Trial Outcomes & Findings for Diabetes Disparities: Texting to Extend Treatment (DD-TXT) (NCT NCT04227379)
NCT ID: NCT04227379
Last Updated: 2026-06-01
Results Overview
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.
COMPLETED
NA
366 participants
pre-enrollment, 6 month follow up
2026-06-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
186
|
180
|
|
Overall Study
Completed Follow-Up (6-month) Survey
|
169
|
167
|
|
Overall Study
Completed Follow-Up Interview
|
164
|
165
|
|
Overall Study
HbA1c Results After Enrollment Available to Calculate Primary Outcome
|
182
|
177
|
|
Overall Study
COMPLETED
|
182
|
177
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diabetes Disparities: Texting to Extend Treatment (DD-TXT)
Baseline characteristics by cohort
| Measure |
DSMS
n=186 Participants
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.
|
DSMS+ (DSMS Plus)
n=180 Participants
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.
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to 44
|
10 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
16 Participants
n=48 Participants
|
|
Age, Customized
45 to 64
|
96 Participants
n=24 Participants
|
93 Participants
n=24 Participants
|
189 Participants
n=48 Participants
|
|
Age, Customized
65+
|
80 Participants
n=24 Participants
|
81 Participants
n=24 Participants
|
161 Participants
n=48 Participants
|
|
Sex/Gender, Customized
Female
|
60 Participants
n=24 Participants
|
57 Participants
n=24 Participants
|
117 Participants
n=48 Participants
|
|
Sex/Gender, Customized
Male
|
125 Participants
n=24 Participants
|
123 Participants
n=24 Participants
|
248 Participants
n=48 Participants
|
|
Sex/Gender, Customized
Other
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=24 Participants
|
72 Participants
n=24 Participants
|
143 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Black
|
94 Participants
n=24 Participants
|
89 Participants
n=24 Participants
|
183 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
3 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
11 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
16 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=24 Participants
|
9 Participants
n=24 Participants
|
14 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
30 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
172 Participants
n=24 Participants
|
163 Participants
n=24 Participants
|
335 Participants
n=48 Participants
|
|
Race/Ethnicity, Customized
Prefer Not to Answer
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Rurality
Rural
|
32 Participants
n=24 Participants
|
35 Participants
n=24 Participants
|
67 Participants
n=48 Participants
|
|
Rurality
Urban
|
154 Participants
n=24 Participants
|
145 Participants
n=24 Participants
|
299 Participants
n=48 Participants
|
|
Relationship Status
In a relationship
|
99 Participants
n=24 Participants
|
90 Participants
n=24 Participants
|
189 Participants
n=48 Participants
|
|
Relationship Status
Not in a relationship
|
83 Participants
n=24 Participants
|
88 Participants
n=24 Participants
|
171 Participants
n=48 Participants
|
|
Relationship Status
Missing
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Relationship Status
Prefer Not to Answer
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=48 Participants
|
|
Education
Some High School
|
7 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
12 Participants
n=48 Participants
|
|
Education
High School Graduate
|
31 Participants
n=24 Participants
|
29 Participants
n=24 Participants
|
60 Participants
n=48 Participants
|
|
Education
Some college or vocational school
|
63 Participants
n=24 Participants
|
76 Participants
n=24 Participants
|
139 Participants
n=48 Participants
|
|
Education
Associate's degree
|
23 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
39 Participants
n=48 Participants
|
|
Education
Bachelor's degree
|
38 Participants
n=24 Participants
|
36 Participants
n=24 Participants
|
74 Participants
n=48 Participants
|
|
Education
Master's degree
|
17 Participants
n=24 Participants
|
16 Participants
n=24 Participants
|
33 Participants
n=48 Participants
|
|
Education
Doctoral Degree
|
4 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=48 Participants
|
|
Education
Prefer Not to Answer
|
3 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=48 Participants
|
|
Employment Status
Employed
|
58 Participants
n=24 Participants
|
54 Participants
n=24 Participants
|
112 Participants
n=48 Participants
|
|
Employment Status
Unemployed
|
