Universidad Peruana Cayetano Heredia

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, María de los Ángeles
dc.contributor.author Bernabé Ortiz, Antonio
dc.contributor.author Sacksteder, Katherine A.
dc.contributor.author Gilman, Robert Hugh
dc.contributor.author Málaga Rodríguez, Germán Javier
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 https://hdl.handle.net/20.500.12866/5224
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. en_US
dc.language.iso eng
dc.publisher BioMed Central
dc.relation.ispartofseries Trials
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 en_US
dc.subject Telemedicine/instrumentation en_US
dc.subject Thermometry/instrumentation en_US
dc.subject Adolescent en_US
dc.subject Adult en_US
dc.subject Aged en_US
dc.subject Aged, 80 and over en_US
dc.subject Body Temperature en_US
dc.subject Cell Phone en_US
dc.subject Clinical Protocols en_US
dc.subject Diabetes mellitus en_US
dc.subject Diabetes Mellitus, Type 2/diagnosis/epidemiology/therapy en_US
dc.subject Diabetic Foot/diagnosis/epidemiology/physiopathology/prevention & control en_US
dc.subject Diabetic neuropathies en_US
dc.subject Equipment Design en_US
dc.subject Female en_US
dc.subject Health Knowledge, Attitudes, Practice en_US
dc.subject Humans en_US
dc.subject Incidence en_US
dc.subject Male en_US
dc.subject mHealth en_US
dc.subject Middle Aged en_US
dc.subject Patient Education as Topic en_US
dc.subject Peru/epidemiology en_US
dc.subject Predictive Value of Tests en_US
dc.subject Reminder Systems en_US
dc.subject Research Design en_US
dc.subject Risk Factors en_US
dc.subject Text Messaging en_US
dc.subject Thermometry en_US
dc.subject Time Factors en_US
dc.subject Treatment Outcome en_US
dc.subject Type 2 ulcer en_US
dc.subject Young Adult en_US
dc.title Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1186/s13063-016-1333-1
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.01.05
dc.relation.issn 1745-6215


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