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van CCT (UK)

van CCT (UK)

Effectiveness of currently available cardiac rehabilitation programmes from 8 European institutes in elderly patients.

- candidate number22468
- NTR NumberNTR5306
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jul-2015
- Secondary IDsMETC: 15.0350 CCMO: NL52816.075.15
- Public TitleEffectiveness of currently available cardiac rehabilitation programmes from 8 European institutes in elderly patients.
- Scientific TitleThe (cost) effectiveness, sustainability and participation levels of current EUropean Cardiac Rehabilitation programmes in Elderly: a prospective cohort study.
- ACRONYMEU-CaRE observational study
- hypothesisNull hypothesis: the 8 centres with different cardiac rehabilitation (CR) programmes do not differ from each other with regards to the effectiveness.
- Healt Condition(s) or Problem(s) studiedCardiac rehabilitation
- Inclusion criteriaIn order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients of 65 years or older who have accepted CR
- Signed written informed consent
- One of the following criteria:
o Patients with an ACS, including MI and/or revascularisation within 3 months prior to the start of the CR programme
o Patients that underwent a PCI within 3 months prior to the start of the CR programme
o Patients that received CABG within 3 months prior to the start of the CR programme
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindication to CR
- Mental impairment leading to inability to cooperate
- Severe impaired ability to exercise
- Signs of severe cardiac ischemia and/or a positive exercise testing on severe cardiac ischemia
- Insufficient knowledge of the native language
- Implanted cardiac device (CRT-P, ICD)
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-aug-2015
- planned closingdate1-jun-2019
- Target number of participants1760
- InterventionsNot applicable.
- Primary outcomeDifference in peak oxygen uptake (VO2peak) between the end of CR programme (T1) and baseline (T0).
- Secondary outcome- Difference in VO2peak between 12 months (T2) and T0
- Difference in VO2peak between T2 and T1
- Traditional risk factors for CVD
- Major Adverse Cardiovascular Events (MACE)
- General health
- Care utilisation
- Costs of care utilisation
- Adherence
- Compliance
- TimepointsPatients will be monitored at
T0: start of CR programme
T1: end of CR programme
T2: after 12 months
- Trial web site
- statusplanned
- Sponsor/Initiator Isala Clinics Zwolle
- Funding
(Source(s) of Monetary or Material Support)
European Union, Government of Switzerland
- Publications
- Brief summaryCardiovascular diseases (CVDs) are still the leading cause of death in Europe and a major cause of disability and loss of productivity in adults worldwide, this comes down to more than 4 million deaths each year in Europe. The substantial burden of CVD is further exemplified by a huge economic strain. Costs of CVD in the European Union (EU) are estimated at 169 billion annually, with healthcare costs accounting for 54% of the costs. Literature shows that cardiac rehabilitation (CR) is highly effective, but knowledge on the effectiveness of individual CR components and appropriateness for specific patient groups is limited. With the ageing population and high survival rates from CVD due to improved technologies, there is growing need to a more tailored approach for different patient groups, like the elderly, within cardiac care. CR is currently underused by elderly and the effects of these programmes are underestimated by professionals. This group of people is often characterised by physical impairment, comorbidities and reduced mobility. The current approach of CR is often less appropriate for the elderly, and as a result of which effectiveness, compliance, participation levels and cost-utility of CR programmes is hampered.

Therefore the aim of this observational study is to obtain the evidence base to improve CR programmes regarding sustainable effectiveness, cost-effectiveness and participation level in elderly patients, by comparing 8 currently available CR programmes. The sustainability of CR programmes will be analysed by adding a follow-up period after the end of the regular CR programmes.
- Main changes (audit trail)29-sept-2016:
Amendement 1.
Inclusion NEW:
o Patients who were treated surgically or percutaneously for valvular heart disease (including TAVI) within 3 months prior to the start of the CR programme
o Patients with a stable angina with documented significant CAD (defined by standard non-invasive or invasive methods)
- RECORD16-jul-2015 - 29-sep-2016

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