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

The problem COPD (Chronic Obstructive Pulmonary Disease) is a significant socioeconomic burden which, particularly when associated with comorbidities such as Chronic Heart Failure (CHF), markedly affects patient outcomes. Care models based on telemedicine systems that enable early diagnosis and treatment of exacerbations are advocated to reduce the impact of chronic diseases on patient outcomes and health service costs. CHROMED (www.chromed.eu) is an international EU-funded project aimed at developing a multi-centre clinical trial to evaluate the impact of a new integrated home care approach to reduce care costs and improve quality of life in COPD. The approach We collaborated in a pilot study prior to the main trial which will include 300 patients from seven European countries (Italy, Spain, UK, Estonia, Slovenia, Sweden and Norway) with nine partners. The home monitoring system includes a novel forced oscillation technique (FOT) device for self-measurement of lung mechanics (RESMONPRO DIARY, Restech srl, Italy), a touch screen for collecting patients' symptoms and, where COPD is associated with CHF, by a device for measuring heart rate (HR), blood pressure (BP), pulse oximetry (SpO2) and body temperature (WRIST CLINIC, Medic4all, Israel). Findings The pilot included 16 patients (n=11 COPD, 5 COPD+CHF). The average monitoring period was 48.3±23.4 days resulting in a total of 504 patient days. The percentage of data correctly received within the period was: lung impedance and breathing pattern 90.0%; HR 91.7%, BP 91.7%; SpO2 74.0% and body temperature 71.4%. During the pilot, one patient was treated pharmacologically for an exacerbation of COPD. Offline processing demonstrated that the system identified warning of an exacerbation five days prior to admission. We also analysed qualitative data from patients and professionals about the acceptability of the telemedicine system and the interaction between patients, professionals and the monitoring system. Consequences The data suggest good acceptability and short-term compliance among patients with COPD. Lung function, HR and BP provided the most reliable data. The full RCT is currently under way and will be completed in August 2015

Lung function assessed by home forced oscillation and self reported symptoms during COPD exacerbations

CHROMED (clinical trials for elderly people with multiple diseases, www.chromed.eu) is an EU-funded project involving 9 partners from 7 European countries aimed at evaluating the impact of a new home care approach to reduce costs and improve quality of life in elderly patients with COPD and comorbidity. The trial involves 300 patients with a prior history of exacerbations randomly assigned to a monitoring or observational arm. Monitored patients performed daily self-assessment of lung mechanics with a FOT (Forced Oscillation Technique) device (RESMON PRO DIARY, Restech srl, Italy) and completed a symptom diary card on touchscreen device (HOME PATIENT MONITOR, EBM srl, Italy). Any detected worsening in lung mechanics generated an alert triggering a phone interview directed at verifying the patient's status and optimizing treatment. By the end of March 2015, 70 monitored patients had completed the trial resulting in 16198 measurements with an adherence of 90.1%. Based on lung mechanics, 311 worsening events were detected, resulting in 0.65±0.3 alerts/patient/month. At least one major symptom (dyspnea, sputum purulence and volume) was reported in 70% of events and 41% were associated with an exacerbation according to diary cards (Seemungal et al., Am J Respir Crit Care Med 1998). A total of 77 exacerbations were confirmed during the phone interview and treated, but 48% of them were not associated with an exacerbation defined by diary cards only. These results suggest that a significant percentage of exacerbations cannot be identified by diary cards only. Self-assessment of lung mechanics using FOT provides complementary information which can be useful to manage COPD patients at home

Randomised controlled trial of telemonitoring with addition of daily forced oscillation in older people with COPD and co-morbidity

Evidence of clinical benefit and cost-effectiveness from daily symptom and simple telemonitoring in COPD is unproven. The CHROMED study explored the effect of telemonitoring in older people with COPD and significant co-morbidity who performed daily forced oscillation measurements via RESMON PRO DIARY to identify early physiological change associated with an exacerbation. Six centres in 5 countries randomised 312 people to 9 months telemonitoring (154) or daily symptom questionnaires (158). Each day the monitored group recorded symptoms, pulse, BP, oxygen saturation and airway resistance and reactance. An alert was generated if results exceeded pre-determined parameters and the participant was contacted by their local clinical centre to consider additional treatment. Baseline characteristics were evenly matched: mean age 71 years, FEV1 1.3L (50% predicted) and SGRQ score 49. 61% of subjects had 2+ exacerbations and 42% had been hospitalised in the previous year. Time to first hospitalisation did not differ albeit the monitoring group had fewer hospitalisations (79 vs 103; p=ns) and days in hospital (329 vs. 650; p=ns). However, subjects hospitalized with an AE COPD in the previous year (n=128) had a lower hospitalisation rate (p<0.04). Quality of life (EQ-5D) and health status (CAT) did not differ between groups. Mean cost in the monitored group was marginally lower (€4,615 vs €4,831; p=ns). Telemonitoring including daily forced oscillation impacted neither time to first hospitalisation nor health status. Reduction in hospitalisation rate in subjects with previous hospitalisation suggests these individuals may benefit from telemonitoring and earlier treatment