An Integrated Personalized Multimodal Intervention Improves Adherence to Wearing Custom-Made Footwear in People With Diabetes at High Foot Ulcer Risk: A Multicenter Randomized Controlled Trial (DIASSIST).

Abstract

Diabetes-related foot ulcers impose a large burden on patients and society. To prevent foot ulcers, adherence to wearing custom-made footwear is essential. However, adherence is often low in people at high ulcer risk, while evidence for interventions that improve adherence is scarce. We assessed the effectiveness of an integrated personalized multimodal intervention on footwear adherence in people with diabetes at high risk of ulceration. In a multicenter randomized controlled trial, 126 participants with diabetes, peripheral neuropathy, ulcer history, and custom-made footwear were randomized to usual care or enhanced treatment. Usual care was guideline-based; that is, custom-made footwear, nonstructured education, and podiatric foot care and screening. Enhanced treatment consisted of usual care plus pressure-optimized custom-made footwear, provision of indoor-specific custom-made footwear, structured education, and motivational interviewing that included personalized feedback. The primary outcome was footwear adherence (i.e., percentage of steps taken wearing prescribed footwear) objectively measured at 6 and 12 months of follow-up. A secondary outcome was shoe-wearing time in hours per day, assessed 2 weeks before and after study visits. Footwear adherence was significantly higher for enhanced treatment compared with usual care: 75% (SD 10) vs 56% (SD 22) at 6 months (i.e., relative increase 34%, P < 0.001), and 58% (SD 18) vs 49% (SD 20) at 12 months (P = 0.013). Shoe-wearing time significantly increased after the randomization visit in which structured education was provided (7.8-8.3 h/day, P = 0.049) and after the provision of indoor-specific footwear (7.7-9.4 h/day, P < 0.001). Footwear adherence can be significantly increased through an integrated personalized multimodal intervention.