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
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.


METHODS
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.


RESULTS
the primary outcome is foot ulceration, evaluated by a trained nurse, occurring at any point during the study.


CONCLUSIONS
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.


BACKGROUND
This study is registered in ClinicalTrials.gov: Identifier NCT02373592 .
CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendáriz 497, Miraflores, Lima 18, Peru.
Maria
M
Lazo-Porras
CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendáriz 497, Miraflores, Lima 18, Peru.|School of Public Health and Administration, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, Urb. Ingeniería, Lima 31, Peru.
Antonio
A
Bernabe-Ortiz
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 615 N Wolfe Street, Baltimore, MD, USA.
Katherine A
KA
Sacksteder
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, 615 N Wolfe Street, Baltimore, MD, USA.|Área de Investigación y Desarrollo, Asociación Benéfica PRISMA, Carlos Gonzales 251, Maranga, Lima 32, Peru.
Robert H
RH
Gilman
CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendáriz 497, Miraflores, Lima 18, Peru.|Department of Medicine, School of Medicine, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, Urb. Ingeniería, Lima 31, Peru.
German
G
Malaga
Southern Arizona Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona College of Medicine, Tucson, AZ, USA.
David G
DG
Armstrong
CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Av. Armendáriz 497, Miraflores, Lima 18, Peru. Jaime.Miranda@upch.pe.|Department of Medicine, School of Medicine, Universidad Peruana Cayetano Heredia, Av. Honorio Delgado 430, Urb. Ingeniería, Lima 31, Peru. Jaime.Miranda@upch.pe.
J Jaime
JJ
Miranda
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001831:Body Temperature; D040421:Cell Phone; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D017719:Diabetic Foot / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control*; D004867:Equipment Design; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D010568:Peru / Q000453:epidemiology; D011237:Predictive Value of Tests; D017010:Reminder Systems; D012107:Research Design; D012307:Risk Factors; D012648:Self Care; D017216:Telemedicine / Q000295:instrumentation; D060145:Text Messaging; D062125:Thermometry / Q000295:instrumentation; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
Diabetes mellitus; Diabetic neuropathies; Thermometry; Type 2 ulcer; mHealth