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

This study is not yet open for participant recruitment.
Verified September 2013 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
Elizabeth Burner, University of Southern California
ClinicalTrials.gov Identifier:
NCT01945996
First received: August 30, 2013
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Diabetes Mellitus
Behavioral: TExT MED
Behavioral: FANS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    dropout rate, number of messages received

  • Acceptability [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Did patients and loved ones enjoy the way of receiving information? Would they recommend it to a family member or friend?


Secondary Outcome Measures:
  • Lifestyle choices [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Physical Activity Medication adherence Diet choices Diabetes self-care activities

  • Knowledge [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Diabetes Knowledge Test

  • Self-efficacy [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Diabetes Empowerment Scale - Short Form

  • Problem areas in diabetes scale [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    Problem areas in diabetes scale is a measure of mental health problems that patient experience related to their diabetes

  • Glycemic Control [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    glycosylated hemoglobin A1c

  • Body Mass Index [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ]
    height and weight measurements


Estimated Enrollment: 120
Study Start Date: September 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01945996

Locations
United States, California
LAC+USC Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Elizabeth Burner, MD MPH    323-226-6667    eburner@usc.edu   
Principal Investigator: Elizabeth Burner, MD MPH         
Sponsors and Collaborators
University of Southern California
  More Information

Publications:
Responsible Party: Elizabeth Burner, Assistant Professor of Clinical Emergency Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT01945996     History of Changes
Other Study ID Numbers: HS-13-00382, KL2TR000131
Study First Received: August 30, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Hispanic Americans
Cellular Phone
Behavior

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

ClinicalTrials.gov processed this record on April 17, 2014