COTIDIANA is an european project funded by the Active Assisted Living Programme (AAL-2020-7-146-CP). Its main goal is to develop a mobile solution to support clinical care and drug trials of older adults with rheumatic conditions.

Motivation

The motivation for the project stems from the increase in the number of patients with rheumatic conditions and the difficulties in accompanying patients’ symptoms, in both clinical care and drug trials. Existing solutions are not cost-effective, since they are:

  • restricted to self-reported data, leaving behind digital endpoints;
  • difficult to use by patients, which affects mostly older adults with less ICT experience;
  • targets specific care focuses (e.g. clinical care OR drug trials) disregarding the ecosystem nature of care;
  • are not focused on rheumatic diseases.

Approach

COTIDIANA project will be co-designed with end-users and stakeholders. The project starts with ethnographic and participatory research with with patients, clinicians, as well as with a broad group of stakeholders which include clinical researchers, people from Pharma, or Clinical Research Organizations. Laboratory data collections with patients will also be planned and performed, for training passive sensing algorithms and crafting digital endpoints. In parallel, the project will develop a mobile app for patients and a web app for clinicians and clinical researchers. The developed solution will be assessed in three field trials, one of which focused on technological feasibility and the two others focused on clinical care and clinical research or drug trials.

At this point, we are working mostly with osteoarthritis, rheumatoid arthritis, and psoriatic arthritis, some of the most common rheumatic conditions. In Austria we will involve people with Sjögren Syndrome.

Following a successful project, the COTIDIANA solution will be commercialised by two companies from the consortium, providing hospitals, clinics, and Pharma, with a solution that provides rich data about the current health state of their patients with rheumatic conditions.

Consortium

The COTIDIANA project is being pursued by a consortium of six institutions, covering expertise in technological development, rheumatology, User-Centred and Participatory Design, and business. The project partners are:

Fraunhofer Portugal AICOS (coordinator) is an applied research centre focused on supporting industry through research- and technology-based innovation, namely in the healthcare sector. The centre has a strong track record of co-designing technologies to support health condition monitoring and self-care of older people living with chronic conditions. Main research areas are Human-Centred Design, Artificial Intelligence, and Cyber-physical systems. https://www.aicos.fraunhofer.pt

Definition12 AG is an SME specialized in engineering and distribution of medical mobile applications. Founded in 2000, the company started developing medical products for smartphones and tablets early on and was the first swiss company to use iPads for multi-center, global, clinical trials, in pharmaceutical phase III studies. This particular system was used in more than 30 countries and 450 hospitals, successfully collecting +100’000 patient records. Currently, Defintition12 is developing a tele-rehabilitation product for stroke patients in cooperation with the University of Bern. Moreover, Definition12 distributes its own products in the area of emergency / rescue medicine and breast cancer. https://www.definition12.com

Mag. Andreas Raffeiner GmbH is an Austrian CRO, specialized in project management and monitoring of clinical trials on medicinal products for human use. RAFFEINER strives for ongoing improvement and extension in quality and expertise in current and new business areas. Highly qualified staff, customer-tailored solutions and personal commitment have been well-known advantages of the company ever since launching in 2002. RAFFEINER develops and commercialises the Studymate Pro, an electronic Case Report Form, that gathers data from drug trials and can be delivered to drug regulators (e.g. EMA). https://www.studien-monitor.at

Medizinische Universität Wien founded in 1365 as Medical Faculty and independent since 2004, is one of the most traditional medical training and research facilities in Europe. With 26 university hospitals, 3 clinical institutes, 12 theoretical medicine centres and numerous highly specialised laboratories, it is one of the cutting-edge research institutes of Europe in biomedicine. Together with General Hospital (AKH) MUW is the largest health institution in Austria with > 120.000 inpatients and 530.000 outpatients treated each year. The Section for Outcomes Research (OR) has an outstanding track record in innovative research methodology including patient-reported outcomes, advanced psychometrics, clinical trials, qualitative studies, mixed methods, assistive/digital technologies and collaborative medical research. https://cemsiis.meduniwien.ac.at/en/or/

Pryv SA is a Swiss SME and leading market provider of privacy and personal data management software. Pryv delivers essential software for data-driven healthcare innovation which helps organizations manage personal data from creation to use, sharing and disposal. Pryv.io is an open source and extensible personal data lifecycle management platform that reduces time to market, cuts IT development costs, and speeds-up connectivity to any data source. Pryv addresses the enhanced citizen’s right under GDPR and turn privacy compliance into a competitive advantage. Pryv’s mission is to set-up the standard for exchanging sensitive personal and health data with full respect for privacy and allow for the design of scalable products without limitation to borders and legal environments. https://www.pryv.com

Comprehensive Health Research Centre (CHRC) is a research center of NOVA Medical School (NMS), NOVA University of Lisbon. NMS is associated with several health units, allowing a variety of teaching environments and a more comprehensive knowledge of hospital reality and primary health care. CHRC is a multidisciplinary, multi-institutional and comprehensive new research centre, rated as Excellent by the National Foundation for Science and Technology. The centre has expertise in surveys, chronic disease registries, observational studies and management of large databases including a wide range of data: demographic, life habits, clinical, pharmacological, socio-economic, quality of life (QoL), imaging, genetic and laboratorial data. The centre has made a long-term investment in a population based longitudinal cohort with imaging and blood samples. The team is also committed and has a vast experience in conducting interventional strategies and studies using information and communications technology (ICT, internet, apps and smart TV tools). https://www.chrc.pt