BACKGROUND: Health-conscious behavior can help prevent cardiovascular diseases. The DECADE intervention ("decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases") is designed to support primary care physicians in cardiovascular risk counseling. We studied the effects of two of its components.

METHODS: A trial with a cluster-randomized 2 x 2 design was conducted in three regions of Germany (registration number DRKS00025401). 76 primary care physicians who were randomly allocated to one of four study arms recruited a total of 797 patients with lifestyle-related cardiovascular risk factors. 712 of them were included in the analysis. Cardiovascular risk was calculated for all patients at the start of the intervention and at 12 months. The control group (CG) underwent usual treatment; intervention group (IG) 1 received DECADE patient materials; IG2 had patient-centered DECADE follow-up consultations (at week 1, at months 3, 6, and 12; and additionally at month 9, if necessary); and IG3 received both of these DECADE intervention components. The primary endpoint was the self-reported change in patient activation (Patient Activation Measure, PAM13) at month 6. The secondary endpoints were changes in health behavior and clinical parameters. Linear mixed regression models were used to analyze the effects of DECADE follow-up consultations (IG2 + IG3) versus no follow-up consultations (CG + IG1), and of DECADE materials (IG1 + IG3) versus no materials (CG + IG2), according to the 2 x 2 design.

RESULTS: DECADE follow-up consultations (compared to none) had a small positive, statistically significant effect on the primary endpoint PAM13 score of 1.14 points (95% confidence interval (CI): [0.09; 2.19], p = 0.033). The effect of DECADE patient materials (compared to none) was 0.30 (95% CI: [-0.75; 1.35], p = 0.57). Patients in all study arms showed improved health behavior.

CONCLUSION: Although the demonstrated effect on the PAM13 score is of uncertain clinical relevance, other findings of this trial imply that DECADE may effectively support physicians in cardiovascular risk counseling. A long-term trial of its clinical effects is recommended.