Monitoring therapeutic footwear use compliance

NewsBot · Jul 10, 2012

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New monitoring technology to objectively assess adherence to prescribed footwear and assistive devices during ambulatory activity.
Bus SA, Waaijman R, Nollet F.
Arch Phys Med Rehabil. 2012 Jul 4.

OBJECTIVE:
To assess the validity and feasibility of a new temperature-based adherence monitor to measure footwear use.

DESIGN:
Observational study.

SETTING:
University medical center and participants' homes.

PARTICIPANTS:
A convenience sample of 11 healthy subjects and 14 neuropathic diabetic patients at high risk for foot ulceration.

INTERVENTIONS:
In healthy subjects, the validity of the in-shoe attached adherence monitor was investigated by comparing its registrations of donning and doffing of footwear during 7 days to an accurately kept log registration. In diabetic patients, the feasibility of using the adherence monitor for seven days in conjunction with a time-synchronized ankle-worn step activity monitor to register prescribed footwear use during walking was assessed. Furthermore, a usability questionnaire was completed.

MAIN OUTCOME MEASURE(S):
For validity, the mean time difference and 95% CI between moments of donning/doffing footwear recorded with the adherence monitor and in the log were calculated. For feasibility, technical performance, usability, and the percentage of steps that the footwear was worn (adherence) were assessed.

RESULTS:
The mean time difference between the adherence monitor and log recordings was 0.4 minutes, 95% CI: 0.2 to 0.6 minutes. One erroneous and two incomplete recordings were obtained in diabetic patients. Three patients reported discomfort with the step activity monitor, and four patients would not favor repeated testing. Patients used their footwear for between 9% and 99% of their walking steps.

CONCLUSIONS:
The adherence monitor shows good validity in measuring when footwear is used or not, and is, together with instrumented monitoring of walking activity, a feasible and objective method to assess treatment adherence. This method can have wide application in clinical practice and research regarding prescribed footwear and other body-worn assistive devices.
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Admin2 · Jul 11, 2012

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NewsBot · Jan 17, 2013

Adherence to Wearing Prescription Custom-Made Footwear in Patients With Diabetes at High Risk for Plantar Foot Ulceration.
Waaijman R, Keukenkamp R, de Haart M, Polomski WP, Nollet F, Bus SA.
Diabetes Care. 2013 Jan 15.

OBJECTIVEPrescription custom-made footwear can only be effective in preventing diabetic foot ulcers if worn by the patient. Particularly, the high prevalence of recurrent foot ulcers focuses the attention on adherence, for which objective data are nonexisting. We objectively assessed adherence in patients with high risk of ulcer recurrence and evaluated what determines adherence.

RESEARCH DESIGN AND METHODSIn 107 patients with diabetes, neuropathy, a recently healed plantar foot ulcer, and custom-made footwear, footwear use was measured during 7 consecutive days using a shoe-worn, temperature-based monitor. Daily step count was measured simultaneously using an ankle-worn activity monitor. Patients logged time away from home. Adherence was calculated as the percentage of steps that prescription footwear was worn. Determinants of adherence were evaluated in multivariate linear regression analysis.

RESULTSMean ± SD adherence was 71 ± 25%. Adherence at home was 61 ± 32%, over 3,959 ± 2,594 steps, and away from home 87 ± 26%, over 2,604 ± 2,507 steps. In 35 patients with low adherence (<60%), adherence at home was 28 ± 24%. Lower BMI, more severe foot deformity, and more appealing footwear were significantly associated with higher adherence.

CONCLUSIONSThe results show that adherence to wearing custom-made footwear is insufficient, particularly at home, where patients exhibit their largest walking activity. This low adherence is a major threat for reulceration. These objective findings provide directions for improvement in adherence, which could include prescribing specific off-loading footwear for indoors, and they set a reference for future comparative research on footwear adherence in diabetes.
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NewsBot · Dec 20, 2018

Adherence to Therapeutic Footwear in Type 2 Diabetes in Malta.
Formosa C et al
Exp Clin Endocrinol Diabetes. 2018 Dec 17. doi: 10.1055/a-0808-4111

BACKGROUND:
The literature reports that people living with diabetes do not adhere to their prescribed therapeutic footwear as instructed. The reason for this is still uncertian although certain footwear characteristics seem to reasons reported leading to reduced level of adherence.

OBJECTIVES:
To explore the reasons for current adherence or otherwise to prescribed stock footwear amongst patients living with type-2 diabetes.

METHODS:
An exploratory qualitative design method using an Interpretative Phenomenological Analysis [IPA] was employed in this research. Employing purposive sampling, twelve participants were recruited and interviewed. Interviews were recorded, transcribed and later analysed.

RESULTS:
Common themes that emerged from this study fell under 2 main categories including 'Adherence' and 'Non - Adherence' to wearing the prescribed stock footwear. A number of themes were identified with regards to the reasons for such adherence or otherwise by respective participants including footwear characteristics, service provision, peer pressure and the patient's knowledge and attitudes.

CONCLUSION:
This study demonstrated suboptimal adherence to wearing therapeutic footwear among people with type 2 diabetes. Although the literature highlights the importance of adherence to therapeutic footwear in high risk populations for the prevention of diabetic foot complications, this study provides the reasons as to why patients still do not comply in wearing their prescribed therapeutic footwear. In order to improve behavioral changes patients would require on-going care, empowerment and support combined with educational programs to achieve a higher level of adherence. More research is warranted to explore further psychosocial interventions in diabetes care.
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NewsBot · Jul 14, 2020

Predictors of adherence to wearing therapeutic footwear among people with diabetes
Gustav Jarl, Roy Tranberg, Ulf Johansson, John Alnemo & Lars-Olov Lundqvist
Journal of Foot and Ankle Research volume 13, Article number: 45 (2020)

Aims
People at increased risk of developing diabetic foot ulcers often wear therapeutic footwear less frequently than is desirable. The aims were to identify patient groups prone to nonadherence to wearing therapeutic footwear and modifiable factors associated with adherence.

