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The effects of a mobile telemonitoring guided cardiac rehabilitation programme (mCR) versus no cardiac rehabilitation in elderly patients in Europe.

‘Randomised Controlled Trial for an eHealth application in European Cardiac Rehabilitation programmes in Elderly; Assessment of the effects on sustainability and participation level of a mobile telemonitoring guided cardiac rehabilitation programme (mCR) and its cost effectiveness, in elderly patients in Europe’

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24643
Enrollment
238
Registered
2015-07-16
Start date
2015-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac rehabilitation, eHealth

Interventions

Patients aged 65 years and older, who are candidate for CR, but nut opting for regular CR are randomised in two study arms: the mCR programme for 6 months or no mCR programme. The mCR programme involv

Sponsors

Isala Zwolle
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In 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 are a candidate for CR and non-voluntary to participate in the regular CR programme - Signed written informed consent - One of the following criteria: o Patients with an acute coronary syndrome, including myocardial infarction (MI) and/or revascularisation within 3 months prior to the start of the CR programme o Patients that underwent a percutaneous coronary intervention (PCI) within 3 months prior to the start of the CR programme o Patients that received coronary artery bypass grafting (CABG) within 3 months prior to the start of the CR programme 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)

Exclusion criteria

Exclusion criteria: A 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 - No access, availability or insufficient knowledge of a computer with internet - Implanted cardiac device (pacemaker, ICD)

Design outcomes

Primary

MeasureTime frame
Difference in peak oxygen uptake (VO2peak) between the end of CR programme (T1) and baseline (T0).

Secondary

MeasureTime frame
o Difference in VO2peak between 12 months (T2) and T0 o Difference in VO2peak between T2 and T1 o Traditional risk factors for CVD o Major Adverse Cardiovascular Events (MACE) o General health o Care utilisation o Costs of care utilisation o Adherence o Compliance

Contacts

Public ContactLeonie Prins

Diagram B.V.

l.prins@diagram-zwolle.nlTel: +31 (38)4262999

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)