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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Intervention 1- DD-TXT; Behavioral: Comparison - DSE

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, 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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie L Shimada, PhD; Phone Number: (781) 687-2208; Email: Stephanie.Shimada@va.gov
• Study Contact Backup: Name: Timothy P Hogan, PhD MS BS; Phone Number: (781) 687-3181; Email: timothy.hogan@va.gov

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608-1135
      • Enrolling by invitation
      • North Florida/South Georgia Veterans Health System, Gainesville, FL
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Enrolling by invitation
      • Jesse Brown VA Medical Center, Chicago, IL
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730-1114
      • Recruiting
      • VA Bedford HealthCare System, Bedford, MA
      • Contact: John M Wells, PhD; Phone Number: 781-687-2924; Email: John.Wells5@va.gov
      • Principal Investigator: Stephanie L Shimada, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veterans
• active VHA patients with type 2 diabetes
• have 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
• must have access to their own or a cohabiting family member's cell phone or smartphone for participation. --must be willing and able to text, not have any visual impairment that would prevent them from reading or replying to text messages, and must be cognitively capable of consent to participate.
• must also have HbA1c lab data (2+ values) for the 12 months prior to RCT recruitment.
• must have inadequate glycemic control for at least 50% of the 6 months before enrollment.

Exclusion Criteria:

-Non-Veterans

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DD-TXT; Participants in this group will be signed up for an interactive, tailored self-management texting protocol (DD-TXT). The DD-TXT protocol will consist of: Core Messaging: Customizable core modules on medication management, blood sugar and blood pressure monitoring, preventive care, problem solving, appointment reminders, administrative messages; and Optional Messaging: A library of patient-selected modules (e.g. nutrition, physical activity, weight management, emotional coping, goal setting) designed to motivate and educate.	Behavioral: Intervention 1- DD-TXT; Participants in this group will be signed up for an interactive, tailored self-management texting protocol (DD-TXT). The DD-TXT protocol will consist of: Core Messaging: Customizable core modules on medication management, blood sugar and blood pressure monitoring, preventive care, problem solving, appointment reminders, administrative messages; and Optional Messaging: A library of patient-selected modules (e.g. nutrition, physical activity, weight management, emotional coping, goal setting) designed to motivate and educate.
Active Comparator: DSE; The comparison condition will be signed up for a one-way education-only protocol called Diabetes Skilled Education-Only (DSE). DSE contains only one-way educational content consisting only of content from the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", which was created in alignment with VA/DoD diabetes guidelines and is recommended for patients as part of usual care. Everyone in the DSE arm will receive the same daily text messages taken verbatim or almost verbatim from the content of the workbook but shortened to fit the 160-character limit of a text message. There will be no customizable or interactive content for the DSE arm.	Behavioral: Comparison - DSE; The comparison condition will be signed up for a one-way education-only protocol called Diabetes Skilled Education-Only (DSE). DSE contains only one-way educational content consisting only of content from the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", which was created in alignment with VA/DoD diabetes guidelines and is recommended for patients as part of usual care. Everyone in the DSE arm will receive the same daily text messages taken verbatim or almost verbatim from workbook content but shortened to fit the 160-character limit of a text message (See Appendix 3 for sample messages from workbook). There will be no customizable or interactive content for the DSE arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Stephanie L Shimada, PhD, VA Bedford HealthCare System, Bedford, MA

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: text messaging; Health Equity; Health Care Quality, Access, and Evaluation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IIR 17-087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No