NCT04227379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
3 years until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 1, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2.2 years

First QC Date

January 6, 2020

Results QC Date

May 1, 2026

Last Update Submit

June 1, 2026

Conditions

Diabetes Mellitus, Type 2

Keywords

text messagingHealth EquityHealth Care Quality, Access, and Evaluationself-management

Outcome Measures

Primary Outcomes (2)

  • Change in HbA1c Percent Time in Control

    The investigators examined the changes in HbA1c percent time in control. The cutoff for being in control was a HbA1c of 8.0 percent. Using HbA1c measures pulled from the electronic medical record data, we estimated the percentage of time HbA1c\<8.0% in the 6 month window prior to enrollment and during the 6 month trial. We then calculated the change in HbA1c percent time in control for each participant.

    pre-enrollment, 6 month follow up

  • Change in HbA1c

    We examined the changes in HbA1c. These data were calculated using HbA1c measures pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment HbA1c was measured by the closest HbA1c value before enrollment. The 6-month follow-up HbA1c was measured by the closest A1c to day 180 (6-months post-enrollment) available within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value.

    pre-enrollment, 6 month follow-up

Secondary Outcomes (13)

  • Change in LDL

    pre-enrollment, 6 month follow up

  • Change in Systolic Blood Pressure

    pre-enrollment, 6 month follow up

  • Change in Diastolic Blood Pressure

    pre-enrollment, 6 months

  • Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R)

    Baseline, 6 months

  • Change in Self-reported Diabetes Self-efficacy Scale (DSES)

    Baseline, 6 months

  • +8 more secondary outcomes

Study Arms (2)

DSMS+ (DSMS Plus)

EXPERIMENTAL

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.

Behavioral: Intervention 1- DSMS+

DSMS

ACTIVE COMPARATOR

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.

Behavioral: Comparison - DSMS

Interventions

Comparison - DSMSBEHAVIORAL

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.

Also known as: DSE
DSMS
Intervention 1- DSMS+BEHAVIORAL

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 th

Also known as: DD-TXT
DSMS+ (DSMS Plus)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 texting intervention 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (4)

  • Weinger K, Butler HA, Welch GW, La Greca AM. Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes Care. 2005 Jun;28(6):1346-52. doi: 10.2337/diacare.28.6.1346.

    PMID: 15920050BACKGROUND

  • Ritter PL, Lorig K, Laurent DD. Characteristics of the Spanish- and English-Language Self-Efficacy to Manage Diabetes Scales. Diabetes Educ. 2016 Apr;42(2):167-77. doi: 10.1177/0145721716628648. Epub 2016 Feb 4.

    PMID: 26846336BACKGROUND

  • Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.

    PMID: 18474888BACKGROUND

  • Mayberry LS, Gonzalez JS, Wallston KA, Kripalani S, Osborn CY. The ARMS-D out performs the SDSCA, but both are reliable, valid, and predict glycemic control. Diabetes Res Clin Pract. 2013 Nov;102(2):96-104. doi: 10.1016/j.diabres.2013.09.010. Epub 2013 Sep 26.

    PMID: 24209600BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Stephanie Shimada, PhD
Organization
Center for Health Optimization and Implementation Research (CHOIR), VA Bedford Healthcare System
stephanie.shimada@va.gov
781-687-2208

Study Officials

  • Stephanie L Shimada, PhD

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All participants received a diabetes self-management support texting intervention but they were not explicitly told whether their intervention was part of the experimental (DSMS+) or comparison (DSMS) arm.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 13, 2020

Study Start

January 30, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 26, 2026

Results First Posted

June 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)