NCT04942977

Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

Prevention and Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Catcronic Salut SL · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

Cardiac rehabilitation after an acute coronary syndrome is recognised in the latest guidelines and recommendations published by the major scientific societies as a class I indication. Despite this evidence, the number of patients entering such programmes in Europe is still around 30%. The present study aims to validate a new comprehensive Telerehabilitation System to provide support for cardiac rehabilitation, to optimize it and to test its usefulness in terms of improving adherence to physical exercise and cardiovascular risk parameters.

Detailed description

To validate this approach, a clinical trial was designed to compare a 10-month program of cardiac telerehabilitation with a conventional 8-week centre-based cardiac rehabilitation. Seventy patients will be randomized 1:1 to cardiac telemonitoring or centre-based cardiac rehabilitation. The characteristics of the interventions do not allow the study to be blinded to the patient or the professional. However, the analyses, stress tests and questionaires will be carried out in a masked form without the assigned group being identified by the researchers carrying out the examinations. Assessment for primary and main secondary outcomes will be performed at baseline and at ten months of follow-up, and will include self-reported physical activity (IPAQ), VO2max, blood test, general emotional distress, Adherence to the Mediterranean Diet, quality of life, vital signs, returning to work. The hypothesis is that patients randomised to prolonged telemonitoring will demonstrate higher levels of physical activity at 10-month follow-up, compared to patients in the centre-based cardiac rehabilitation programme, as well other positive changes in the cardiovascular risk profile.

Conditions

• Angina, Unstable
• Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
• ST-segment Elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
DEVICE	telemonitoring	The system consists of the following elements: 1. Professional website at the hospital, which allows: * To set up an individualised care plan * To establish the patient's risk profile and targets for improvement. * Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred * Advise the patient on self-management strategies. 2. Mobile application software with the following functions: * Scheduled exercise sessions * Medication reminder * Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.) * Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference. * Training monitor: guides the patient in the performance of their exercise. * Access to certified health information for patients
OTHER	Centre-based cardiac rehabilitation	The physical activity consisted of a workout routine and aerobic cycling training. Patients are instructed to perform 150 minutes per week of moderate physical activity when the hospital phase finishes.

Timeline

• Start date: 2019-05-28
• Primary completion: 2020-12-07
• Completion: 2020-12-07
• First posted: 2021-06-29
• Last updated: 2021-06-29

Locations

2 sites across 1 country: Spain