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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.
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, was to test the comparative effectiveness of an interactive, customizable diabetes self-management support texting protocol (DSMS+), versus a standardized education-only intervention (DSMS) in a sample of Veterans with uncontrolled diabetes.
The team will invited Veterans age 18 years and above who were actively receiving care at the study sites (as determined by upcoming scheduled appointment) who had uncontrolled glucose (HbA1c >= 8.0% for at least 50% of the most recent 6 months). Participants who met these conditions and enrolled in the study were randomized to one of two study arms: DSMS or DSMS+. Both arms received text-based diabetes self-management support for 6 months. The primary outcome was 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 team hypothesized that the customizable texting intervention (DSMS+) would result in better proximal health outcomes and diabetes self-management behaviors vs a standardized, education-only protocol (DSMS).
Please note that we previously referred to DSMS as DSE (diabetes standardized education) and DSMS+ as DD-TXT (Diabetes Disparities: Texting to Extend Treatment) after the trial name. We updated the names to better clarify that both are diabetes self-management support texting interventions, with DSMS+ having additional, customizable and interactive content that patients can choose from.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL | We examined the changes in LDL. These data were calculated using LDL measures pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment HbA1c was measured by the mean LDL value in the 6 months prior to enrollment. The 6-month follow-up LDL was measured by the mean of any LDL values 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie L Shimada, PhD | VA Bedford HealthCare System, Bedford, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida | 32608-1135 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15920050 | Background | 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. | |
| 26846336 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSMS | Participants in this arm 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. 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. In preparation for this trial, we developed DSMS text messages based on trusted educational content (the VA educational workbook entitled "Self-Care Skills for the Person with Diabetes", created in alignment with VA/DoD diabetes guidelines, the ADCES7 Self-Care Behaviors, and other trusted DSMES resources) and incorporated Veteran input through a co-design process with Veterans living with diabetes followed by expert clinician review of messages. The same DSMS text messages were used in both arms. |
| FG001 | DSMS+ (DSMS Plus) | Participants in this arm 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 (Vet Tips), 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. In preparation for this trial, we developed DSMS text messages based on trusted educational content (a VA diabetes education content created in alignment with VA/DoD diabetes guidelines, the ADCES7 Self-Care Behaviors, and other trusted DSMES resources) and incorporated Veteran input through a co-design process with Veterans living with diabetes followed by expert clinician review of messages. The same DSMS text messages were used in both arms. The additional modules in this arm were similarly refined or developed via co-design with Veteran input and expert clinician review. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DSMS | Participants in this arm 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We included all participants for whom there was the necessary HBA1c data in both the pre-enrollment window, during, and after enrollment. There were seven participants who did not have follow-up lab HBA1c testing so could not be included in the number of participants analyzed, four in DSMS group and 3 in the DSMS+ group. | Posted | Mean | Standard Deviation | percent (%) of time in control | pre-enrollment, 6 month follow up |
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From enrollment until end of follow-up, up to 210 days post-enrollment.
A tracking sheet to track any adverse and serious adverse events (AEs) was created. AEs were identified when checking the Electronic Health Record prior to outreach (e.g., to schedule follow-up interview) or when participants informed us of a hospitalization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DSMS | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | Patient death from myocardial infarction noted in EHR was discovered by study coordinator when preparing to schedule follow-up interview. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Shimada, PhD | Center for Health Optimization and Implementation Research (CHOIR), VA Bedford Healthcare System | 781-687-2208 | stephanie.shimada@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2024 | May 1, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2024 | Oct 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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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.
