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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04227379
• Other study ID #: IIR 17-087
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Stephanie L Shimada, PhD
• Phone: (781) 687-2208
• Email: Stephanie.Shimada[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois
United States	North Florida/South Georgia Veterans Health System, Gainesville, FL	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	LDL	Secondary outcomes include LDL. These data will be pulled from the electronic medical record data.	6 month follow up
Secondary	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
Secondary	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
Secondary	blood pressure control	Secondary outcomes include blood pressure control. These data will be pulled from the electronic medical record data.	6 month follow up