TY - JOUR
T1 - Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration
T2 - a 12 months observational study
AU - Exterkate, Stein H.
AU - Jongebloed-Westra, Manon
AU - ten Klooster, Peter M.
AU - Koffijberg, Hendrik
AU - Bode, Christina
AU - van Gemert-Pijnen, Julia E. W. C.
AU - van Baal, Josephus G.
AU - van Netten, Jaap J.
N1 - Funding Information: This trial was funded by ZonMw (the Netherlands Organisation for health Research and Development, project no. 853001101). Both the funder and sponsor (University of Twente) had no influence in the study design; the collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication and had no ultimate authority over any of these activities. Funding Information: We would like to thank all podiatrists and pedorthists of Voetencentrum Wender and Voetmax Orthopedie who contributed during the inclusion and follow-up of participants. Publisher Copyright: © 2023, The College of Podiatry and the Australasian Podiatry Council.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants’ demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. Methods: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants’ wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. Results: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), “satisfaction with my wear of orthopaedic footwear” was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. Conclusions: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people’s wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. Trial registration: Netherlands Trial Register NL7710. Registered: 6 May 2019.
AB - Background: Orthopaedic footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Robust data on long-term wearing time of orthopaedic footwear are not available, and needed to gain more insights into wearing patterns and associated factors (i.e. participants’ demographic, disease-related characteristics, and footwear usability). We aimed to objectively assess long-term wearing patterns and identify factors associated with wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of ulceration. Methods: People diagnosed with diabetes mellitus type 1 and 2 with loss of protective sensation and/or peripheral artery disease and prescribed with orthopaedic footwear were included and followed for 12 months. The primary outcome was mean daily wearing time, continuously measured using a temperature sensor inside the footwear (Orthotimer®). Adherence to wearing orthopaedic footwear was calculated as percentage of wearing time of a total assumed 16 h out-of-bed daytime, where adherence < 60% was a pre-determined non-adherent threshold. Wearing time patterns were assessed by calculating participants’ wearing (in)consistency. One-way analyses of variance tested for wearing time differences between subgroups, weekdays, and weekend days. Factors potentially associated with wearing time were collected by questionnaires and medical files. Univariately associated factors were included in multivariate linear regression analysis. Results: Sixty one participants were included (mean (SD) age: 68.0 (7.4) years; females: n = 17; type 2 diabetes mellitus: n = 54). Mean (SD) overall daily wearing time was 8.3 (6.1) hours/day. A total of 40 (66%) participants were non-adherent. Participants with a consistent wearing pattern showed higher daily wearing times than participants with an inconsistent pattern. Mean (SD) wearing times were 12.7 (4.3) vs 3.6 (4.8) hours/day, respectively (P < 0.001). Mean (SD) wearing time was significantly higher (P < 0.010) during weekdays (8.7 (6.0) hours/day) compared to Saturday (8.0 (6.1) hours/day) and Sunday (6.9 (6.2) hours/day). In the multivariate model (R2 = 0.28), “satisfaction with my wear of orthopaedic footwear” was positively associated (P < 0.001) with wearing time. The other seven multivariate model factors (four demographic variables and three footwear usability variables) were not associated with wearing time. Conclusions: Only one out of three people at moderate to high risk of foot ulceration were sufficiently adherent to wearing their orthopaedic footwear. Changing people’s wearing behaviour to a more stable pattern seems a potential avenue to improve long-term adherence to wearing orthopaedic footwear. Investigated factors are not associated with daily wearing time. Based on these factors the daily wearing time cannot be estimated in daily practice. Trial registration: Netherlands Trial Register NL7710. Registered: 6 May 2019.
KW - Diabetes mellitus
KW - Diabetic foot
KW - Orthopaedic footwear
KW - Treatment adherence and compliance
KW - Wearing time
UR - http://www.scopus.com/inward/record.url?scp=85171143144&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13047-023-00656-6
DO - https://doi.org/10.1186/s13047-023-00656-6
M3 - Article
C2 - 37705016
SN - 1757-1146
VL - 16
JO - Journal of Foot and Ankle Research
JF - Journal of Foot and Ankle Research
IS - 1
M1 - 60
ER -