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

Middlemass, Jo, Siriwardena, A. Niroshan, Pompilio, Pasquale , Isetta, Valentina, Munaro, Giulia, Castellani, Angelo P., Macis, Roberta, Zanaboni, Paulo, Calverley, Peter M., Dellaca, Raffaele, Rosso, Roberto, Windle, Karen, Vos, Jolien, Dalmases, Mireia, Janson, Christer and Malinovschi, Andrei (2014) Clinical trials for elderly patients with multiple diseases (CHROMED) pilot study. In: Society for Academic Primary Care 43rd Annual Conference, 9-11 July 2014, Edinburgh.

Clinical trials for elderly patients with multiple diseases (CHROMED) pilot study
SAP2014Chromedpilot.pdf - Presentation
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Item Type:Conference or Workshop contribution (Presentation)
Item Status:Live Archive


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 ( 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).
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.
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.

Additional Information:
Keywords:multimorbidity, Chronic Obstructive Pulmonary Disease, telemedicine, randomised controlled trial, pilot study
Subjects:H Engineering > H123 Public Health Engineering
A Medicine and Dentistry > A300 Clinical Medicine
Divisions:College of Social Science > School of Health & Social Care
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ID Code:16675
Deposited On:12 Feb 2015 14:38

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