline
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation. Single group
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No allocation. Single group
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Code allocated to participating clinic providing COVID-19 diagnoses to restrict download from app store to only the attendees at the participating clinics
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Sample size
Estimates for the clinical trial sample size for a phase II open label, non-randomised trial to test safety and efficacy were calculated by using the lower end figures of current tests reported by active Australian respiratory clinics. These test rate estimates were gathered from a brief consultation conducted by phone with a sub-set of the currently operating 61/100 respiratory clinics across Australia. Currently data on tests conducted per individual respiratory clinics is not publicly available.
We estimated, based on reported figures from our consultation that, on average, all 61 clinics conducted approximately 150 tests per week. We based our sample size for determining the safety and efficacy of CovidCare for self-monitoring and screening for mental health on the Covid-19 positive test group only (1%). We based our attrition figures on previously reported m-health randomised controlled trials which show attritions ranges from 70-90%.
Using the conservative estimates as a guide with 80% attrition, 200 COVID-19 users will provide sufficient data to establish performance safety of app and to determine efficacy related to self-monitoring. These are estimates of averages that have been calculated as a guide to determine the clinical evaluation time frame and potential sample that will be available to determine safety and efficacy. There will be variability across clinics in terms of numbers of test per week conducted, and numbers will be lower in clinics that have just started compared to those with processes and procedures in place for longer.
If there are 100 respiratory clinics available during the trial life (which is the projected number of total respiratory clinics nationally), the potential total sample size would increase and result in a sample of 504 (70% attrition), 336 (80% attrition) and 168 (90% attrition).
Assessment of performance.
The performance endpoint of safety will be determined by using only the Covid-19 positive group of participants recruited to the trial for validation of the algorithm. This is the group who are the most likely to be a full 14 day use group due to self-isolation requirements, and who might experience deterioration as currently outlined in the negative trend assessments completed by the app.
Performance, safety and efficacy will be determined by evaluating the raw values entered for vital signs and assessing the algorithm thresholds. This includes an analysis of the data to ensure that negative trends of 10% and 20% are sufficiently safe. The full methods for validation will be outlined in the SAP.
Assessment of safety
The safety parameters for CovidCare will be investigated by evaluating the raw values entered by patients into the app for daily readings of vital signs only to determine these are within range of the status groups that the patient received information on. These evaluations will be conducted by the Data Manager for the trial.
Qualitative Substudy.
Responses will be transcribed and subjected to thematic analysis to identify broad themes on the experiences of people isolating with a COVID-19 diagnosis.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
8/06/2020
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Actual
14/08/2020
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
31/01/2022
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Actual
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Sample size
Target
200
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Accrual to date
27
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Melbourne
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Address [1]
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Grattan Street,
Parkville,
VIC 3010
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
Grattan Street,
Parkville,
VIC 3010
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
306082
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Address [1]
306082
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Country [1]
306082
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of Melbourne Human Ethics Sub Committee
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Ethics committee address [1]
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Office of Research Ethics & Integrity
Level 5, 161 Barry Street
The University of Melbourne
VIC 3010
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Ethics committee country [1]
305954
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Australia
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Date submitted for ethics approval [1]
305954
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14/04/2020
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Approval date [1]
305954
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22/05/2020
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Ethics approval number [1]
305954
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2056765
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Summary
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
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Trial website
https://medicine.unimelb.edu.au/research-groups/general-practice-research/mental-health-program/covid-care
https://www.covidcare.io/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Victoria Palmer
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Address
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Integrated Mental Health Research Program
Department of General Practice
Medicine Dentistry and Health Sciences
Level 2 780 Elizabeth Street
Parkville, Victoria, 3010
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Country
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Australia
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Phone
102194
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+61 03 8344 4987
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Maria Potiriadis
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Address
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Integrated Mental Health Research Program
Department of General Practice
Medicine Dentistry and Health Sciences
Level 2 780 Elizabeth Street
Parkville, Victoria, 3010
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Country
102195
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Australia
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Phone
102195
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+61 03 8344 9719
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Fax
102195
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Email
102195
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Victoria Palmer
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Address
102196
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Integrated Mental Health Research Program
Department of General Practice
Medicine Dentistry and Health Sciences
Level 2 780 Elizabeth Street
Parkville, Victoria, 3010
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Country
102196
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Australia
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Phone
102196
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+61 03 8344 4987
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Fax
102196
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Email
102196
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual de-identified participant data of published results and individual participant data of primary and secondary outcomes.
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When will data be available (start and end dates)?
Data will be available from 12 months after publication for a period of 15years while data has been retained
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Available to whom?
Researchers who provide a methodologically sound proposal, reviewed case by case and subject to ethical approval at the Primary Sponsor.
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Available for what types of analyses?
The analysis specified in the agreed proposal.
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How or where can data be obtained?
Emailing principal investigator:
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8081
Ethical approval
379784-(Uploaded-26-05-2020-10-23-19)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF