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
Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio, Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio
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://ichgcp.net/clinical-trials-registry/NCT02664233 (Archived by WebCite at http://www.webcitation.org/6yDEwXHo5).
Keywords: behavior modification; connected health; diabetes; electronic health record; goal setting; lifestyle intervention; mobile health; randomized clinical trial; self-monitoring; wearable devices.
Conflict of interest statement
Conflicts of Interest: BU is the President of Flipside Media. Flipside Media was the contractor that originally developed Chronicle Diabetes for the University of Pittsburgh Medical Center. Flipside Media is currently the contractor that maintains Chronicle Diabetes for the American Diabetes Association. Neither BU nor Flipside Media have any financial interest in Chronicle Diabetes.
©Jing Wang, Deidra Carroll Coleman, Justin Kanter, Brad Ummer, Linda Siminerio. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2018.
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