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Clinical Trial 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 DD-TXT, 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", a new VA texting system for self-management support. Patients will be randomized to receive DD-TXT or an education-only texting intervention called DSE that is based on a diabetes skills workbook in order to test the comparative effectiveness of DD-TXT.


Clinical Trial 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, is to test the comparative effectiveness of an interactive, tailored self-management texting protocol (DD-TXT), versus a traditional education-only intervention (DSE) in a sample of Veterans with uncontrolled diabetes. The investigators will recruit from Veterans age 18 years and above who are actively receiving care at the study sites (as determined by upcoming scheduled appointment) who have uncontrolled glucose (HbA1c >= 8.0% for at least 50% of the most recent 6 months). Participants who meet these conditions and enroll in the study will be randomized to one of two groups. Those randomized to the intervention group will receive text messages from the DD-TXT protocol for 6 months, and those in the comparison group will receive text messages from DSE, a diabetes skills education-only texting protocol, for 6 months. The primary outcome will be 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 investigators hypothesize that DD-TXT will result in better proximal health outcomes and diabetes self-management behaviors vs an education-only protocol (DSE). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04227379
Study type Interventional
Source VA Office of Research and Development
Contact Stephanie L Shimada, PhD
Phone (781) 687-2208
Email Stephanie.Shimada@va.gov
Status Recruiting
Phase N/A
Start date January 30, 2023
Completion date November 1, 2024

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