TExT-MED + FANS Full Trial

NCT ID: NCT03178773

Last Updated: 2021-08-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2019-12-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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TExT-MED only

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.

Group Type ACTIVE_COMPARATOR

TExT-MED

Intervention Type BEHAVIORAL

messages designed to inspire motivation and behavior change

TExT-MED+FANS

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.

Group Type EXPERIMENTAL

TExT-MED

Intervention Type BEHAVIORAL

messages designed to inspire motivation and behavior change

FANS

Intervention Type BEHAVIORAL

SMS delivered messages to family members to improve social support

Interventions

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TExT-MED

messages designed to inspire motivation and behavior change

Intervention Type BEHAVIORAL

FANS

SMS delivered messages to family members to improve social support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Burner

Assistant Professor of Clinical Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LAC+USC Medicine Center Emergency Department

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Burner E, Hazime D, Menchine M, Mack W, Mercado J, Aleman A, Hernandez Saenz A, Arora S, Wu S. mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial. JMIR Diabetes. 2025 Apr 23;10:e56934. doi: 10.2196/56934.

Reference Type DERIVED
PMID: 40266665 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HS-17-00406

Identifier Type: -

Identifier Source: org_study_id

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