Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial

Background: Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. Methods/design: This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. Interventions: participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat (TM)). TempStat (TM) is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm will receive an mHealth component in the form of SMS and voice messages as reminders to use the thermometry device, and instructions to promote foot care. Outcomes: the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study. Discussion: This study has two principal contributions towards the prevention of DFU. First, the introduction of messages to promote self-management of diabetes foot care as well as using reminders as a strategy to improve adherence to daily home-based measurements. Secondly, the implementation of a thermometry-based strategy complemented by SMS and voice messages in an LMIC setting, with wider implications for scalability.This project is funded by the Fogarty International Center, National Institutes of Health (R21TW009982), under the GACD Program. The establishment of the CRONICAS Centre of Excellence in Chronic Diseases at Universidad Peruana Cayetano Heredia was funded in whole with Federal funds from the National Heart, Lung and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract Number HHSN268200900033C.; AB-O is a research training fellow in public health and tropical medicine funded by the Wellcome Trust (103994/Z/14/Z). JJM currently receives, or has received during the planning of this study, further support from the Alliance for Health Policy and Systems Research (HQHSR1206660), Consejo Nacional de Ciencia y Tecnologia (CONCYTEC), Grand Challenges Canada (0335-04), the International Development Research Center Canada (106887-001), the Inter-American Institute for Global Change Research (IAI CRN3036), the National Heart, Lung and Blood Institute (5U01HL114180, HHSN268200900028C-3-0-1), the National Institute of Mental Health (1U19MH098780), the Swiss National Science Foundation (40P740-160366), Universidad Peruana Cayetano Heredia, and the Wellcome Trust (GR074833MA, WT093541AIA).This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at repository@u.library.arizona.edu