Clinical trial NCT02664233: Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care
Official title: Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: Diabetes
Diabetes Mellitus, Type 2
obesity
self-monitoring
goal setting
mobile health
connected health
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2016-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In order to facilitate the evidence-based goal setting and self-monitoring intervention into the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an electronic system provided available to the American Diabetes Association diabetes education programs, to set patient diet and physical activity goals, and connect patient self-monitoring information collected from smart phones and fitness trackers to Chronicle Diabetes system to facilitate educators' monitoring of patient adherence to their goals.

Detailed description: Specific Aim 1: To develop and test an interface with Chronicle Diabetes to transfer smartphone collected self-monitoring diet and physical activity information from patients to diabetes educators.

Specific Aim 2: To 2a) conduct usability testing and 2b) examine efficacy of this connected interface technology in a 3-month randomized clinical trial in 60 overweight or obese patients with type 2 diabetes in Houston, Texas and Pittsburgh, Pennsylvania.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with type 2 diabetes
2. Overweight or obese with an BMI \> 25
3. Able to read and write English
4. Own a smart phone that is Jawbone compatible

Exclusion Criteria:

1. Currently undergoing current treatment for a severe psychiatric disorder.

Primary outcomes:
measure: Change in HbA1c levels from baseline to 3 months
timeFrame: baseline and 3 months post enrollment
measure: Change in weight measures from baseline to 3 months
timeFrame: baseline and 3 months post enrollment
Secondary outcomes:
measure: Usability of the connected interface technology as indicated by a System Usability Scale
timeFrame: 3 months post enrollment
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Houston, School of Nursing
name: Jing Wang, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, Coleman DC, Kanter J, Ummer B, Siminerio L. 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. JMIR Res Protoc. 2018 Apr 2;7(4):e10009. doi: 10.2196/10009.