Diabetes Disparities: Texting to Extend Treatment (DD-TXT)

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT04227379
• Lead Sponsor: VA Office of Research and Development

Brief Summary

One way to help Veterans improve their diabetes control is through the use of technology to help provide information, motivation, and reminders necessary to support diabetes self-management. The study will seek input from diverse groups of Veterans living with diabetes to help develop a new customizable, interactive texting intervention that allows Veterans to choose what kinds of diabetes self-management support they need, and when. This diabetes support will be provided to Veterans through "Annie for Veterans", a VA texting system for self-management support. Patients will be randomized to receive a once-daily standard diabetes self-management texting intervention called DSMS based on standard diabetes self-management education content or a customizable, patient-centered diabetes self-management support intervention with additional features called DSMS Plus (DSMS+) in order to test the comparative effectiveness of these two texting interventions.

Detailed Description

Type 2 Diabetes is a common, complex health condition which can result in many serious and costly health complications if not treated and controlled properly. One in four Veterans are diagnosed with Type 2 Diabetes. Vulnerable Veterans, such as minority, low-income, or rural Veterans, and Veterans with comorbid mental health diagnoses, are disproportionately affected and are less likely to have their diabetes under control. The goal of this study, using a randomized comparative effectiveness design, was to test the comparative effectiveness of an interactive, customizable diabetes self-management support texting protocol (DSMS+), versus a standardized education-only intervention (DSMS) in a sample of Veterans with uncontrolled diabetes.

The team will invited Veterans age 18 years and above who were actively receiving care at the study sites (as determined by upcoming scheduled appointment) who had uncontrolled glucose (HbA1c \>= 8.0% for at least 50% of the most recent 6 months). Participants who met these conditions and enrolled in the study were randomized to one of two study arms: DSMS or DSMS+. Both arms received text-based diabetes self-management support for 6 months. The primary outcome was HbA1c percent time in control. Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R), diabetes self-efficacy, diabetes distress, LDL, and blood pressure control. The team hypothesized that the customizable texting intervention (DSMS+) would result in better proximal health outcomes and diabetes self-management behaviors vs a standardized, education-only protocol (DSMS).

Please note that we previously referred to DSMS as DSE (diabetes standardized education) and DSMS+ as DD-TXT (Diabetes Disparities: Texting to Extend Treatment) after the trial name. We updated the names to better clarify that both are diabetes self-management support texting interventions, with DSMS+ having additional, customizable and interactive content that patients can choose from.

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2023-01-30
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

• Veterans
• Active VHA patients with type 2 diabetes
• Had at least 4 VA outpatient encounters in the previous year
• Have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in Aim 1 DD-TXT development
• Have HbA1c lab data (2+ values) in the 12 months prior to RCT recruitment.
• Have inadequate glycemic control for at least 50% of the 6 months before invitation to participate.

Exclusion Criteria

• Non-Veterans
• Not having access to their own or a cohabiting family member's cell phone or smartphone for participation
• Not willing and able to text
• A visual impairment that would prevent them from reading or replying to text messages
• Cognitively incapable of consent to participate (Failure of Short Blessed Test)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c percent time in control	6 month follow up	The investigators will examine the changes in HbA1c percent time in control. These data will be calculated using HbA1c measures pulled from the electronic medical record data.

Secondary Outcome Measures

Name	Time	Method
self-reported adherence to diabetes self-care recommendations (SCI-R)	6 month follow up	Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R). These will be collected from the patient via a questionnaire conducted over the phone.
LDL	6 month follow up	Secondary outcomes include LDL. These data will be pulled from the electronic medical record data.
self-reported diabetes self-efficacy	6 month follow up	Secondary outcomes include self-reported adherence to diabetes self-efficacy. These will be collected from the patient via a questionnaire conducted over the phone.
self-reported diabetes distress	6 month follow up	Secondary outcomes include self-reported diabetes distress. These will be collected from the patient via a questionnaire conducted over the phone.
blood pressure control	6 month follow up	Secondary outcomes include blood pressure control. These data will be pulled from the electronic medical record data.

Trial Locations

Locations (3)

North Florida/South Georgia Veterans Health System, Gainesville, FL; 🇺🇸 Gainesville, Florida, United States

Jesse Brown VA Medical Center, Chicago, IL; 🇺🇸 Chicago, Illinois, United States

VA Bedford HealthCare System, Bedford, MA; 🇺🇸 Bedford, Massachusetts, United States