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| Comparison - DSMS | Behavioral | 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. |
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| pre-enrollment, 6 month follow up |
| Change in Systolic Blood Pressure | We examined the changes in systolic blood pressure (SBP). These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment SBP was measured by the mean SBP in the year (365 days) prior to enrollment. The 6-month follow-up SBP was measured by the mean SBP taken 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 |
| Change in Diastolic Blood Pressure | We examined the changes in diastolic blood pressure (DBP). These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment DBP was measured by the mean DBP in the year (365 days) prior to enrollment. The 6-month follow-up DBP was measured by the mean DBP taken 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 months |
| Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R) | Secondary outcomes included self-reported adherence to diabetes self-care recommendations (SCI-R). We administered the SCI-R to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by averaging the 12 items relevant to type 2 diabetes, each item scored 1(Never) to 5(Always), and converting to a 0-100 scale. A higher score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported Diabetes Self-efficacy Scale (DSES) | We measured diabetes self-efficacy using the Diabetes Self-Efficacy Scale (DSES). We administered the DSES to participants via an online survey at enrollment and again at 6-month follow-up. The score was calculated by the average of 8 items, each item 1(Not at all Confident) to 10(Totally Confident), with a theoretical scale of 1 to 10, and a higher score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported Diabetes Distress Scale (DDS17) | Secondary outcomes included self-reported diabetes distress measured by the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 17 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the change between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported DDS17 Emotional Burden Subscale | The DDS17 Emotional Burden Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported DDS17 Physician-related Distress Subscale | The DDS17 Physician-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 4 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported DDS17 Regimen-Related Distress Subscale | The DDS17 Regimen-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported DDS17 Interpersonal Distress Subscale | The DDS17 Interpersonal Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 3 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | We measured self-reported adherence to diabetes medications using the ARMS-D. We administered the ARMS-D to participants via an online survey at enrollment and again at 6-month follow-up. The score was calculated by the sum of 11 items, each item 1(None of the time) to 4(All of the time), with a theoretical score range of 11 to 44, and a lower score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported Physical Health Summary Score | Secondary outcomes included self-reported physical health. This was collected from the patient via a questionnaire conducted over the phone. The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey (VR-12) into a theoretical scale of 0-100 points, and a higher score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Change in Self-reported Mental Health Summary Score | Secondary outcomes included self-reported mental health. This was collected from the patient via a questionnaire conducted over the phone. The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey into a theoretical scale of 0-100 points, and a higher score was better. We calculated the difference between the follow-up score and baseline. | Baseline, 6 months |
| Jesse Brown VA Medical Center, Chicago, IL |
| Chicago |
| Illinois |
| 60612 |
| United States |
| VA Bedford HealthCare System, Bedford, MA | Bedford | Massachusetts | 01730-1114 | United States |
| 18474888 | Background | 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. |
| 24209600 | Background | 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. |
| BG001 | DSMS+ (DSMS Plus) | Participants in this arm 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Rurality | Count of Participants | Participants |
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| Relationship Status | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Annual Income | Count of Participants | Participants |
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| Housing | Count of Participants | Participants |
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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.
| OG001 | DSMS+ (DSMS Plus) | 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. |
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| Primary | 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. | We included all participants for whom there was the necessary HBA1c data in both the pre-enrollment window and after trial enrollment (between days 91-271 post-enrollment). There were 51 participants not included in the analysis, 28 participants in DSMS group and 23 in the DSMS+ group, as they did not have follow-up lab HBA1c testing. | Posted | Mean | Standard Deviation | Percentage of glycosylated hemoglobin | pre-enrollment, 6 month follow-up |
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| Secondary | Change in LDL | We examined the changes in LDL. These data were calculated using LDL measures pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment HbA1c was measured by the mean LDL value in the 6 months prior to enrollment. The 6-month follow-up LDL was measured by the mean of any LDL values 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. | We included participants for whom there was the necessary LDL data in both the pre-enrollment window (6 months prior to enrollment) and post-enrollment (days 91-271 post-enrollment). There were 195 people not included in the analysis, 104 from the DSMS arm and 91 people from the DSMS+ arm. | Posted | Mean | Standard Deviation | mg/dL | pre-enrollment, 6 month follow up |
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| Secondary | Change in Systolic Blood Pressure | We examined the changes in systolic blood pressure (SBP). These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment SBP was measured by the mean SBP in the year (365 days) prior to enrollment. The 6-month follow-up SBP was measured by the mean SBP taken within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value. | We included all participants for whom there was the systolic blood pressure at both the baseline (1 - 365 days before enrollment) and follow-up (91-271 days after enrollment) timepoints. There were 54 people not included in the analysis, 27 from the DSMS arm and 27 from the DSMS+ arm. | Posted | Mean | Standard Deviation | mmHg | pre-enrollment, 6 month follow up |
