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Diabetes Disparities: Texting to Extend Treatment (DD-TXT)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention 1- DD-TXT
Comparison - DSE
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring text messaging, Health Equity, Health Care Quality, Access, and Evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans
  • active VHA patients with type 2 diabetes
  • have 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 Aim 1 DD-TXT development
  • must have access to their own or a cohabiting family member's cell phone or smartphone for participation. --must be willing and able to text, not have any visual impairment that would prevent them from reading or replying to text messages, and must be cognitively capable of consent to participate.
  • must also have HbA1c lab data (2+ values) for the 12 months prior to RCT recruitment.
  • must have inadequate glycemic control for at least 50% of the 6 months before enrollment.

Exclusion Criteria:

-Non-Veterans

Sites / Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FL
  • Jesse Brown VA Medical Center, Chicago, IL
  • VA Bedford HealthCare System, Bedford, MARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DD-TXT

DSE

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HbA1c percent time in control
The investigators will examine the changes in HbA1c percent time in control. These data will be calculated using HbA1c measures pulled from the electronic medical record data.

Secondary Outcome Measures

self-reported adherence to diabetes self-care recommendations (SCI-R)
Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R). These will be collected from the patient via a questionnaire conducted over the phone.
LDL
Secondary outcomes include LDL. These data will be pulled from the electronic medical record data.
self-reported diabetes self-efficacy
Secondary outcomes include self-reported adherence to diabetes self-efficacy. These will be collected from the patient via a questionnaire conducted over the phone.
self-reported diabetes distress
Secondary outcomes include self-reported diabetes distress. These will be collected from the patient via a questionnaire conducted over the phone.
blood pressure control
Secondary outcomes include blood pressure control. These data will be pulled from the electronic medical record data.

Full Information

First Posted
January 6, 2020
Last Updated
February 1, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04227379
Brief Title
Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
Official Title
Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 DD-TXT, 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", a new VA texting system for self-management support. Patients will be randomized to receive DD-TXT or an education-only texting intervention called DSE that is based on a diabetes skills workbook in order to test the comparative effectiveness of DD-TXT.
Detailed Description
Type 2 Diabetes is a common, complex health condition which can result in many serious and costly health complications if not treated and controlled properly. One in four Veterans are diagnosed with Type 2 Diabetes. Vulnerable Veterans, such as minority, low-income, or rural Veterans, and Veterans with comorbid mental health diagnoses, are disproportionately affected and are less likely to have their diabetes under control. The goal of this study, using a randomized comparative effectiveness design, is to test the comparative effectiveness of an interactive, tailored self-management texting protocol (DD-TXT), versus a traditional education-only intervention (DSE) in a sample of Veterans with uncontrolled diabetes. The investigators will recruit from Veterans age 18 years and above who are actively receiving care at the study sites (as determined by upcoming scheduled appointment) who have uncontrolled glucose (HbA1c >= 8.0% for at least 50% of the most recent 6 months). Participants who meet these conditions and enroll in the study will be randomized to one of two groups. Those randomized to the intervention group will receive text messages from the DD-TXT protocol for 6 months, and those in the comparison group will receive text messages from DSE, a diabetes skills education-only texting protocol, for 6 months. The primary outcome will be HbA1c percent time in control. Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R), diabetes self-efficacy, diabetes distress, LDL, and blood pressure control. The investigators hypothesize that DD-TXT will result in better proximal health outcomes and diabetes self-management behaviors vs an education-only protocol (DSE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
text messaging, Health Equity, Health Care Quality, Access, and Evaluation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Once consented by project coordinators, patients will be asked to complete the baseline survey instruments. Participants will then be randomized with stratification by gender, using a separate randomization table per site. The investigators will first recruit women, with the goal of achieving 10-20% of the sample at each site. The investigators will then recruit male Veterans until the investigators obtain 200 to DD-TXT and 200 to DSE, for a total of 400 enrolled across sites.
Masking
Participant
Masking Description
All participants will receive a texting intervention but they will not be told whether their intervention is part of the experimental or comparison arm.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DD-TXT
Arm Type
Experimental
Arm Description
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.
Arm Title
DSE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention 1- DD-TXT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Comparison - DSE
Intervention Description
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 workbook content but shortened to fit the 160-character limit of a text message (See Appendix 3 for sample messages from workbook). There will be no customizable or interactive content for the DSE arm.
Primary Outcome Measure Information:
Title
HbA1c percent time in control
Description
The investigators will examine the changes in HbA1c percent time in control. These data will be calculated using HbA1c measures pulled from the electronic medical record data.
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
self-reported adherence to diabetes self-care recommendations (SCI-R)
Description
Secondary outcomes include self-reported adherence to diabetes self-care recommendations (SCI-R). These will be collected from the patient via a questionnaire conducted over the phone.
Time Frame
6 month follow up
Title
LDL
Description
Secondary outcomes include LDL. These data will be pulled from the electronic medical record data.
Time Frame
6 month follow up
Title
self-reported diabetes self-efficacy
Description
Secondary outcomes include self-reported adherence to diabetes self-efficacy. These will be collected from the patient via a questionnaire conducted over the phone.
Time Frame
6 month follow up
Title
self-reported diabetes distress
Description
Secondary outcomes include self-reported diabetes distress. These will be collected from the patient via a questionnaire conducted over the phone.
Time Frame
6 month follow up
Title
blood pressure control
Description
Secondary outcomes include blood pressure control. These data will be pulled from the electronic medical record data.
Time Frame
6 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans active VHA patients with type 2 diabetes have 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 Aim 1 DD-TXT development must have access to their own or a cohabiting family member's cell phone or smartphone for participation. --must be willing and able to text, not have any visual impairment that would prevent them from reading or replying to text messages, and must be cognitively capable of consent to participate. must also have HbA1c lab data (2+ values) for the 12 months prior to RCT recruitment. must have inadequate glycemic control for at least 50% of the 6 months before enrollment. Exclusion Criteria: -Non-Veterans
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie L Shimada, PhD
Phone
(781) 687-2208
Email
Stephanie.Shimada@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy P Hogan, PhD MS BS
Phone
(781) 687-3181
Email
timothy.hogan@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie L Shimada, PhD
Organizational Affiliation
VA Bedford HealthCare System, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1135
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Enrolling by invitation
Facility Name
VA Bedford HealthCare System, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730-1114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John M Wells, PhD
Phone
781-687-2924
Email
John.Wells5@va.gov
First Name & Middle Initial & Last Name & Degree
Stephanie L Shimada, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes Disparities: Texting to Extend Treatment (DD-TXT)

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