The effectiveness of motivational interviewing on adherence to wearing orthopedic shoes in people with diabetes at low-to-high risk of foot ulceration: A multicenter cluster-randomized controlled trial

Aim: To evaluate the effectiveness of motivational interviewing (MI) performed by MI-trained podiatrists in improving adherence to wearing orthopedic shoes in comparison to usual care in people with diabetes at low-to-high risk of ulceration. Methods: People with diabetes with loss of protective sensation and/or peripheral artery disease, and with orthopedic shoes prescription were allocated to receive one MI-consultation by a podiatrist randomized to MI training (n = 53) or usual care only (n = 68). Adherence was measured as the percentage of steps taken while wearing orthopedic shoes, determined using an insole temperature microsensor and wrist-worn activity tracker during one week at 3 and 6 months. Results: The proportion of participants ≥80 % adherent to wearing their orthopedic shoes was higher in the control group than in the MI-intervention group at 3 months (30.9 % versus 15.1 %; p = 0.044), and not significantly different at 6 months (22.1 % versus 13.2 %; p = 0.210). Average adherence was also higher in the control group than the intervention group at both 3 months (60.9 % versus 50.9 %; p = 0.029) and 6 months (59.9 % versus 49.5 %; p = 0.025). Conclusions: One podiatrist-led MI-consultation in its current form did not result in higher adherence to wearing orthopedic shoes in people with diabetes 3 and 6 months after inclusion. Trial registration: Netherlands Trial Register NL7710 (available on the International Clinical Trials Registry Platform).