A randomised controlled trail in diabetes demonstrating the positive impact of a patient activation strategy on diabetes processes and HbA1c: The WICKED project.

Background: Patient activation is a demonstration of people participating effectively in their own care as measurable in objective outcomes. Techniques of activating patients are various. Aims: We developed a structured information booklet to promote patient activation and report the 1-year outcomes of a randomised controlled trial assessing its impact on diabetes care processes and on glycaemic control. Design and setting: It is an open label cluster randomised trial involving all people with diabetes aged more than 18 years within Wolverhampton Clinical Commissioning Group. Methods: All people with diabetes were cluster randomised into a group who were multiply mailed (MM) at 0, 3 and 6 months whilst a control group was mailed once at 3 months. Comparison of a Failed Process Score (FPS) between active and control groups was performed at 0, 3 and 12 months and of HbA1c at baseline and 12 months. Results: FPS improved significantly with multiple mailing (p=0.013), with particular impact on those with poor baseline FPS (≥2) (achieved FPS ≤1 at 12 months 49.2% vs. 46.0%, χ2=6.09, p<0.05). Overall HbA1c% across the year (adjusted) was significantly better with MM (p=0.021), with specific impact in those with a baseline HbA1c ≤7.5 (MM HbA1c% 6.7±0.07 (mean±SEM) vs. 7.0±0.09; mean±SEM difference 0.3±0.1, F=11.1, p=0.009). Conclusion: The direct provision of structured information to people with diabetes activates them to engage in their care delivery as reflected in care process and glycaemic control outcomes.