Diabetes Mellitus, Type 2
Conditions
Keywords
text messaging, Health Equity, Health Care Quality, Access, and Evaluation, self-management
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.
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, 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.
Interventions
BEHAVIORALIntervention 1- DSMS+
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
BEHAVIORALComparison - 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c Percent Time in Control | pre-enrollment, 6 month follow up | 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. |
| Change in HbA1c | pre-enrollment, 6 month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL | pre-enrollment, 6 month follow up | 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. |
| Change in Systolic Blood Pressure | pre-enrollment, 6 month follow up | 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. |
| Change in Diastolic Blood Pressure | pre-enrollment, 6 months | 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. |
| Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R) | Baseline, 6 months | 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. |
| Change in Self-reported Diabetes Self-efficacy Scale (DSES) | Baseline, 6 months | 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. |
| Change in Self-reported Diabetes Distress Scale (DDS17) | Baseline, 6 months | 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. |
| Change in Self-reported DDS17 Emotional Burden Subscale | Baseline, 6 months | 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. |
| Change in Self-reported DDS17 Physician-related Distress Subscale | Baseline, 6 months | 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. |
| Change in Self-reported DDS17 Regimen-Related Distress Subscale | Baseline, 6 months | 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. |
| Change in Self-reported DDS17 Interpersonal Distress Subscale | Baseline, 6 months | 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. |
| Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D) | Baseline, 6 months | 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. |
| Change in Self-reported Physical Health Summary Score | Baseline, 6 months | 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. |
| Change in Self-reported Mental Health Summary Score | Baseline, 6 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie L Shimada, PhD
VA Bedford HealthCare System, Bedford, MA
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18 to 44 | 16 Participants |
| Age, Customized 45 to 64 | 93 Participants |
| Age, Customized 65+ | 161 Participants |
| Annual Income $100,000 to $149,999 | 15 Participants |
| Annual Income $10,000 to $19,999 | 15 Participants |
| Annual Income $150,000 or more | 4 Participants |
| Annual Income $20,000 to $29,999 | 12 Participants |
| Annual Income $30,000 to $39,999 | 22 Participants |
| Annual Income $40,000 to $49,999 | 29 Participants |
| Annual Income $50,000 to $59,999 | 21 Participants |
| Annual Income $60,000 to $69,999 | 30 Participants |
| Annual Income $70,000 to $79,999 | 8 Participants |
| Annual Income $80,000 to $89,999 | 8 Participants |
| Annual Income $90,000 to $99,999 | 16 Participants |
| Annual Income Less than $10,000 | 15 Participants |
| Annual Income Prefer Not to Answer | 1 Participants |
| Education Associate's degree | 16 Participants |
| Education Bachelor's degree | 38 Participants |
| Education Doctoral Degree | 5 Participants |
| Education High School Graduate | 29 Participants |
| Education Master's degree | 16 Participants |
| Education Prefer Not to Answer | 1 Participants |
| Education Some college or vocational school | 63 Participants |
| Education Some High School | 12 Participants |
| Employment Status Disabled/Unable to work | 73 Participants |
| Employment Status Employed | 58 Participants |
| Employment Status Prefer Not to Answer | 2 Participants |
| Employment Status Retired | 74 Participants |
| Employment Status Unemployed | 13 Participants |
| Housing Home of a family member or friend | 19 Participants |
| Housing Missing | 5 Participants |
| Housing Other | 23 Participants |
| Housing Own home/apt | 150 Participants |
| Housing Prefer Not to Answer | 3 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 89 Participants |
| Race/Ethnicity, Customized Hispanic | 17 Participants |
| Race/Ethnicity, Customized Multi-racial | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 172 Participants |
| Race/Ethnicity, Customized Other | 9 Participants |
| Race/Ethnicity, Customized Prefer Not to Answer | 1 Participants |
| Race/Ethnicity, Customized White | 72 Participants |
| Relationship Status In a relationship | 189 Participants |
| Relationship Status Missing | 1 Participants |
| Relationship Status Not in a relationship | 83 Participants |
| Relationship Status Prefer Not to Answer | 3 Participants |
| Rurality Rural | 35 Participants |
| Rurality Urban | 154 Participants |
| Sex/Gender, Customized Female | 117 Participants |
| Sex/Gender, Customized Male | 248 Participants |
| Sex/Gender, Customized Other | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 186 | 1 / 180 |
| other Total, other adverse events | 0 / 186 | 0 / 180 |
| serious Total, serious adverse events | 1 / 186 | 2 / 180 |
Outcome results
None listed