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

A registered trial from ClinicalTrials.gov: Identifier NCT02373592

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From the article 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.

Communication-Focused Technologies: Health Messages for HIV-Positive Men Who Have Sex With Men—Final Report.

Report of an AHRQ-funded study (Prepared by RTI International, under Contract No. 290-06-0001-7). AHRQ Publication No. 11-0063-EF.

Analyzed by M'lynda Owens 0 14804 Article rating: No rating

From the AHRQ summary page: This project, one of the Agency for Healthcare Research and Quality's Accelerating Change and Transformation in Organizations and Networks (ACTION) contracts, developed, implemented, and evaluated a short message service (SMS) intervention. The intervention targeted HIV-positive men who have sex with men (MSM) and who were at least 25-years-old. The aim of the messages was to: improve adherence to medication regimens; improve attendance at appointments; reduce risk-taking behaviors; enhance social support, general health and well-being; and increase involvement of individuals with their health care.

Objectives from the AHRQ summary: The main objectives of the project were to: 

  1. Conduct a thorough review of existing literature, paying close attention to work that has been completed on innovative uses of text messaging in health communication strategies.
  2. Develop and implement an SMS-based intervention to improve health care quality and outcomes by providing tailored health communication messages to HIV-positive patients who are treated in ambulatory care settings.
  3. Conduct a process evaluation on implementation and determine the feasibility and potential for implementing the intervention in other ambulatory care settings.
  4. Conduct an outcome evaluation that focuses on patient satisfaction and the impact of the intervention on targeted knowledge, attitudes, beliefs, intentions and behaviors, health care quality, and outcomes measures.

mFHAST implication: Messaging targeting special (protected class) populations can be done 

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