Materials and methods
A questionnaire was mailed to 1230 people with diabetes who had been fitted with therapeutic footwear. Independent variables were categorized into five domains. For each domain, variables that were associated with adherence in a univariate regression analysis were entered into a multiple regression analysis.

Results
A total of 429 (34.9%) questionnaires were analyzed. Multiple regression analyses showed significant associations (p < 0.05) between higher adherence and paid employment, current foot ulcer, previous foot ulcer, satisfaction with follow-up, self-efficacy, understanding of lost/reduced sensation as a risk factor for foot ulcerations, visible storage of therapeutic footwear at home, storage of conventional footwear out of sight, consistent choices about which footwear type to wear, and a belief that therapeutic footwear promotes ulcer healing. The five multivariate models explained 2–28% of the variance in adherence, with the strategies for footwear use domain explaining the most.

Conclusions
Patients without paid employment or without foot ulcer experience are more prone to nonadherence. To improve adherence, clinicians should advise patients to store therapeutic footwear in a visible place at home and put conventional footwear away and encourage patients’ self-efficacy and habitual use of therapeutic footwear. Future studies should investigate this topic further and explore ways to promote changes in habits. A study limitation was that all variables were self-reported.
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NewsBot · Dec 3, 2020

Adherence to
Therapeutic Diabetic
Footwear: Determinants
and Considerations

NewsBot · Jan 19, 2023

Does in-shoe pressure analysis to assess and modify medical grade footwear improve patient adherence and understanding? A mixed methods study
Clare McDonogh, Vanessa L. Nube, Georgina Frank, Stephen M. Twigg, Stefania Penkala, Samantha Holloway & Robert Snyder
Journal of Foot and Ankle Research volume 15, Article number: 94 (2022)

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.
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NewsBot · Feb 7, 2023

Adherence and Wearing Time of Prescribed Footwear among People at Risk of Diabetes-Related Foot Ulcers: Which Measure to Use?
Gustav Jarl et al
Sensors 2023, 23(3), 1648

Adherence to prescribed footwear is essential to prevent diabetes-related foot ulcers. The aim was to compare different measures of adherence and wearing time of prescribed footwear with a reference adherence measure, among people with diabetes at high risk of foot ulceration. We followed 53 participants for 7 consecutive days. A temperature sensor measured wearing time of prescribed footwear and a triaxial accelerometer assessed weight-bearing activities. Subjective wearing time was self-reported. Reference adherence measure was proportion of weight-bearing time prescribed footwear was worn. We calculated Spearman’s correlation coefficients, kappa coefficients, and areas under the curve (AUC) for the association between the reference measure and other measures of adherence and wearing time. Proportion of daily steps with prescribed footwear worn had a very strong association (r = 0.96, Κ = 0.93; AUC: 0.96–1.00), objective wearing time had a strong association (r = 0.91, Κ = 0.85, AUC: 0.89–0.99), and subjective wearing time had a weak association (r = 0.42, Κ = 0.38, AUC: 0.67–0.81) with the reference measure. Objectively measured proportion of daily steps with prescribed footwear is a valid measure of footwear adherence. Objective wearing time is reasonably valid, and may be used in clinical practice and for long-term measurements. Subjective wearing time is not recommended to be used.
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NewsBot · Sep 27, 2023

Objectively assessed long-term wearing patterns and predictors of wearing orthopaedic footwear in people with diabetes at moderate-to-high risk of foot ulceration: a 12 months observational study
Stein H. Exterkate, Manon Jongebloed-Westra, Peter M. ten Klooster, Hendrik Koffijberg, Christina Bode, Julia E. W. C. van Gemert-Pijnen, Josephus G. van Baal & Jaap J. van Netten
Journal of Foot and Ankle Research volume 16, Article number: 60 (2023)

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.
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NewsBot · Jan 12, 2024

Evaluation of usability, adherence, and clinical efficacy of therapeutic footwear in persons with diabetes at moderate to high risk of diabetic foot ulcers: A multicenter prospective study
Mateo López-Moral et al
Clin Rehabil. 2024 Jan 9

Objective: To evaluate therapeutic footwear expectations and usability of individuals with diabetes and foot complications.

Design: A prospective multicenter study was conducted on participants with a high risk of developing a diabetic foot ulcer.

Setting: Participants were enrolled in 11 different specialized diabetic foot units in Spain between March 2022 and June 2023.

Subjects: Patients with diabetes at moderate to high risk of foot ulceration receiving first therapeutic footwear prescription.

Interventions: All the patients included in the research were prescribed with their first pair of therapeutic footwear.

Main measures: Primary outcome measures were MOS-pre and MOS-post questionnaires evaluating use and usability of prescribed therapeutic footwear. Secondary outcome measures aimed to evaluate footwear clinical efficacy as ulceration rate and self-reported perceived walking distance per day.

Results: The use of therapeutic footwear exceeded the patient's pre-provision prediction of their anticipated use in 94% of people (n = 126). Based on the visual analogic satisfaction scale, the median satisfaction of daily wearing their therapeutic footwear was 7 points, Interquartile Range (IQR) [5-8.25]. During the follow-up period, 39 participants (29.1%) experienced diabetic foot ulcer. Perceived walking distance participants reported an improvement in their perceived walking ability during various daily life activities.

Conclusions: Diabetes patients at moderate to high risk of diabetic foot ulcer improved their perception of walking ability after therapeutic footwear prescription. Adherence to the therapeutic footwear prescription resulted in less ulcerations.
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