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

NCT04227379 | Completed

• 1 other identifier: IIR 17-087
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

text messaging; Health Equity; Health Care Quality, Access, and Evaluation; self-management

Outcome Measures

Primary Outcomes (1)

• HbA1c percent time in control

  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.

  6 month follow up

Secondary Outcomes (5)

• self-reported adherence to diabetes self-care recommendations (SCI-R)

  6 month follow up

• LDL

  6 month follow up

• self-reported diabetes self-efficacy

  6 month follow up

• self-reported diabetes distress

  6 month follow up

• blood pressure control

  6 month follow up

Study Arms (2)

DSMS+ (DSMS Plus)

EXPERIMENTAL

Participants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging that supported their diabetes self-management goals. Patients could customize the timing and frequency of their messages. DSMS+ participants also received a once monthly message asking whether the messages had been helpful.

Behavioral: Intervention 1- DSMS+

DSMS

ACTIVE COMPARATOR

Participants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful.

Behavioral: Comparison - DSMS

Interventions

Intervention 1- DSMS+ BEHAVIORAL

Participants in this group were signed up for an interactive, patient-centered, and customizable diabetes self-management support texting intervention (DSMS+). This arm received the same daily educational content as the DSMS arm augmented by the following: regular two-way check-in messages about diabetes self-management behaviors, an invitation to receive messages written by other Veterans living with diabetes on demand, and a menu of optional and customizable modules (e.g., medication reminders, blood sugar and blood pressure monitoring,: physical activity reminders, weight management, and goal setting) from which participants could select messaging th

Also known as: DD-TXT

DSMS+ (DSMS Plus)

Comparison - DSMS BEHAVIORAL

Participants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Self-Management Support (DSMS), comprised of 6 months of once daily one-way text messages covering standard diabetes self-management education content. Starting with the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, we enhanced the educational content by incorporating Veteran input through a co-design process with Veterans living with diabetes and expert clinician review. DSMS messages could not be customized. There was no interactive content for the DSMS arm other than a once monthly message asking whether the messages had been helpful.

Also known as: DSE

DSMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephanie L Shimada, PhD

  VA Bedford HealthCare System, Bedford, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants received a diabetes self-management support texting intervention but they were not explicitly told whether their intervention was part of the experimental (DSMS+) or comparison (DSMS) arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Patients who consented to participate were asked to complete the baseline survey instruments. Participants were then randomized to a study arm, using a separate randomization table per site. Since women are underrepresented among VHA patients, the study staff recruited women first to oversample them, with the goal of 10-20% women at each site. The goal was to recruit 400 participants (200 per site). Participants in both arms were asked to complete a follow-up survey and interview after completing the 6-month texting intervention they were assigned.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: January 30, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)