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EU-CaRE Report Summary

Project ID: 634439
Funded under: H2020-EU.3.1.

Periodic Reporting for period 1 - EU-CaRE (A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly)

Reporting period: 2015-05-01 to 2016-10-31

Summary of the context and overall objectives of the project

Improving the quality of life and independence of elderly heart patients is a major challenge in Europe. Cardiovascular diseases lead, each year, to more than four million deaths in Europe. The disease burden of cardiovascular disease is a also a major problem, especially in the elderly. Due to the ageing population, the number of elderly cardiac patients will rise further in the coming decades and exert additional pressure on the healthcare system.

The EU-CaRE project
A network of leading heart centers and top research institutes from seven European countries started May 1st 2015 to compare, improve and tailor cardiac rehabilitation programmes for the elderly.
This project is called EU-CaRE which stands for “a EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly” and has as main objective improvement of the quality of life and independence of elderly heart patients.
EU-CaRE must lead to new guidelines and treatment protocols. In addition, it must put the brakes on the impending explosion of billions of Euros in health care costs for this patient group.

Additionally, a randomised controlled trial (RCT) is conducted in patients who do not volunteer to participate in the conventional CR programme in the observational study, but do volunteer to join a mobile telemonitoring guided programme (mCR). The patients will be randomised in two study arms:
1) join mCR programme for 6 months
2) no mCR programme

General objectives of EU-CaRE:
To compare the effectiveness of currently available CR programmes from 8 European institutes in the elderly (>65 year) population, by collecting relevant data, and analysing and reporting results.
To assess whether mCR as alternative for patients who refuse joining a conventional CR programme is an effective means to increase participation and adherence of elderly patients in a CR programme, and results in better long term patient outcomes than the patients who do not follow the mCR programme.
To determine the main preconditions for sustainable effective CR programmes in the elderly, mainly related to lasting improvement of the physical condition, but also related to risk factors, general health (mental health and quality of life), and health care utilization
To analyse the induced and avoided costs and revenues of CR and mCR programmes to determine the cost effectiveness of different approaches
To define the core components for effective recruitment of CR programmes and analyse the impact of mCR on participation grade.

EU-CaRE Partners
Isala (The Netherlands), RegionH (Denmark), APHP (France), UBERN (Switzerland), IHF (Germany), SERGAS (Spain), AOP (Italy), Diagram (The Netherlands), SUR (Italy) and MobiHealth (The Netherlands).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The first patient included in the observational study by the first centre (ISALA) was achieved on September 3, 2015. Until October 31, 2016, 635 patients are enrolled in the observational study.
The first patient included in the RCT by the first centre (ISALA) was achieved on November 11, 2015. Until October 31, 2016, 59 patients are enrolled in the RCT which is 25% of the total inclusion.

The EU-CaRE website went online at October 22, 2015. Several presentation at international and national levels were held:

• Presentation of the project to the Cardiac Rehabilitation board of European Association of Preventive Cardiology (European Society of Cardiology) : Salerno, October 16, 2015
• Preventive Cardiology, sports cardiology and exercise based rehabilitation: European Society of Cardiology : Bern , November 10, 2015 ( presentation of the project (main session)
• Third European Congress on eCardiology and eHealth. Berlin October 26-28, 2016. Poster entitled: A European randomized controlled trial for an eHealth application in cardiac rehabilitation in the Elderly. A van der Velde, Prescott E, Wilhelm M, et al.

• France: French working Group of cardiac rehabilitation, exercise and Sports: Arcachon, September 1-3, 2015 (main session); Georges Pompidou hospital, Paris November 6, 2015
• Portugal: Cardiology seminar: Coimbra, September 16, 2016 Presentation by Spain team.
• Spain, Germany and the Netherlands: The Dutch public media (NOS) paid attention to the launch of this international project on both radio and in newspapers. In addition, there was also attention to EU-CaRE within the regional press around Zwolle. The EU-CaRE project was presented at the Cardiothoracic surgery symposium at ISALA at September 17, 2015.
• Spain and Germany: There was attention for EU-CaRE within public magazines, journals, TV and on social media activities

Furthermore 2 scientific papers were released and a poster was presented:
A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial. Prescott E, et al. European Journal of Preventive Cardiology. 2016, Vol. 23(2S) 27–40

Participation and adherence to cardiac rehabilitation programs. A systematic review. Ruano-Ravina A et al, . Int J Cardiol. 2016 ;223:436-443.

Poster presentation
A European randomised controlled trial for an eHealth application in cardiac rehabilitation in the elderly – study design and intermediate results of EU-CaRE RCT; van der Velde AE, Prescott E, Prins LF, Wilhelm M, Iliou MC, Peña Gil C, González-Juanatey JR, van ’t Hof AWJ, de Kluiver EP; 3rd eCardiology and eHealth congress; Berlin, Germany; October 26-28, 2016

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

EU-CaRE is aimed to provide the evidence base for the development of more effective cardiac rehabilitation interventions, and for enhanced uptake, adherence and compliance in the elderly population. In addition to safety and efficacy information, health economic and outcomes research data are also part of the research project (health technology assessment). More specifically, EU-CaRE relates to the three impacts set out in the work programme:
1. Improvement of individual patient outcomes and health outcome predictability through tailoring of Interventions
2. Improvement of guideline development for diseases and the management of comorbidities
3. Support to regulatory guidance in this population and provision of more accurate information to patients and prescribers

Expected impact on any other environmental and socially important impacts
The cost of informal care for people with CVD in the EU is important non-health care cost. For the estimated annual costs for CVD in the EU of €196 billion, 22% of the costs is related to informal care of people (reference European Heart Network and European Society of Cardiology, European Cardiovascular Disease statistics 2012 edition, September 2012). As the number of patients, in particular elderly patients, is expected to rise due to an ageing society, the costs of informal care are likely to rise further, if no improvements in the current care provision are realised. As mentioned before EU-CaRE aims at improving not only the CR programmes especially for the elderly, but also the adherence and compliance to these programme.
With an expected increase from 50% to 70% of the patients showing sustainable effectiveness and an absolute increase in participation of 25% a significant number of patients will need less informal care leading to a significant reduce of cost related to informal care.

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