The work packages
The aim of WP1 is to tailor an existing remote monitoring infrastructure (the Ava bracelet, app, data analysis, computer algorithms, and APIs) from its original (pre-project) application to the application of COVID-19 remote monitoring. To address this aim, we have devised the below sub-objectives.
- Modify Ava monitoring device output and data analysis process for detection of changes in physiological parameters that could be indicative of COVID-19 infection.
- Develop a novel app based off Ava’s existing architecture that gathers baseline data, clinical symptoms, biophysical parameters and potential exposure status that then transfers this raw data to a backend server for processing and sends algo-derived testing recommendations back to the user in real-time.
- Build a machine learning algorithm based on data from the wearable device, clinical symptoms and risk class to adjudicate participants to testing for SARS-CoV-2.
- Build and maintain a GDPR-compliant infrastructure for extracting, cleaning, storing, analyzing and transferring data from deployed measurement technologies in conjunction with WP5.
The following objectives have been identified as part of the WP2:
- Develop protocols and procedures for study participant testing in the cohort study;
- Test study participants who have a positive signal using the algorithm developed in WP1 for SARS-CoV-2 virus;
- Test all study participants for SARS-CoV-2-specific antibodies at the end of their follow-up period, and if positive, also test their stored baseline samples;
- Collect information on positive cases and their clinical follow-up;
The objective of WP3 is to evaluate the ability of the Ava Bracelet when coupled with a signs and symptoms diary to detect early indicators of COVID-19 infections accurately and reliably enough to be used to make early triage recommendations regarding need for further testing and treatment.
- Develop study protocol for cohort study;
- Acquire relevant approvals (including feasibility of e-consent/data privacy issues);
- Analyse data from study and interpret results;
- Develop advice for further use of tested approach;
- Health economic analysis;
- Pilot testing;
- Full study execution including recruitment of participants;
The objective of WP4 is to explore the health economics of the AVA monitoring device for SARS-CoV-2 detection. This will include collection of data related to use of healthcare resources for both the AVA monitoring device and in the hospital system. Moreover, a cost-consequence analysis will be performed to relate the incremental costs to the clinical advantages of the AVA monitoring system.
- To assess the costs of implementing and operating the AVA monitoring device;
- To assess the economic outcomes of the monitoring device;
- To assess the monitoring device using a cost-consequence analysis;
WP5 will develop a full ‘data management plan’ (DMP) as well as a data sustainability plan. The overall objective is to provide an infrastructure to host all data, or features extracted from the data, collected and analysed in the study with the same level of annotation, pseudo-anonymization and accessibility for model development as during the research phase. The plan should comprise financial, legal, ethical and structural aspects as well as scalability of the storage/access capacity. For WP5, we have devised the following sub-objectives:
- Develop electronic questionnaire(s) capturing individual subject signs and symptoms longitudinally directly from the patients;
- Develop case report forms (CRFs) to capture additional data as collected/or available by the site for each patient including baseline demographics, baseline comorbidities, baseline COVID risk factors, PCR results, chest CT results, serology results, health resource utilization, adverse events, and clinical outcomes;
- De infrastructuur creëren voor het organiseren van gegevens over verschijnselen en symptomen, CRF-gegevens en apparaatgegevens (of geparametriseerde resultaten uit de apparaatgegevens);
- Implement a long-term, sustainable model for data storage meeting FAIR requirements;
WP6 will work to serve the needs of the project acting as a facilitator of the work, connecting information sources from key stakeholder groups to improve the value, quality and harmonization of information disseminated on evidence related to COVID-19 remote monitoring and its utility in early detection of illness incidence and triage decisions. The aim of WP6 is to help maximize the impact of project outcomes on stakeholders.
- Identify and incorporate stakeholders’ perspectives on the barriers and enablers of remote monitoring devices and apps for monitoring physiological parameters in detecting early signs of a COVID-19 infection into project roadmap.;
- Development and execution of an appropriate regulatory strategy;
The objective of WP7 is to run effective project management for the COVID-RED consortium and to guarantee the project’s capacity to respond to the urgent need for remote detection of COVID-19, and to facilitate an improved understanding of the spread of and capacity to remotely detect COVID-19.
- Project management: Providing detailed follow-up and tracking, via regular work package reports, early reports of any unexpected organisational or structural issues or delays with respect to the project deployment and intermediate objectives;
- Set-up an effective communication infrastructure and foster the integrative process within the consortium;
- Ensure the consortium’s contractual duties are carried out. Advise and guide the participants to comply with the IMI regulations and their contractual and legal requirements. Abide by the "good practice" of resources management as presented in the Financial Guidelines;
- Prepare and execute a sustainability plan, to ensure the most efficient exploitation of project results and to achieve the highest possible benefit for scientists, industry and the European society;
This work package sets out the 'ethics requirements' that the project must comply with.