@Article{info:doi/10.2196/10009,
author="Wang, Jing
and Coleman, Deidra Carroll
and Kanter, Justin
and Ummer, Brad
and Siminerio, Linda",
title="Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial",
journal="JMIR Res Protoc",
year="2018",
month="Apr",
day="02",
volume="7",
number="4",
pages="e10009",
keywords="wearable devices; connected health; mobile health; diabetes; randomized clinical trial; goal setting; lifestyle intervention; electronic health record; self-monitoring; behavior modification",
abstract="Background: Mobile and wearable technology have been shown to be effective in improving diabetes self-management; however, integrating data from these technologies into clinical diabetes care to facilitate behavioral goal monitoring has not been explored. Objective: The objective of this paper is to report on a study protocol for a pragmatic multi-site trial along with the intervention components, including the detailed connected health interface. This interface was developed to integrate patient self-monitoring data collected from a wearable fitness tracker and its companion smartphone app to an electronic health record system for diabetes self-management education and support (DSMES) to facilitate behavioral goal monitoring. Methods: A 3-month multi-site pragmatic clinical trial was conducted with eligible patients with diabetes mellitus from DSMES programs. The Chronicle Diabetes system is currently freely available to diabetes educators through American Diabetes Association--recognized DSMES programs to set patient nutrition and physical activity goals. To integrate the goal-setting and self-monitoring intervention into the DSMES process, a connected interface in the Chronicle Diabetes system was developed. With the connected interface, patient self-monitoring information collected from smartphones and wearable fitness trackers can facilitate educators' monitoring of patients' adherence to their goals. Feasibility outcomes of the 3-month trial included hemoglobin A1c levels, weight, and the usability of the connected system. Results: An interface designed to connect data from a wearable fitness tracker with a companion smartphone app for nutrition and physical activity self-monitoring into a diabetes education electronic health record system was successfully developed to enable diabetes educators to facilitate goal setting and monitoring. A total of 60 eligible patients with type 2 diabetes mellitus were randomized into either group 1) standard diabetes education or 2) standard education enhanced with the connected system. Data collection for the 3-month pragmatic trial is completed. Data analysis is in progress. Conclusions: If results of the pragmatic multi-site clinical trial show preliminary efficacy and usability of the connected system, a large-scale implementation trial will be conducted. Trial Registration: ClinicalTrials.gov NCT02664233; https://clinicaltrials.gov/ct2/show/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5) ",
issn="1929-0748",
doi="10.2196/10009",
url="http://www.researchprotocols.org/2018/4/e10009/",
url="https://doi.org/10.2196/10009",
url="http://www.ncbi.nlm.nih.gov/pubmed/29610111"
}