Rehabilitation After Acute Coronary Syndrome: a New Telemonitoring Strategy
Condition: Angina, Unstable; Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); ST-segment Elevation Myocardial Infarction (STEMI)
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Angina, Unstable; Infarction
Study type: Interventional

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.
    

Intervention name(s): telemonitoring; Centre-based cardiac rehabilitation
Intervention type(s): Device; Other
Intervention description(s): The system consists of the following elements:
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.
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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase III clinical trial, feasibility, controlled and randomized, with two arms: cardiac telerehabilitation (intervention group) and centre-based cardiac rehabilitation (control group)
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: mobile health; monitoring; cardiac rehabilitation; telerehabilitation; secondary prevention