Clinical trial NCT04227379: Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
Official title: Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: text messaging
Health Equity
Health Care Quality, Access, and Evaluation
self-management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-01-13
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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)

Primary outcomes:
measure: HbA1c percent time in control
timeFrame: 6 month follow up
Secondary outcomes:
measure: self-reported adherence to diabetes self-care recommendations (SCI-R)
timeFrame: 6 month follow up
measure: LDL
timeFrame: 6 month follow up
measure: self-reported diabetes self-efficacy
timeFrame: 6 month follow up
measure: self-reported diabetes distress
timeFrame: 6 month follow up
measure: blood pressure control
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Bedford
country: United States
facility: VA Bedford HealthCare System, Bedford, MA
state: Massachusetts
Study officials:
affiliation: VA Bedford HealthCare System, Bedford, MA
name: Stephanie L Shimada, PhD
role: PRINCIPAL_INVESTIGATOR
References: