Background: Cardiovascular diseases are among the most common causes of death in industrialized countries. The goal of the DECADE study ("decision aid, action planning, and follow-up support for patients to reduce the 10-year risk of cardiovascular diseases") is to improve patient activation and health-related behavior by means of structured cardiovascular risk counseling and DECADE brochures. In this pilot study, the applicability of DECADE and the potential effects of the intervention on patients with cardiovascular risk factors were investigated.
Methods: 87 patients were included in the two-arm, randomized, controlled pilot study. All of them participated in four structured counseling sessions. The A+D group received DECADE brochures (intervention group), while the A group did not (control group). The change in patient activation four months later (PAM13-D) was the primary endpoint. Secondary endpoints included, among others, changes in health status and health-related behavior, goal achievement, and patient satisfaction. These changes were studied in an intention-to-treat analysis.
Results: Endpoint data were available for 78 patients (38 in the A+D group and 40 in the A group) at four months. The use of DECADE brochures had a significant beneficial effect on PAM13-D scores (an increase of 3.30 points, p = 0.023), corresponding to a moderate effect size of 0.54. Positive trends were seen in most of the other endpoints. The improved patient activation was associated with an overall reduction of risk factors.
Conclusion: This pilot study shows that DECADE can support patient activation. The effects can be expected to be stronger in a larger study and in comparison to usual care. If this can be confirmed, DECADE should be embedded in routine patient care.