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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month follow up for reporting.

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 more

Awards & 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.

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