Design and patient characteristics of the randomized controlled trial TExT-MED + FANS A test of mHealth augmented social support added to a patient-focused text-messaging intervention for emergency department patients with poorly controlled diabetes

Abstract Although diabetes is a nationwide epidemic, US Latinos are a particularly vulnerable population. Culturally appropriate interventions can combat this disparity, especially those that increase social support. However, these interventions face significant cost and time barriers, which mHealth (mobile health) may overcome. This trial examines the benefit of adding social support to an existing text-message based, patient-focused mHealth intervention for emergency department patients with poorly controlled diabetes. Family members and friends of patients were randomized to mHealth augmented social support training (daily text-messages that synchronize with the patient messages) or a pamphlet based training (the same content mailed to their house.) We hypothesize that patients who received mHealth augmented social support will have a larger improvement in diabetes management (glycosylated hemoglobin or A1C) than those receiving standard support at six-months, and that improvement will be sustained at twelve-months. Secondary patient outcomes are clinical (weight, blood pressure), behavioral (medication adherence, self-care activities) and psychosocial (general and diabetes-specific social support, self-efficacy, diabetes-related distress, depression, fatalism and quality of life). We screened 2004 patients and enrolled 166 patient/supporter dyads. 70% of patients are Spanish-speaking, 51% female, with a mean A1C of 10.8. We employed innovative measures to remotely enroll family members and support a bilingual population, which will assist other investigators in design of similar trials. The findings of our trial will have real-world applicability for clinicians, health system administrators, health educators and mHealth developers who aim to improve the health of this vulnerable population.