Outcomes of TExT-MED+FANS: a Phase III Randomized Unblinded Trial of mHealth Augmented Social Support vs Standard Social Support in Combination with a mHealth Curriculum for Safety-Net ED Patients with Diabetes (Preprint)

Abstract

: Mobile health (mHealth) is a low-cost method to improve health for patients with diabetes seeking care in safety-net emergency departments (EDs). Additions of social support to mHealth interventions could further enhance diabetes self-management.

We assessed outcomes of an unblinded parallel equal allocation randomized phase III trial that tested a social support mHealth intervention to improve ED patients diabetes self-management.

Patients with A1C≥8.5%mg/dL and a text-capable phone were recruited during their ED visit. They received 6 months of the TExT-MED diabetes self-management mHealth program. Supporters were randomized to receive either 1) Family and Friends Network Support (FANS) intervention: daily text messages guiding supporters to provide diabetes-related social support or 2) an active control: pamphlet-augmented social support with FANS content. A1C, self-reported diabetes self-care activities, medication adherence, and safety events were measured. Mixed effects linear regression models analyzed group differences at the end of the intervention (6 months) and post intervention phase (12 months).

166 patients were randomized, with 97 (58%) followed at 6 months and 106 (64%) at 12 months. Both intervention groups showed significant A1C improvements (combined group change 1.36%mg/dl, (95% CI 0.87 to 1.83)), with no group difference (group mean difference = 0.14%mg/dl (95% CI 0.83 to -1.11)). No differences were observed in safety events.

Six-month change in A1C did not differ by mode of social support in persons using an existing patient-focused mHealth diabetes self-management program. Newly diagnosed diabetes patients benefiting most from mHealth augmented social support.

ClinicalTrials.gov (NCT03178773)

RR2-10.1016/j.cct.2019.03.003