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Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes (TExT-MED)

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily text messages
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) ≥18 years old 2) have Type 2 diabetes 3) have a text message capable mobile phone 4) know how to receive text messages 5) speak and read English or Spanish and 6) have a HbA1C ≥8%.

Exclusion Criteria:

1) overt psychosis 2) unable to provide informed consent and 3) pregnancy.

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text messages

Control

Arm Description

Patients randomized to this arm will receive daily text messages to their mobile phones consisting of educational materials, motivational materials, trivia questions, and challenges to engage in healthy lifestyle choices

Outcomes

Primary Outcome Measures

Hemoglobin A1C at 6 months

Secondary Outcome Measures

DIet/ Weight Loss
Diabetes self-efficacy/empowerment
Diabetes knowledge

Full Information

First Posted
July 25, 2011
Last Updated
June 18, 2013
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT01403831
Brief Title
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes
Acronym
TExT-MED
Official Title
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a technologically simple solution using unidirectional daily text messages to consisting of educational materials, trivia questions and challenges promoting healthy lifestyle choices and reminders to check blood sugar, take medications and go to clinic appointments. The investigators believe TExT-MED will improve health outcomes including blood glucose control and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and can be quickly adapted to other practice environments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Text messages
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive daily text messages to their mobile phones consisting of educational materials, motivational materials, trivia questions, and challenges to engage in healthy lifestyle choices
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Daily text messages
Intervention Description
2-3 times daily text messages regarding diabetes care and healthy lifestyle choices
Primary Outcome Measure Information:
Title
Hemoglobin A1C at 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
DIet/ Weight Loss
Time Frame
6 months
Title
Diabetes self-efficacy/empowerment
Time Frame
6 months
Title
Diabetes knowledge
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) ≥18 years old 2) have Type 2 diabetes 3) have a text message capable mobile phone 4) know how to receive text messages 5) speak and read English or Spanish and 6) have a HbA1C ≥8%. Exclusion Criteria: 1) overt psychosis 2) unable to provide informed consent and 3) pregnancy.
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22524591
Citation
Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.
Results Reference
derived

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Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes

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