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| Secondary | Change in Diastolic Blood Pressure | We examined the changes in diastolic blood pressure (DBP). These data were calculated using blood pressure readings pulled from the electronic medical record data prior to and after trial enrollment. The pre-enrollment DBP was measured by the mean DBP in the year (365 days) prior to enrollment. The 6-month follow-up DBP was measured by the mean DBP taken within the window of 91-271 days post-enrollment. The change was calculated by subtracting the pre-enrollment value from the 6-month value. | We included all participants for whom there was the diastolic blood pressure at both the baseline (1-365 days prior to enrollment) and follow-up (91-271 days post-enrollment) timepoints. There were 54 people not included in the analysis, 27 from the DSMS arm and 27 from the DSMS+ arm. | Posted | Mean | Standard Deviation | mmHg | pre-enrollment, 6 months |
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| Secondary | Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R) | Secondary outcomes included self-reported adherence to diabetes self-care recommendations (SCI-R). We administered the SCI-R to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by averaging the 12 items relevant to type 2 diabetes, each item scored 1(Never) to 5(Always), and converting to a 0-100 scale. A higher score was better. We calculated the difference between the follow-up score and baseline. | We included all participants for whom we could calculate valid SCI-R scores for both the baseline survey and the follow-up 6-month survey. There were 50 people not included in the analysis, 24 in the DSMS arm and 26 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported Diabetes Self-efficacy Scale (DSES) | We measured diabetes self-efficacy using the Diabetes Self-Efficacy Scale (DSES). We administered the DSES to participants via an online survey at enrollment and again at 6-month follow-up. The score was calculated by the average of 8 items, each item 1(Not at all Confident) to 10(Totally Confident), with a theoretical scale of 1 to 10, and a higher score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 52 people not included in the analysis, 30 in the DSMS arm and 22 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported Diabetes Distress Scale (DDS17) | Secondary outcomes included self-reported diabetes distress measured by the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 17 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the change between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes (i.e., responded to all 17 items on both surveys) in order to obtain a change score. There were 91 people not included in the analysis, 40 in the DSMS arm and 51 in the DSMS+ arm due to one or more of the 17 items missing a response. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported DDS17 Emotional Burden Subscale | The DDS17 Emotional Burden Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 57 people not included in the analysis, 26 in the DSMS arm and 31 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported DDS17 Physician-related Distress Subscale | The DDS17 Physician-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 4 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 56 people not included in the analysis, 25 in the DSMS arm and 31 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported DDS17 Regimen-Related Distress Subscale | The DDS17 Regimen-Related Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 5 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 62 people not included in the analysis, 31 in the DSMS arm and 31 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported DDS17 Interpersonal Distress Subscale | The DDS17 Interpersonal Distress Subscale is a subscale of the Diabetes Distress Scale (DDS17). We administered the DDS17 to participants via an online survey at enrollment and again at the 6-month follow-up. The score was calculated by the average of 3 items, each item 1(Not a problem) to 6(Very Serious Problem), with a theoretical score range of 1 to 6, and a lower score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 45 people not included in the analysis, 24 in the DSMS arm and 21 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | We measured self-reported adherence to diabetes medications using the ARMS-D. We administered the ARMS-D to participants via an online survey at enrollment and again at 6-month follow-up. The score was calculated by the sum of 11 items, each item 1(None of the time) to 4(All of the time), with a theoretical score range of 11 to 44, and a lower score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 76 people not included in the analysis, 41 in the DSMS arm and 35 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported Physical Health Summary Score | Secondary outcomes included self-reported physical health. This was collected from the patient via a questionnaire conducted over the phone. The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey (VR-12) into a theoretical scale of 0-100 points, and a higher score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 32 people not included in the analysis, 18 in the DSMS arm and 14 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| Secondary | Change in Self-reported Mental Health Summary Score | Secondary outcomes included self-reported mental health. This was collected from the patient via a questionnaire conducted over the phone. The score was calculated through an algorithm that transforms the 12 items from the Veterans RAND 12 Item Health Survey into a theoretical scale of 0-100 points, and a higher score was better. We calculated the difference between the follow-up score and baseline. | We included all participants who completed both the baseline survey and the follow-up 6-month survey who for whom we could compute the measure at both timeframes in order to obtain a change score. There were 32 people not included in the analysis, 18 in the DSMS arm and 14 in the DSMS+ arm. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, 6 months |
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| 1 |
| 186 |
| 1 |
| 186 |
| 0 |
| 186 |
| EG001 | DSMS+ (DSMS Plus) | 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. | 1 | 180 | 2 | 180 | 0 | 180 |
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| Hospitalization of participant | Reproductive system and breast disorders | Non-systematic Assessment | Patient contacted us about a hospitalization to undergo surgery for cancer |
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| Intracerebral hemorrhage | Vascular disorders | Non-systematic Assessment | Patient death post-hospitalization for intracerebral hemorrhage noted in EHR was discovered by study coordinator when preparing to schedule follow-up interview. |
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Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |