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

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT01403831
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Other: Daily text messages	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Text messages 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	Other: Daily text messages; 2-3 times daily text messages regarding diabetes care and healthy lifestyle choices
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1C at 6 months [6 months]

Secondary Outcome Measures

1. DIet/ Weight Loss [6 months]

2. Diabetes self-efficacy/empowerment [6 months]

3. Diabetes knowledge [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanjay Arora, PI, University of Southern California
• ClinicalTrials.gov Identifier: NCT01403831
• Other Study ID Numbers: HS-11-00084; Mobilizing for Health
• First Posted: Jul 27, 2011
• Last Update Posted: Jun 19, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Diabetes Mellitus; Emergencies

Study Results

No Results Posted as of Jun 19, 2013