Effectiveness of Cardiovascular Prevention Programs in Primary Care (PreCardio): a randomized clinical trial.

Abstract

Effectiveness of Cardiovascular Prevention Programs in Primary Care (PreCardio): a randomised clinical trial Neree Claes, Nele Jacobs, Els Clays, Ward Schrooten

Purpose Cardiovascular is a major cause of mortality and morbidity and its prevalence is set to increase. While the benefits of medical and lifestyle interventions is established, the effectiveness of interventions which seek to improve the way preventive care is delivered in primary care is less so. The purpose was to study the effectiveness of 2 intervention programs in reducing cardiovascular risk factors within primary care. Methods A randomized controlled trial conducted in Belgium 2007-2010 with 295 participants allocated to a medical (=MP) and a medical + behavioral (=MBP) program. Results The median age was 40 years (IQR 32– 49), There were no significant differences in baseline characteristics between MP and MBP. Our drop-out after three years of intervention was 13%. there was a significant decrease in total cholesterol (median difference: -4,5 mg/dl; p<0,001), systolic blood pressure (-1 mmHg; p=0,016), and diastolic blood pressure (-16,5 mmHg; p<0,001). There was a significant increase in BMI (+0,3 kg/m²; p<0,001). There were no significant differences found between MP and MBP in primary outcomes. At baseline, 48 participants were smoker compared to 29 at the study endpoint. Overall there was a significant decrease in fitness-score (median difference: -2; p=0,035). Calculation of the total cardiovascular risk for participants gave a median score of 0,35 (IQR 0,11 – 1,19) at baseline and 0,34 (IQR 0,091 – 1,11) at end-point (p<0,001). During the study period one participant in the MBP had a cardiovascular event. Conclusion Both intervention programs are effective in reducing cardiovascular risk factors. In our population the combined medical and behavioural program was not superior to the medical program.