Clinical trials for elderly patients with multiple diseases (CHROMED): A pilot study

Chronic Obstructive Pulmonary Disease (COPD) is a significant socio-economic burden. It is frequently associated with comorbidities, such as Congestive Heath failure (CHF), that affect patients' health outcomes. Telemedicine-based care models that enable early diagnosis and treatment are advocated to reduce the socioeconomic impact of chronic diseases. CHROMED (www.chromed.eu) is an EU-funded project involving 9 partners from 7 European countries (Italy, Spain, UK, Estonia, Slovenia, Sweden and Norway) aimed at evaluating the impact of a new integrated home care approach to reduce care costs and improve quality of life in COPD. CHROMED comprises a pilot study, followed by a multi-centric RCT with 300 patients. The CHROMED system includes a forced oscillation technique (FOT) device for self-measurement of lung mechanics (Resmon Pro Diary, Restech srl, Italy), a touch screen for collecting patient's symptoms and, for subjects with CHF comorbidity, a device for measuring heart rate (HR), blood pressure(BP), SpO2 and body temperature (WRIST CLINIC, Medic4all, Israel). The pilot study included 16 patients (11 COPD, 5 COPD+CHF). The average monitoring period was 48.3±23.4 days resulting in a total of 504 days. The percentage of data correctly received is reported in the table. Lung impedance and breathing pattern 90% Heart rate 91.7% Blood pressure 91.7% SpO2 74% Body temperature 71.4% During the pilot, one patient was treated pharmacologically for a COPD exacerbation. Offline processing demonstrated that the system identified this event 5 days in advance. A good acceptability of the system and short-term compliance among patients was found. Lung function, HR and BP provided the most reliable data.