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Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care

Primary Purpose

Diabetes Mellitus, Type 2, Obesity

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mobile and connected health
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Diabetes Mellitus, Type 2, obesity, self-monitoring, goal setting, mobile health, connected health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pittsburgh
  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Connected group

Usual diabetes education and care

Arm Description

Patients will use a smart phone and a fitness tracker for self-monitoring of diet and physical activity for 3 months; 3) Smart phones will provide feedback with graphical presentation of self-monitored information to patients; 4) Patient self-monitored information will be integrated into Chronicle Diabetes, so that educators will be able to view this information and give feedback in a follow-up visit.

Participants will receive standard diabetes education and care; each of the recruiting clinics offers diabetes self-management education programs.

Outcomes

Primary Outcome Measures

Change in HbA1c levels from baseline to 3 months
Glycemic control will be determined by HbA1c level. HbA1c will be measured using the A1c NOW self check system via a finger stick or extracted from clinical visit data.
Change in weight measures from baseline to 3 months
Participant weight will be measured via a weight scale or via self-report.

Secondary Outcome Measures

Usability of the connected interface technology as indicated by a System Usability Scale
The System Usability Scale measures patients' and educators' acceptability, satisfaction, and perceived usefulness of the intervention that is the focus of this study (that is, the connected interface technology within Chronicle Diabetes--Chronicle Diabetes is an electronic diabetes education documentation system to transfer smartphone and wristband collected self-monitoring diet and physical activity information from patients to diabetes educators). Patients and educators are asked to rate each usability item in the scale from 0 to 100.

Full Information

First Posted
December 9, 2015
Last Updated
October 29, 2016
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02664233
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
University of Pittsburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Obesity
Keywords
Diabetes, Diabetes Mellitus, Type 2, obesity, self-monitoring, goal setting, mobile health, connected health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Connected group
Arm Type
Experimental
Arm Description
Patients will use a smart phone and a fitness tracker for self-monitoring of diet and physical activity for 3 months; 3) Smart phones will provide feedback with graphical presentation of self-monitored information to patients; 4) Patient self-monitored information will be integrated into Chronicle Diabetes, so that educators will be able to view this information and give feedback in a follow-up visit.
Arm Title
Usual diabetes education and care
Arm Type
No Intervention
Arm Description
Participants will receive standard diabetes education and care; each of the recruiting clinics offers diabetes self-management education programs.
Intervention Type
Behavioral
Intervention Name(s)
Mobile and connected health
Intervention Description
Patients will use a smart phone and a fitness tracker for self-monitoring of diet and physical activity for 3 months; 3) Smart phones will provide feedback with graphical presentation of self-monitored information to patients; 4) Patient self-monitored information will be integrated into Chronicle Diabetes, so that educators will be able to view this information and give feedback in a follow-up visit.
Primary Outcome Measure Information:
Title
Change in HbA1c levels from baseline to 3 months
Description
Glycemic control will be determined by HbA1c level. HbA1c will be measured using the A1c NOW self check system via a finger stick or extracted from clinical visit data.
Time Frame
baseline and 3 months post enrollment
Title
Change in weight measures from baseline to 3 months
Description
Participant weight will be measured via a weight scale or via self-report.
Time Frame
baseline and 3 months post enrollment
Secondary Outcome Measure Information:
Title
Usability of the connected interface technology as indicated by a System Usability Scale
Description
The System Usability Scale measures patients' and educators' acceptability, satisfaction, and perceived usefulness of the intervention that is the focus of this study (that is, the connected interface technology within Chronicle Diabetes--Chronicle Diabetes is an electronic diabetes education documentation system to transfer smartphone and wristband collected self-monitoring diet and physical activity information from patients to diabetes educators). Patients and educators are asked to rate each usability item in the scale from 0 to 100.
Time Frame
3 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 2 diabetes Overweight or obese with an BMI > 25 Able to read and write English Own a smart phone that is Jawbone compatible Exclusion Criteria: 1. Currently undergoing current treatment for a severe psychiatric disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Wang, PhD, MPH, RN
Organizational Affiliation
The University of Texas Health Science Center at Houston, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29610111
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.
Results Reference
derived

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Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care

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