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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanjay Arora, University of Southern California
ClinicalTrials.gov Identifier:
NCT01403831
First received: July 25, 2011
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention
Diabetes
Other: Daily text messages

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Hemoglobin A1C at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DIet/ Weight Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes self-efficacy/empowerment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Diabetes knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403831

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

No publications provided by University of Southern California

Additional 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
Study First Received: July 25, 2011
Last Updated: June 18, 2013
Health Authority: United States: University of Southern California Department of Emergency Medicine

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

ClinicalTrials.gov processed this record on July 20, 2014