Chronic obstructive pulmonary disease (COPD) is a highly prevalent chronic condition. While COPD is a lung disease, it is mainly the exacerbations and extrapulmonary comorbidities which affect the quality of life, health care costs, and prognosis. The optimal COPD treatment needs to focus on both the characteristics and consequences of the lung disease itself and the diagnosis and treatment of comorbidities. While the severity of lung function impairment is routinely assessed, the exacerbations, the associated comorbidities and limitations in daily life are still significantly underestimated. A personalized approach to COPD management is needed to specifically address the disease, prevent exacerbations, and mitigate its comorbidities to obtain a positive impact on patient health and quality of life. TOLIFE will clinically validate an artificial intelligence (AI) solution to enable optimised and personalised treatment and improved quality of life in COPD patients. TOLIFE will process daily life patient data captured by non-invasive smart sensors (smartwatch sensors, smartphone sensors, smart mattress cover, smart-shoes, web services for meteorological conditions and environmental quality) to predict exacerbations, assess the patients’ health outcomes and characterize the patient health status. The TOLIFE personalized approach to COPD management will be based on exacerbation prediction, continuous assessment of health status and patient characterization enabled by the analytics tools that will feed the TOLIFE software interfaces: the Patient Management Tool (PMT) and the Disease Information Tool (DIT). The algorithms for exacerbation prediction, assessment of health outcomes and patients’ characterization (i.e. the analytics tools) will be developed pursuant to the data collected in Clinical Study A (smart sensors data and clinical references). The effectiveness of the TOLIFE approach (i.e. to reduce exacerbation events and to improve health-related quality of life) will be evaluated through the clinical study B where clinicians will treat the patients with the support of the PMT, while the patients will use the DIT. In the clinical study B, we will compare the COPD progression, in terms of exacerbations and health related quality of life, between a group assigned to usual care and the TOLIFE group. Smart sensor data and clinical data collected in the clinical studies will be stored in a dedicated cloud platform. The platform will collect data from the smart sensors and the clinical data of the periodic follow up of the patients in the hospital. TOLIFE will also perform a SWOT survey to collect priorities perceived by the Consortium Partners and by a small sample of expert patients as strengths, weaknesses, opportunities and threats of the TOLIFE technology and system. Those priorities will integrate and complete the set of priorities which will be examined to perform the multi-domain assessment of the TOLIFE system.
