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Texting Intervention for Diabetes
N/A
Recruiting
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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HbA1c percent time in control
Secondary outcome measures
LDL
blood pressure control
self-reported adherence to diabetes self-care recommendations (SCI-R)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DD-TXTExperimental Treatment1 Intervention
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.
Group II: DSEActive Control1 Intervention
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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,611 Previous Clinical Trials
3,304,884 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study currently recruiting participants?
"According to clinicaltrials.gov, this particular medical trial is no longer accruing participants; the original posting was on January 1st 2023 and it has been updated as recently of October 19th 2022. However, there are currently 1391 other trials which are still in need of volunteers."
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