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

Not Applicable

Recruiting

• Conditions: COVID-19; Mental Health; Respiratory - Other respiratory disorders / diseases; Mental Health - Depression; Mental Health - Anxiety; Cardiovascular - Other cardiovascular diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12620000640909
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-01
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[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.];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.<br><br>[Data will be analysed daily for 14 days]

Secondary Outcome Measures

Name	Time	Method
ser 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.[Approximately 4 weeks post CovidCare app download];Depression scores as determined by responses to PHQ-2.[Baseline (day of app download), and Day 14 and Day 28 after baseline];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.[Approximately 4 weeks post CovidCare app download];Anxiety screening scores as determined by responses to the GAD-2[Baseline (day of app download), and Day 14 and Day 28 after baseline]