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

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ClinicalTrials.gov Identifier: NCT01403831
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Sanjay Arora, University of Southern California

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

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



Primary Outcome Measures :
  1. Hemoglobin A1C at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. DIet/ Weight Loss [ Time Frame: 6 months ]
  2. Diabetes self-efficacy/empowerment [ Time Frame: 6 months ]
  3. Diabetes knowledge [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403831


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanjay Arora, PI, University of Southern California
ClinicalTrials.gov Identifier: NCT01403831     History of Changes
Other Study ID Numbers: HS-11-00084
Mobilizing for Health ( Other Grant/Funding Number: McKesson Foundation )
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Emergencies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes