OPTImal CArdiac REhabilitation (OPTICARE)Following Acute Coronary Syndromes: A Randomized, Controlled Trial to Investigate the Benefits of an Expanded Educational and Behavioural Intervention Program.

Rationale: Throughout the western world, healthy life style management is becoming increasingly important. Therefore, secondary prevention with an emphasis on lifestyle adjustments should be the cornerstone of modern cardiac rehabilitation (CR). This study may demonstrate the benefits of extended CR with respect to achieving optimal long term secondary prevention goals.

Objective: The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions (OPTICARE and COACH) and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard CR.

Study design: The proposed trial is a singlecenter, multi-disciplinary randomized controlled trial with a 18-month follow-up. In total 900 patients will be randomized into 3 arms:(1) Standard CR according to the Dutch guidelines; (2) OPTICARE intervention: standard CR and participation in multifactorial lifestyle sessions during rehabilitation and additional sessions at 4, 6 and 12 months and a personalized program to promote an active lifestyle; (3) COACH intervention: standard CR according to the Dutch guidelines followed by 5 telephone delivered coaching sessions starting at 6 weeks intervals (up to 6 months). The enrollment period will be 24 months, the intervention period is 12 months and the duration of the follow-up will be another 6 months. Assessments will take place at 4 time points: at baseline, 12 weeks after inclusion (end standard CR), at 12 and at 18 months.

Study population: Patients referred for standard CR will be included to participate in this trial. ACS patients treated with primary or elective PCI or CABG, with a stable medical condition and providing written informed consent are eligible to participate.

Intervention: OPTICARE intervention: Standard CR and obligation to participate in multifactorial lifestyle and risk factor sessions (medical information, dietary advises, risk factors and emotional advises). Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counsellor during and after completion of rehabilitation. If applicable, patients will participate in smoking cessation, dietary and stress management programs. Additional supervised multifactorial lifestyle and risk management training sessions of each 2 hours are provided at 4, 6 and 12 months. COACH intervention: standard CR according to the Dutch guidelines followed by 5 telephone based coaching sessions starting at 6 weeks intervals up to 6 months. The coaching sessions include assertiveness training, goal setting and reassessment.