366 Participants Needed

Texting Intervention for Diabetes

(DD-TXT Trial)

Recruiting at 3 trial locations
SL
TP
Overseen ByTimothy P Hogan, PhD MS BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a texting system to support diabetes management, so it's likely you can continue your current treatment.

What data supports the effectiveness of the treatment DD-TXT, DSE for diabetes?

Research shows that sending educational and motivational text messages can improve diabetes management by increasing knowledge, self-care, and medication adherence, leading to better blood sugar control.12345

Is the texting intervention for diabetes safe for humans?

The texting intervention for diabetes, used in various programs, has been shown to be a low-cost and feasible way to support diabetes management and prevention. While specific safety data is not detailed, the intervention involves sending supportive text messages, which is generally considered safe for human use.678910

How is the DD-TXT treatment for diabetes unique?

The DD-TXT treatment is unique because it uses personalized text messages to support diabetes management, offering a low-cost, instant, and widely accessible way to help patients manage their condition through reminders and educational prompts tailored to their needs.910111213

What is the purpose of this trial?

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.

Research Team

SL

Stephanie L Shimada, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Eligibility Criteria

This trial is for Veterans with type 2 diabetes who have struggled to control their blood sugar levels. They must be scheduled for a future appointment, able to text, and not visually impaired. Participants need access to a cell phone or smartphone and at least four VA outpatient visits in the past year.

Inclusion Criteria

Have a future appointment scheduled, and not be hospitalized or institutionalized or have participated in Aim 1 DD-TXT development
Your blood sugar has not been well controlled for at least half of the 6 months before joining the study.
Have had at least 4 VA outpatient encounters in the previous year
See 4 more

Exclusion Criteria

Non-Veterans

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the DD-TXT or DSE texting protocol for diabetes self-management for 6 months

6 months

Follow-up

Participants are monitored for changes in HbA1c, self-reported adherence, diabetes distress, LDL, and blood pressure control

6 months

Treatment Details

Interventions

  • DD-TXT
  • DSE
Trial Overview The study tests DD-TXT, an interactive texting intervention that helps Veterans manage their diabetes via 'Annie', a VA texting system. It's compared against DSE, an education-only text based on a diabetes workbook. Patients are randomly assigned to one of these two interventions.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: DSMS+ (DSMS Plus)Experimental Treatment1 Intervention
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.
Group II: DSMSActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Findings from Research

A new trial is testing the effectiveness of SMS text messages designed to improve medication adherence in adults with type 2 diabetes, involving 958 participants over 12 months, aiming to reduce cardiovascular risk.
Preliminary feasibility studies indicate that these SMS messages are acceptable to patients and successfully influence medication adherence, setting the stage for this larger trial to assess their impact compared to usual care.
Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.Farmer, A., Jones, L., Newhouse, N., et al.[2023]
A meta-analysis of 10 studies involving 380 interventions showed that distance education and SMS reminders significantly reduced HbA1c levels in type-2 diabetes patients, with an overall effect size of -0.49%.
The same interventions also improved medication adherence, with a strong effect size of 0.96, indicating that texting reminders can be an effective strategy for managing diabetes over the first 6 months.
Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies.Zhuang, Q., Chen, F., Wang, T.[2022]
Only 9 out of 792 studies on SMS interventions for type 2 diabetes management in the U.S. met the inclusion criteria, highlighting a significant gap in research on this topic.
While 63% of participants in these studies were non-white, there was a lack of cultural adaptations and comprehensive sociodemographic data, indicating a need for more inclusive and tailored interventions for diverse populations.
Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States.Eyler, AA., Gachupin, FC., Johnston, SL., et al.[2022]

References

Text Message Intervention for Latino Adults to Improve Diabetes Outcomes. [2022]
Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial. [2023]
Effectiveness of text message based, diabetes self management support programme (SMS4BG): two arm, parallel randomised controlled trial. [2022]
Digital messaging to support control for type 2 diabetes (StAR2D): a multicentre randomised controlled trial. [2022]
Effectiveness of short message service intervention to improve glycated hemoglobin control and medication adherence in type-2 diabetes: A meta-analysis of prospective studies. [2022]
Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States. [2022]
Supplemental Text Message Support With the National Diabetes Prevention Program: Pragmatic Comparative Effectiveness Trial. [2021]
The Development of Text Messages to Support People at Risk of Diabetes in Low-Resourced Communities: The South African Diabetes Prevention Programme. [2023]
Diabetes Text-Message Self-Management Support Program (SMS4BG): A Pilot Study. [2018]
Evaluation and Refinement of a Bank of SMS Text Messages to Promote Behavior Change Adherence Following a Diabetes Prevention Program: Survey Study. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Texting Adolescents in Repeat DKA and Their Caregivers. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Going mobile with diabetes support: a randomized study of a text message-based personalized behavioral intervention for type 2 diabetes self-care. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Computerized Automated Reminder Diabetes System (CARDS): e-mail and SMS cell phone text messaging reminders to support diabetes management. [2022]
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