TExT-MED + FANS Full Trial (TExTMED+FANSII)

University of Southern California

Status and phase: Completed; Phase 2

Conditions: Diabetes

Treatments: Behavioral: TExT-MED; Behavioral: FANS

Study type: Interventional

Funder types: Other

Identifiers

NCT03178773

HS-17-00406

Details and patient eligibility

About

This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes

Full description

Diabetes has disproportionately affected the Latino population. TExT-MED (Trial to Examine Text Message for Emergency Department Patients with Diabetes) is a locally designed, successful mobile health (mHealth) intervention for low income Latinos with diabetes. Social support interventions have likewise been successful at improving patient self-efficacy and disease management but are limited in scale due to two key obstacles: 1) requirements of in-person training of family and friends to be supporters and 2) the need to coordinate schedules and physical location between the patient and their supporter. mHealth can overcome these obstacles by allowing supporters to be trained remotely via a mobile platform and by allowing communication between a patient and supporter to occur at any time or place. The proposed intervention leverages the success of TExT-MED by augmenting the program with a social supporter that each patient can select from his or her own social support system (Family And friend Network Supporters (FANS)), creating TExT-MED+FANS. This is a 12 month, randomized study of this intervention. At the completion of the trial, we will evaluate the user experience with TExT-MED+FANS, and the impact of TExT-MED+FANS on patient motivation, self-efficacy and behaviors through a qualitative analysis of semi-structured individual interviews.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18
• HbA1c>8.5
• Social support person identified and contacted

Exclusion criteria

• unable to consent
• does not speak/read English or Spanish

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

TExT-MED only

Active Comparator group

Description:

Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.

Treatment:

Behavioral: TExT-MED

TExT-MED+FANS

Experimental group

Description:

Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.

Treatment:

Behavioral: TExT-MED

Behavioral: FANS