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An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial
Cohen A, Assyag P, Boyer-Chatenet L, Cohen-Solal A, Perdrix C, Dalichampt M, Michel P-L, Montalescot G, Ravaud P, Steg PG, Boutron I, for the Reseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators
JAMA Internal Medicine 2014 Jan;174(1):40-48
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

IMPORTANCE: Lifestyle improvements after an acute coronary syndrome reduce cardiovascular risk but are difficult to achieve. OBJECTIVE: To determine whether a nurse-led or dietician-led cardiovascular risk factor education program would improve risk factor reduction over the long term after an acute coronary syndrome. DESIGN, SETTING, AND PARTICIPANTS: The RESeau Insuffisance CARDiaque (RESICARD) prevention study was a 2-arm, parallel-group, multicenter, randomized clinical trial at 6 tertiary care hospitals in France. Patients hospitalized in a cardiac intensive care unit for an acute coronary syndrome with at least 1 lifestyle risk factor (current smoking, sedentary lifestyle, or overweight or obesity) were randomized according to a computer-generated list with sequentially numbered, sealed envelopes. INTERVENTION: Patients underwent an education program in a unique non-hospital setting (a house of education) or were treated according to physicians' usual standard of care. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite that included at least 1 of the following: smoking cessation, at least 3 hours per week of physical activity, at least 5% reduction in weight, and at least 4% reduction in waist circumference. Patients were followed up for 1 year. An intent-to-treat analysis was performed. RESULTS From June 21, 2006, to July 30, 2008, a total of 251 patients were randomized to the house of education and 251 to conventional care. The 2 groups did not differ significantly at 12 months in the primary composite outcome (51.8% versus 49.8% success rate; adjusted relative risk (aRR) 1.11; 95% CI 0.90 to 1.37) or with correction of all risk factors (aRR 1.22; 95% CI 0.89 to 1.66). Similarly, the 2 groups did not differ by physical activity (aRR 1.05; 95% CI 0.92 to 1.21), smoking cessation (aRR 0.99; 95% CI 0.87 to 1.13), and weight or waist reduction (aRR 1.07; 95% CI 0.84 to 1.36). CONCLUSIONS AND RELEVANCE: Compared with conventional care, the house of education did not result in superior improvement in lifestyle-related cardiovascular risk factors after an acute coronary syndrome. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00337480.

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