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Clinical Trials/NCT01945996
NCT01945996
Completed
Not Applicable

Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter

University of Southern California1 site in 1 country44 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
University of Southern California
Enrollment
44
Locations
1
Primary Endpoint
Acceptability 2: Would Patients Recommend the Program to Family or Friends?
Status
Completed
Last Updated
7 years ago

Overview

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.

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 (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) 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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
May 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elizabeth Burner

Assistant Professor of Clinical Emergency Medicine

University of Southern California

Eligibility 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

Outcomes

Primary Outcomes

Acceptability 2: Would Patients Recommend the Program to Family or Friends?

Time Frame: 3 months follow up

Response to: Would you recommend TExT-MED FANS to family or friends?

Feasibility

Time Frame: 3 months after enrollment

Number of patients lost to follow-up

Acceptability

Time Frame: 3 months after enrollment

Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program?

Secondary Outcomes

  • Change in Problem Areas in Diabetes Scale(3 months after enrollment)
  • Body Mass Index(3 months after enrollment)
  • Diabetes Knowledge Test Scale(3 months after enrollment)
  • Change in Self-efficacy(3 months after enrollment)
  • Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - General Diet Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - Exercise Sub Score(3 months follow up)
  • Glycemic Control(3 months after enrollment)
  • Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score(3 months follow up)
  • Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score(3 months follow up)

Study Sites (1)

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