Adherence to ortopaedic shoes

Background of the study:
Diabetic foot ulcers are a leading cause of hospitalization, amputation and high treatment costs. Personalized orthopaedic shoes are considered essential to prevent (re)ulcerations, and adherence to this footwear is crucial. However, adherence to orthopaedic footwear is often low and there is a lack of insight in methods to improve this adherence. We propose a novel care approach, motivational interviewing (MI) and a digital shoe-fitting procedure, to improve adherence to custom-made footwear and to be (cost-) effective. The aim of this trial is to assess the (cost-)effectiveness of this novel care procedure (MI combined with digital fitting) compared to the usual care (no MI and traditional casting-based fitting) in terms of footwear adherence and ulcer prevention.

Objectives of the study:
Primary objective: To compare the proportion of patients who are sufficiently adherent to the use of their orthopaedic shoes, that is, take at least 80% of their total steps with custom-made footwear between the patients receiving the novel care procedure and the usual care.
Secondary objectives: To compare the level of adherence to the use of orthopaedic shoes of patients between novel and usual care and the proportion of patients (re-) experiencing complications up to one year after receiving their shoes. To compare patients’ knowledge about the aim of custom-made footwear, satisfaction with information given by podiatrists, patients’ behavioural intentions and satisfaction with footwear. To assess the MI-trained podiatrists’ knowledge about MI, experiences and attitudes towards applying MI in this group of patients. To assess the difference in costs and patient-perceived quality of life, between patients receiving novel care and usual care and the cost-effectiveness of the new digital scanning procedure with motivational interviewing compared with the traditional procedure.

Study design:
A randomized controlled trial with (cost-)effectiveness analysis and qualitative and quantitative process analyses.

Study population:
220 patients with diabetes mellitus, who are identified with risk profiles 2, 3 or 4, and with and without previous ulcers or callus, will be included. These patients have also a prescription for orthopaedic shoes.

Currently there is little knowledge about the effectiveness of (biopsychosocial) interventions and the cost-effectiveness of adherence to orthopaedic shoes has not been studied at all. Therefore the aim of the current study is to assess the (cost-)effectiveness of a novel care procedure (MI combined with digital fitting) compared to the usual care (no MI and traditional casting-based fitting) in footwear adherence and ulcer prevention. This study will generate insights into the socio-economic impact of the novel care procedure on adherence to orthopaedic shoes. These are crucial steps towards better ulcer prevention in people with diabetes at high-risk.

-T2: Initial eligibility screen, study information to participant, initial willingness to participate and crosscheck inclusion/exclusion criteria
-T1: Informed consent, final eligibility screen, allocation and in depth interview
T0: Receiving first pair of orthopaedic shoes, demographic and disease-related characterstics, physical characteristics, RAND-36 V2.0, EQ-5D-5L, iMCQ
T1: Data transfer of shoe-sensors, activity registration
T2: Data transfer of shoe-sensors, activity registration, RAND-36 V2.0, EQ-5D-5L, and in depth interview or MOS2
T3: Data transfer of shoe-sensors
T4: Data transfer of shoe-sensors, RAND-36 V2.0, EQ-5D-5L, iMCQ and MOS2

The timepoint will as far as possible combined with consultation of usual care.

One group will receive motivational interviewing combined digital fitting of orthopaedic shoes and the other group will receive no motivational interviewing combined with traditional fitting of orthopaedic shoes.