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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
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
Secondary ID [1] 301223 0
Nil
Universal Trial Number (UTN)
U1111-1251-7257
Trial acronym
CovidCare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317381 0
Mental Health 317382 0
Condition category
Condition code
Respiratory 315486 315486 0 0
Other respiratory disorders / diseases
Mental Health 315487 315487 0 0
Depression
Mental Health 315488 315488 0 0
Anxiety
Cardiovascular 315702 315702 0 0
Other cardiovascular diseases
Infection 315734 315734 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317525 0
Treatment: Other
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323726 0
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.
Timepoint [1] 323726 0
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.
Primary outcome [2] 323944 0
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.
Timepoint [2] 323944 0
Data will be analysed daily for 14 days
Secondary outcome [1] 382730 0
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.
Timepoint [1] 382730 0
Approximately 4 weeks post CovidCare app download
Secondary outcome [2] 383329 0
Depression scores as determined by responses to PHQ-2.
Timepoint [2] 383329 0
Baseline (day of app download), and Day 14 and Day 28 after baseline
Secondary outcome [3] 383330 0
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.
Timepoint [3] 383330 0
Approximately 4 weeks post CovidCare app download
Secondary outcome [4] 383385 0
Anxiety screening scores as determined by responses to the GAD-2
Timepoint [4] 383385 0
Baseline (day of app download), and Day 14 and Day 28 after baseline

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).



Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation. Single group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No allocation. Single group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/06/2020
Actual
14/08/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
200
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305670 0
University
Name [1] 305670 0
University of Melbourne
Country [1] 305670 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Grattan Street,
Parkville,
VIC 3010
Country
Australia
Secondary sponsor category [1] 306082 0
None
Name [1] 306082 0
Address [1] 306082 0
Country [1] 306082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305954 0
University of Melbourne Human Ethics Sub Committee
Ethics committee address [1] 305954 0
Ethics committee country [1] 305954 0
Australia
Date submitted for ethics approval [1] 305954 0
14/04/2020
Approval date [1] 305954 0
22/05/2020
Ethics approval number [1] 305954 0
2056765

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102194 0
A/Prof Victoria Palmer
Address 102194 0
Integrated Mental Health Research Program
Department of General Practice
Medicine Dentistry and Health Sciences
Level 2 780 Elizabeth Street
Parkville, Victoria, 3010
Country 102194 0
Australia
Phone 102194 0
+61 03 8344 4987
Fax 102194 0
Email 102194 0
v.palmer@unimelb.edu.au
Contact person for public queries
Name 102195 0
Maria Potiriadis
Address 102195 0
Integrated Mental Health Research Program
Department of General Practice
Medicine Dentistry and Health Sciences
Level 2 780 Elizabeth Street
Parkville, Victoria, 3010
Country 102195 0
Australia
Phone 102195 0
+61 03 8344 9719
Fax 102195 0
Email 102195 0
covidcare-trial@unimelb.edu.au
Contact person for scientific queries
Name 102196 0
Victoria Palmer
Address 102196 0
Integrated Mental Health Research Program
Department of General Practice
Medicine Dentistry and Health Sciences
Level 2 780 Elizabeth Street
Parkville, Victoria, 3010
Country 102196 0
Australia
Phone 102196 0
+61 03 8344 4987
Fax 102196 0
Email 102196 0
covidcare-trial@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data of published results and individual participant data of primary and secondary outcomes.
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
Available to whom?
Researchers who provide a methodologically sound proposal, reviewed case by case and subject to ethical approval at the Primary Sponsor.
Available for what types of analyses?
The analysis specified in the agreed proposal.
How or where can data be obtained?
Emailing principal investigator: v.palmer@unimelb.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8081Ethical 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.