Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients (TExTMEDFANS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01945996
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : June 4, 2014
Information provided by (Responsible Party):
Elizabeth Burner, University of Southern California

Brief Summary:
In this study, an existing mobile health intervention to improve diabetes self-management will be combined with a social support module and tested for feasibility. The investigators hypothesize that this combination will be feasible and acceptable to both patients and their loved ones.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: TExT MED Behavioral: FANS Not Applicable

Detailed Description:
This will be the first ever evaluation of a highly scalable and low-cost social support intervention for patients with diabetes delivered entirely via mobile phones. TExT-MED FANS will unite the benefits of mHealth (scalability, ease of access) and social support interventions (personalized motivation, emotional support). The Diabetes FANS text message based curriculum will make it easier for friends and family to become supporters. Additionally, augmenting TExT-MED with the FANS social support module will be more effective than TExT-MED alone. The personalized support of TExT-MED FANS will also be more effective than providing TExT-MED in combination with a community health worker supporter who lacks a pre-existing relationship with the patient. Through this innovative combination, I can create a more cost-effective and diffusible mHealth solution that maintains the personal connection of social support interventions. To date there has only been one study evaluating social support interventions for patients with diabetes using mHealth, but in this study participants were paired with other subjects with diabetes (not friends or family) and it required intensive face-to-face support group time. TExT-MED FANS will provide key insights into the utility of combining social support interventions delivered solely via mHealth in low-income Latino patients. These insights will help future interventions achieve maximal impact on diabetes and other chronic disease management.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter
Study Start Date : September 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Active Comparator: TExT-MED only
Patients will receive TExT-MED intervention, but supporters will not receive additional messages
Behavioral: TExT MED
educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
Experimental: TExT-MED FANS
Patients get TExT-MED intervention, supporter gets FANS curriculum
Behavioral: TExT MED
educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
Behavioral: FANS
supporter curriculum of messages, consisting of educational/motivational messages, and support challenges

Primary Outcome Measures :
  1. Feasibility [ Time Frame: 3 months after enrollment ]
    dropout rate, number of messages received

  2. Acceptability [ Time Frame: 3 months after enrollment ]
    Did patients and loved ones enjoy the way of receiving information? Would they recommend it to a family member or friend?

Secondary Outcome Measures :
  1. Lifestyle choices [ Time Frame: 3 months after enrollment ]
    Physical Activity Medication adherence Diet choices Diabetes self-care activities

  2. Knowledge [ Time Frame: 3 months after enrollment ]
    Diabetes Knowledge Test

  3. Self-efficacy [ Time Frame: 3 months after enrollment ]
    Diabetes Empowerment Scale - Short Form

  4. Problem areas in diabetes scale [ Time Frame: 3 months after enrollment ]
    Problem areas in diabetes scale is a measure of mental health problems that patient experience related to their diabetes

  5. Glycemic Control [ Time Frame: 3 months after enrollment ]
    glycosylated hemoglobin A1c

  6. Body Mass Index [ Time Frame: 3 months after enrollment ]
    height and weight measurements

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • type II diabetes
  • HbA1c >or=8 at enrollment
  • speak English or Spanish
  • has support person willing to participate

Exclusion Criteria:

  • unable to consent
  • pediatric patient

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 identifier (NCT number): NCT01945996

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

Responsible Party: Elizabeth Burner, Assistant Professor of Clinical Emergency Medicine, University of Southern California Identifier: NCT01945996     History of Changes
Other Study ID Numbers: HS-13-00382
KL2TR000131 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by Elizabeth Burner, University of Southern California:
Hispanic Americans
Cellular Phone

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases