Does in‐shoe pressure analysis to assess and modify medical grade footwear improve patient adherence and understanding? A mixed methods study

Abstract

Background Medical grade footwear (MGF) with demonstrated plantar-pressure reducing effect is recommended to reduce the risk of diabetes-related foot ulceration (DFU). Efficacy of MGF relies on high adherence (≥ 80%). In-shoe pressure analysis (IPA) is used to assess and modify MGF, however, there is limited evidence for the impact on patient adherence and understanding of MGF. The primary aim of this study was to determine if self-reported adherence to MGF usage in patients with previous DFU improved following IPA compared to adherence measured prior. The secondary aim was to determine if patient understanding of MGF improved following in-shoe pressure analysis. Methods Patients with previous DFU fitted with MGF in the last 12 months were recruited. The first three participants were included in a pilot study to test procedures and questionnaires. MGF was assessed and modified at Week 0 based on findings from IPA using the Pedar system (Novel). Patients completed two questionnaires, one assessing patient adherence to MGF at Week 0 and Week 4, the other assessing patient understanding of MGF before and after IPA at week 0. Patient understanding was measured using a 5-point Likert scale (strongly disagree 1 to strongly agree 5). Patient experience was assessed via a telephone questionnaire administered between Weeks 0–1. Results Fifteen participants were recruited, and all completed the study. Adherence of ≥ 80% to MGF usage inside the home was 13.3% (n = 2) pre-IPA and 20.0% (n = 3) at Week 4. Outside the home, ≥ 80% adherence to MGF was 53.3% (n = 8) pre-IPA, and 80.0% (n = 12) at Week 4. Change in scores for understanding of MGF were small, however, all participants reported that undergoing the intervention was worthwhile and beneficial. Conclusions Self-reported adherence inside the home demonstrated minimal improvement after 4 weeks, however, adherence of ≥ 80% outside the home increased by 27%, with 80% of all participants reporting high adherence at Week 4. Participants rated their learnings from the experience of IPA as beneficial.

Guidelines on the prevention of foot ulcers in persons with diabetes (IWGDF 2023 update)

“…As we noted in our previous guideline, 16 adherence to an intervention has been shown to be crucial in preventing foot ulcers, and it is consistently reported that people with diabetes who do not adhere present with higher rates of ulceration 9 . Several studies have investigated methods to improve adherence, 36,70,71 but a stronger focus on the development, evaluation and implementation of methods that improve adherence to preventative foot treatment remains urgently needed. In turn, evaluating and optimising feasibility and acceptability of treatments for people with diabetes, should be a key priority in the ongoing development and clinical research on the prevention of diabetes‐related foot ulceration. Probably the three most common preventative actions in daily clinical foot practice globally are foot screening (recommendations 1 and 2), foot self‐care (recommendations 3 and 4), and (structured) education (recommendation 5).…”

“…As we noted in our previous guideline, 16 adherence to an intervention has been shown to be crucial in preventing foot ulcers, and it is consistently reported that people with diabetes who do not adhere present with higher rates of ulceration. 9 Several studies have investigated methods to improve adherence, 36,70,71 More research in this area is needed.…”