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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.
To assess the validity and feasibility of a new temperature-based adherence monitor to measure footwear use.
University medical center and participants' homes.
A convenience sample of 11 healthy subjects and 14 neuropathic diabetic patients at high risk for foot ulceration.
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.
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.
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.
Re: Monitoring therapeutic footwear use compliance
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.