Department of Psychology, Health and Technology, Centre for eHealth Research and Wellbeing, TechMed Centre, University of Twente, PO Box 217, 7500 AE,, Enschede, The Netherlands.
Department of Rehabilitation, Amsterdam UMC, location Academic Medical Centre, University of Amsterdam, Amsterdam Movement Sciences, Meibergdreef 9, 1105 AZ,, Amsterdam, The Netherlands.
Trials. 2021 Oct 28;22(1):750. doi: 10.1186/s13063-021-05680-0.
Diabetic foot ulcers have a high impact on mobility and daily functioning and lead to high treatment costs, for example, by hospitalization and amputation. To prevent (re)ulcerations, custom-made orthopedic shoes are considered essential. However, adherence to wearing the orthopedic shoes is low, and improving adherence was not successful in the past. We propose a novel care approach that combines motivational interviewing (MI) with a digital shoe-fitting procedure to improve adherence to orthopedic shoes. The aim of this trial is to assess the (cost-)effectiveness of this novel care approach compared to usual care (no MI and casting-based shoe-fitting) in promoting footwear adherence and ulcer prevention.
The trial will include people with diabetes, with IWGDF Risk categories 1-3, who have been prescribed orthopedic shoes. Participants will be randomized at the level of the podiatrist to the novel care approach or usual care. The primary outcome is the proportion of participants who adhere to the use of their orthopedic shoes, that is, who take at least 80% of their total daily steps with orthopedic shoes. A temperature microsensor will be built into the participants' orthopedic shoes to measure wearing time continuously over 12 months. In addition, daily activity will be measured periodically using log data with an activity monitor. Data from the temperature microsensor and activity monitor will be combined to calculate adherence. (Re-)experienced complications after receiving orthopedic shoes will be registered. Questionnaires and interviews will measure the experiences of participants regarding orthopedic shoes, experiences of podiatrists regarding motivational interviewing, care consumption, and quality of life. Differences in costs and quality of life will be determined in a cost-effectiveness analysis.
This trial will generate novel insights into the socio-economic and well-being impact and the clinical effectiveness of the novel care approach on adherence to wearing orthopedic shoes.
Netherlands Trial Register NL7710 . Registered on 6 May 2019.
糖尿病足溃疡对活动能力和日常功能有很大影响，并导致治疗费用高昂，例如住院和截肢。为了预防（再）溃疡，定制矫形鞋被认为是必不可少的。然而，人们对矫形鞋的依从性较低，过去提高依从性的努力并未成功。我们提出了一种新的护理方法，将动机访谈（MI）与数字鞋适配程序相结合，以提高对矫形鞋的依从性。本试验旨在评估与常规护理（无 MI 和基于铸造的鞋适配）相比，这种新的护理方法在促进鞋具依从性和预防溃疡方面的（成本）效果。
该试验将包括患有糖尿病且 IWGDF 风险类别为 1-3 的患者，他们已被开具矫形鞋处方。参与者将在足病医生的层面上随机分配到新的护理方法或常规护理组。主要结局是参与者坚持使用矫形鞋的比例，即每天至少 80%的时间穿着矫形鞋。将在参与者的矫形鞋中内置一个温度微传感器，以连续 12 个月测量佩戴时间。此外，将使用活动监测器的日志数据定期测量日常活动。将温度微传感器和活动监测器的数据相结合，计算出依从性。（再）经历接受矫形鞋后的并发症将被记录。将使用问卷和访谈来测量参与者对矫形鞋的体验、足病医生对动机访谈的体验、护理消耗和生活质量。将在成本效益分析中确定成本和生活质量的差异。
该试验将为新的护理方法对穿戴矫形鞋的依从性的社会经济和幸福感影响以及临床效果提供新的见解。
荷兰试验注册 NL7710。注册于 2019 年 5 月 6 日。
