Your session is about to expire
← Back to Search
Texting Intervention for Diabetes
N/A
Waitlist Available
Led By Stephanie L Shimada, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month follow up
Awards & highlights
No Placebo-Only Group
Summary
This trial will help to develop a new customizable, interactive texting intervention called DD-TXT 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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-medical interventions (texting programs), there aren't typical medication side effects. However, participants may experience stress or frustration if they encounter difficulties using the technology.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HbA1c percent time in control
Secondary study objectives
LDL
blood pressure control
self-reported adherence to diabetes self-care recommendations (SCI-R)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DD-TXTExperimental Treatment1 Intervention
Participants in this group were signed up for an interactive, tailored self-management texting protocol (DD-TXT). The DD-TXT protocol consisted of the same daily educational content as the DSE 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. DD-TXT participants also received a once monthly message asking whether the messages had been helpful.
Group II: DSEActive Control1 Intervention
Participants in the comparison condition were signed up for a one-way education-only protocol called Diabetes Skilled Education-Only (DSE). DSE was 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. DSE messages could not be customized. There was no interactive content for the DSE arm other than a once monthly message asking whether the messages had been helpful.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,300 Total Patients Enrolled
Stephanie L Shimada, PhDPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA
1 Previous Clinical Trials
275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood sugar has not been well controlled for at least half of the 6 months before joining the study.I am a veteran with type 2 diabetes receiving care through the VHA.You need to have had two HbA1c lab tests in the year before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: DD-TXT
- Group 2: DSE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.