Clinical Trials for Elderly Patients with Multiple Diseases (CHROMED)

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Project title	CLINICAL TRIALS FOR ELDERLY PATIENTS WITH MULTIPLE DISEASE (CHROMED)
Funding body	European Commission and Euratom Treaties funded under the 7th Framework Programmes (FP7-HEALTH-2012-INNOVATION-1) Project number 306093
Total funding	€2,563,530.75
Team/consortium	TESAN S.P.A., Italy Restech SRL – Del Politcnico Di Milano, Italy The University of Liverpool, United Kingdom Tallina Tehnikaulikool, Estonia Universitat De Barcelona, Spain Uppsala Universitet, Sweden Universitetssykehuset Nord-Norge HF, Norway Community and Health Research Unit (CaHRU), University of Lincoln, United Kingdom (Professor Niro Siriwardena and Dr Jo Middlemass). Also colleagues from Lincolnshire Community Health Services. Bolnisnica Sezana Zavod, Slovenia.
Overarching aim	The aim of the CHROMED project was to evaluate the impact of adopting an electronic monitoring system to support elderly patients with a combination of chronic diseases including respiratory and cardiovascular systems, in their own homes.
Objectives	To develop and evaluate clinical protocols and organisational models based on the new telemonitoring technologies in order to improve both quality of life and healthcare costs associated with elderly patients with multiple diseases.
Methods	Feasibility study leading to a full scale study which included: Customisation and adaptation of the technological infrastructure in patients’ own homes. Conducting a feasibility study on 20 patients in 3 centres of which 5 patients will be recruited from Lincolnshire. The purpose of the feasibility study is to test the systems and the protocol for the main study. Qualitative feedback from users to inform possible enhancement of the system. Full randomised controlled trial with 300 patients, of which 32 were to be recruited from Lincolnshire. Utility measure (EQ-5D3L) administered before and after the study. Measures throughout the study included, service use, symptoms checklist, hospital admissions, length of stay and readmissions.
Outcomes	An increased knowledge of chronic obstructive pulmonary disease (COPD) and its interaction with other comorbidities including congestive heart failure (CHF). An increased objective knowledge on the development of exacerbations in COPD. A validated clinical protocol and organisational model for telemedicine in COPD with common comorbidities (CHF and sleep disorders). An economic and clinical evaluation of the impact of electronic monitoring for elderly patients with COPD and other comorbidities.
Outputs	Dissemination of scientific evidence of project results to relevant healthcare communities including theUKand the rest ofEurope. A new system and ICT platform and the development of clinical guidelines that will be immediately available. Peer reviewed publications: Walker PP, Pompilio PP, Zanaboni P, Bergmo TS, Prikk K, Malinovschi A, Montserrat JM, Middlemass J, Šonc S, Munaro J, Marušič D, Sepper R, Rosso R, Siriwardena AN, Janson C, Farre R, Calverley PMA, Dellaca RL (2018).Telemonitoring in COPD: the CHROMED study, a randomized clinical trial. American Journal of Respiratory and Critical Care Medicine (AJRCCM) 198 (5): 620-628. Middlemass JB, Vos J, Siriwardena AN (2017). Perceptions on use of home telemonitoring in patients with long term conditions – concordance with the Health Information Acceptance Model: A qualitative collective case study. Medical Informatics and Decision Making 17:89. Pompilio P, Isetta V, Malinovschi A, Middlemass, Jo, Munaro G, Dalmases M, Janson C, Siriwardena, A. Niroshan, Macis R, Zanaboni P, Calverle PM, Dellaca R, Rosso R (2014) Clinical trials for elderly patients with multiple diseases (CHROMED): a pilot study. The European Respiratory Journal, 44 (Supp58): 971. Pompilio P, Macis R, Isetta V, Munaro G, Walker P, Castellani AP, Dalmase M, Middlemass J, Siriwardena AN, Zanaboni P, Sepper R, Prikk K, Malinovschi Andrei, Janson C, Marušiç D, Dolgan T, Dellaca RL, Calverley PMA, Rosso R, (2015) Lung function assessed by home forced oscillation and self reported symptoms during COPD exacerbations. European Respiratory Journal , 46 (Supp59): 5.2. Conference presentations: Middlemass J, Siriwardena AN, Pompilio P, Isetta V, Munaro G, Castellani AP, Macis R, Zanaboni P, Calverley PM, Dellaca R, Rosso R, Windle K, Vos J, Dalmases M, Janson C, Malinovschi A. 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.. In: Society for Academic Primary Care 43rd Annual Conference, 9-11 July 2014, Edinburgh University, Scotland.
Impact	The main impacts are expected to be: Clinical-medical: prevention and early detection of exacerbations for conditions such as COPD and CHF leading to improved self management and more timely medical intervention. Economic: potentially a decrease in the need for unnecessary emergency hospitalisation leading to reduction in health care costs associated with these comorbidities. Social: prevention of chronic disease has enormous impact to society costs and wellbeing especially in elderly people.

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