Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers

Study protocol for a randomized controlled trial

Maria Lazo-Porras, Antonio Bernabe-Ortiz, Katherine A. Sacksteder, Robert H. Gilman, German Malaga, David G Armstrong, J. Jaime Miranda

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Article number206
JournalTrials
Volume17
Issue number1
DOIs
StatePublished - Apr 19 2016

Fingerprint

Thermometry
Diabetic Foot
Telemedicine
Foot
Randomized Controlled Trials
Cell Phones
Nurses
Foot Ulcer
Equipment and Supplies
Peru
Temperature
Aptitude
Diabetic Neuropathies
Diabetes Complications
Patient Compliance
Self Care
Ambulatory Care Facilities
Informed Consent
Amputation
Tertiary Care Centers

Keywords

  • Diabetes mellitus
  • Diabetic neuropathies
  • MHealth
  • Thermometry
  • Type 2 ulcer

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers : Study protocol for a randomized controlled trial. / Lazo-Porras, Maria; Bernabe-Ortiz, Antonio; Sacksteder, Katherine A.; Gilman, Robert H.; Malaga, German; Armstrong, David G; Miranda, J. Jaime.

In: Trials, Vol. 17, No. 1, 206, 19.04.2016.

Research output: Contribution to journalArticle

Lazo-Porras, Maria ; Bernabe-Ortiz, Antonio ; Sacksteder, Katherine A. ; Gilman, Robert H. ; Malaga, German ; Armstrong, David G ; Miranda, J. Jaime. / Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers : Study protocol for a randomized controlled trial. In: Trials. 2016 ; Vol. 17, No. 1.
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