Randomized clinical trial for an extended cardiac rehabilitation program using telemonitoring

Randomized clinical trial for an extended cardiac rehabilitation program using telemonitoring - TeleCaRe study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41024

Enrollment

120

Registered

2014-06-02

Start date

2014-09-10

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

cardiovascular disease heart disease

Interventions

The intervention of the study starts when patients finish their initial cardiac rehabilitation program. Patients participating in the extended cardiac rehabilitation program with telemonitoring will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients participating in cardiac rehabilitation (minimal attendance of 80% in physical program) - Signed written informed consent - One of the following criteria: o Patients with an acute coronary syndrome, including myocardial infarction (MI) within 3 months prior to start cardiac rehabilitation program o Patients that underwent a percutaneous coronary intervention (PCI) within 3 months prior to prior to start cardiac rehabilitation program o Patients that received coronary artery bypass grafting (CABG) within 3 months prior to start cardiac rehabilitation program

Exclusion criteria

Exclusion criteria: - Contraindication to cardiac rehabilitation - Mental impairment leading to inability to cooperate - Severe impaired ability to exercise - Signs of cardiac ischemia and/or a positive exercise testing on cardiac ischemia - Insufficient knowledge of the Dutch language - No access, availability or insufficient knowledge of a computer with internet - Implanted cardiac device (pacemaker, ICD)

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint is physical fitness defined by peak oxygen uptake obtained from an incremental maximal cycle ergometer exercise test at 12 months.	—

Secondary

Measure	Time frame
o Physical fitness (peak oxygen uptake obtained from maximal incremental cycle ergometer exercise test) at baseline and 6 months. o Cardiac structure and function (cardiac dimensions, systolic and diastolic function parameters, valve disorders) at baseline and 12 months. o General health (quality of life (KVL-H), physical functioning (IPAQ-long version), emotional functioning (PHQ-9, HADS), social functioning (MPSS) at baseline, 6 months and 12 months. o Traditional risk factors (i.e. cholesterol, lipid profile, HbA1C, blood pressure, and body characteristics) at baseline, 6 months and 12 months. o Compliance (use of the smartphone in the intervention group for at least half an hour at 5 five days per week during the first 6 months of the study) o Care consumption ((days) admission, outpatient clinic visits, GP visits, interventions, radiology, nuclear and lab testing) collected throughout the study period. o Major Adverse Cardiovascular Events (cardiovascular (CV) mortality, all-cause mortality, near sudden cardiac death, acute coronary syndrome, CV intervention/surgery, CV hospital admission, CV Emergency visits) collected throughout the study period.	—

Measure

Time frame

o Physical fitness (peak oxygen uptake obtained from maximal incremental cycle ergometer exercise test) at baseline and 6 months. o Cardiac structure and function (cardiac dimensions, systolic and diastolic function parameters, valve disorders) at baseline and 12 months. o General health (quality of life (KVL-H), physical functioning (IPAQ-long version), emotional functioning (PHQ-9, HADS), social functioning (MPSS) at baseline, 6 months and 12 months. o Traditional risk factors (i.e. cholesterol, lipid profile, HbA1C, blood pressure, and body characteristics) at baseline, 6 months and 12 months. o Compliance (use of the smartphone in the intervention group for at least half an hour at 5 five days per week during the first 6 months of the study) o Care consumption ((days) admission, outpatient clinic visits, GP visits, interventions, radiology, nuclear and lab testing) collected throughout the study period. o Major Adverse Cardiovascular Events (cardiovascular (CV) mortality, all-cause mortality, near sudden cardiac death, acute coronary syndrome, CV intervention/surgery, CV hospital admission, CV Emergency visits) collected throughout the study period.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)