Community-based comprehensive lifestyle programs in patients with coronary artery disease: Objectives, design and expected results of Randomized Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists 2 trial (RESPONSE 2)

Patients with coronary artery disease (CAD) are at high risk of recurrent events. A healthy lifestyle can significantly reduce this risk. A previous trial, Randomized Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists (RESPONSE), demonstrated that nurse-coordinated outpatient clinics improve drug treatment of cardiovascular risk factors. However, lifestyle-related risk factors, including smoking, overweight, and physical inactivity, were common and remained largely unchanged at follow-up in most patients (66%). The aim of the current study is to evaluate the impact of 3 community-based lifestyle programs in patients after hospitalization for CAD. We are conducting a multicenter (n = 15), randomized trial that will recruit 800 patients to test the efficacy of up to 3 widely available commercial lifestyle programs, aimed at patients and their partners, on top of usual care. These programs are aimed at smoking cessation (Luchtsignaal®), weight loss (Weight Watchers®), and improving physical activity (Philips DirectLife®).OutcomesThe primary outcome at 12 months is the proportion of patients in whom at least 1 lifestyle risk factor is improved without deterioration in any of the other 2, and a relative increase of at least 30% in this proportion is considered clinically relevant.