A virtual DigiCare4You kick-off meeting was held on April 8th-9th 2021. The participants included Privanova, representatives of the European Commission and an international, multidisciplinary consortium of 16 partners (from Europe, USA and Australia), including the key partners who developed and implemented the Feel4Diabetes-study and BlueStar®.
The meeting marks the official start of the EU-funded DigiCare4You project which will deliver an intersectoral innovation involving digital tools for early screening, prevention and management of type 2 diabetes and hypertension.
DigiCare4You – About the project
DigiCare4You Consortium will jointly work with local stakeholders to deliver an intersectoral innovation involving digital tools for early screening, prevention and management of type 2 diabetes (T2D) and hypertension (HTN). An implementation study will be conducted, targeting more than 10,000 families in two Middle Income Countries (Albania and Bulgaria) and two High Income Countries (Greece and Spain), considering vulnerable groups.
Schools will be used as an entry point to the community and building on an existing procedure for children’s periodic growth assessment (conducted via school nurses or in collaboration with local community health centres), parents/ caregivers will be screened via a non-invasive self-reported digital screening tool. Those identified at high risk for T2D will be referred for glycaemia testing and blood pressure (BP) measurements at local community health centres. Parents/ caregivers confirmed to have pre-diabetes or diabetes (and possibly high BP) will be invited to join a mHealth self-management intervention coordinated by the community healthcare workforce.
The goal of this intervention is not only to improve the health status of the users, but also empower the entire family in adopting a healthy lifestyle. To this end, schools and communities will also be actively engaged to:
- promote health literacy,
- well-being and;
- support lifestyle changes creating a more supportive social and physical environment for the entire community.
Regular monitoring will be ongoing during the implementation to allow corrective actions and ensure effective adaptation and uptake.
Based on the study outcomes, the in-depth health economic evaluation and budget impact analysis, and data deriving from a Scalability Assessment and Decision-Support tool, national and international stakeholders will be invited to evaluate, through a series of webinars and workshops, the scalability potential of the DigiCare4You solution in other regions or countries in Europe.
DigiCare4You – Privanova’s role
The nature of the research as well as the sensitivity of the data DigiCare4You will process requires that all potential ethics, privacy and overall compliance issues that might arise within the project be addressed from the outset. Experienced in ensuring compliance in other health-related projects such as AI4HealthSec, Privanova also have extensive hands-on-business knowledge of tackling issues related to the processing of personal data and the ethical use of Artificial Intelligence. In this context, Privanova is the leader of Work Package 3, which is fully dedicated to legal and ethics compliance of the project.
The project received a Conditional Ethics Clearance and was assigned a number of ethics requirements. Our task will be to assist the coordinator in responding to Ethics requirements received as part of the EC’ Ethics Appraisal Procedure. We will identify the legal and ethical framework applicable to the project, assist the partners in its implementation and monitor compliance. This will be achieved by translating the received Ethics requirements into actionable items for the consortium partners to understand and implement.
We also aim to ensure compliance of the research procedures and outcomes with the applicable legal framework including especially GDPR. This will include the consortium efforts on defining the Data Management Plan and contributing to the project’s risk management component. This will be executed by identifying and addressing any potential risks for privacy and personal data of individuals during the project life cycle. It will be implemented by translating legal concepts nto actionable requirements that will be executed within the development, adaptation, implementation and evaluation of the DigiCare4You innovative solution.
Establish the Ethics Advisory Board which will consist of several independent ethicists with relevant expertise. The EAB will ensure continuous compliance of our communication, dissemination and exploitation activities, support the coordinator by providing ad-hoc advice and contribute to Ethics & Compliance Reports.