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

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dc.contributor.author Lazo-Porras, Maria
dc.contributor.author Bernabe-Ortiz, Antonio
dc.contributor.author Sacksteder, Katherine A.
dc.contributor.author Gilman, Robert H.
dc.contributor.author Malaga, German
dc.contributor.author Armstrong, David G.
dc.contributor.author Miranda, J. Jaime
dc.date.accessioned 2019-02-06T14:51:21Z
dc.date.available 2019-02-06T14:51:21Z
dc.date.issued 2016
dc.identifier.uri http://doi.org/10.1186/s13063-016-1333-1
dc.identifier.uri http://repositorio.upch.edu.pe/handle/upch/5224
dc.description.abstract 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). TempStat 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. TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .
dc.language.iso eng
dc.publisher BMC
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Self Care
dc.subject Telemedicine/instrumentation
dc.subject Thermometry/instrumentation
dc.subject Adolescent
dc.subject Adult
dc.subject Aged
dc.subject Aged, 80 and over
dc.subject Body Temperature
dc.subject Cell Phone
dc.subject Clinical Protocols
dc.subject Diabetes mellitus
dc.subject Diabetes Mellitus, Type 2/diagnosis/epidemiology/therapy
dc.subject Diabetic Foot/diagnosis/epidemiology/physiopathology/prevention & control
dc.subject Diabetic neuropathies
dc.subject Equipment Design
dc.subject Female
dc.subject Health Knowledge, Attitudes, Practice
dc.subject Humans
dc.subject Incidence
dc.subject Male
dc.subject mHealth
dc.subject Middle Aged
dc.subject Patient Education as Topic
dc.subject Peru/epidemiology
dc.subject Predictive Value of Tests
dc.subject Reminder Systems
dc.subject Research Design
dc.subject Risk Factors
dc.subject Text Messaging
dc.subject Thermometry
dc.subject Time Factors
dc.subject Treatment Outcome
dc.subject Type 2 ulcer
dc.subject Young Adult
dc.title Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial
dc.type info:eu-repo/semantics/article
dc.identifier.journal Trials


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