21 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
34 Participants
n=48 Participants
|
|
Employment Status
Retired
|
71 Participants
n=24 Participants
|
74 Participants
n=24 Participants
|
145 Participants
n=48 Participants
|
|
Employment Status
Disabled/Unable to work
|
35 Participants
n=24 Participants
|
38 Participants
n=24 Participants
|
73 Participants
n=48 Participants
|
|
Employment Status
Prefer Not to Answer
|
1 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=48 Participants
|
|
Annual Income
Less than $10,000
|
9 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
15 Participants
n=48 Participants
|
|
Annual Income
$10,000 to $19,999
|
15 Participants
n=24 Participants
|
23 Participants
n=24 Participants
|
38 Participants
n=48 Participants
|
|
Annual Income
$20,000 to $29,999
|
19 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
31 Participants
n=48 Participants
|
|
Annual Income
$30,000 to $39,999
|
25 Participants
n=24 Participants
|
22 Participants
n=24 Participants
|
47 Participants
n=48 Participants
|
|
Annual Income
$40,000 to $49,999
|
23 Participants
n=24 Participants
|
29 Participants
n=24 Participants
|
52 Participants
n=48 Participants
|
|
Annual Income
$50,000 to $59,999
|
21 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
42 Participants
n=48 Participants
|
|
Annual Income
$60,000 to $69,999
|
30 Participants
n=24 Participants
|
21 Participants
n=24 Participants
|
51 Participants
n=48 Participants
|
|
Annual Income
$70,000 to $79,999
|
8 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=48 Participants
|
|
Annual Income
$80,000 to $89,999
|
8 Participants
n=24 Participants
|
14 Participants
n=24 Participants
|
22 Participants
n=48 Participants
|
|
Annual Income
$90,000 to $99,999
|
8 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
16 Participants
n=48 Participants
|
|
Annual Income
$100,000 to $149,999
|
15 Participants
n=24 Participants
|
13 Participants
n=24 Participants
|
28 Participants
n=48 Participants
|
|
Annual Income
$150,000 or more
|
4 Participants
n=24 Participants
|
5 Participants
n=24 Participants
|
9 Participants
n=48 Participants
|
|
Annual Income
Prefer Not to Answer
|
1 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=48 Participants
|
|
Housing
Own home/apt
|
159 Participants
n=24 Participants
|
150 Participants
n=24 Participants
|
309 Participants
n=48 Participants
|
|
Housing
Home of a family member or friend
|
7 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
19 Participants
n=48 Participants
|
|
Housing
Other
|
12 Participants
n=24 Participants
|
11 Participants
n=24 Participants
|
23 Participants
n=48 Participants
|
|
Housing
Missing
|
5 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
9 Participants
n=48 Participants
|
|
Housing
Prefer Not to Answer
|
3 Participants
n=24 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: pre-enrollment, 6 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=182 Participants
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.
|
DSMS+ (DSMS Plus)
n=177 Participants
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.
|
|---|---|---|
|
Change in HbA1c Percent Time in Control
|
23.41 percent (%) of time in control
Standard Deviation 34.96
|
21.61 percent (%) of time in control
Standard Deviation 40.55
|
PRIMARY outcome
Timeframe: pre-enrollment, 6 month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=158 Participants
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.
|
DSMS+ (DSMS Plus)
n=157 Participants
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.
|
|---|---|---|
|
Change in HbA1c
|
-0.36 Percentage of glycosylated hemoglobin
Standard Deviation 1.37
|
-0.40 Percentage of glycosylated hemoglobin
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: pre-enrollment, 6 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=82 Participants
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.
|
DSMS+ (DSMS Plus)
n=89 Participants
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.
|
|---|---|---|
|
Change in LDL
|
2.88 mg/dL
Standard Deviation 34.74
|
-7.68 mg/dL
Standard Deviation 30.28
|
SECONDARY outcome
Timeframe: pre-enrollment, 6 month follow upPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=159 Participants
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.
|
DSMS+ (DSMS Plus)
n=153 Participants
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.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-2.62 mmHg
Standard Deviation 12.48
|
-2.29 mmHg
Standard Deviation 12.68
|
SECONDARY outcome
Timeframe: pre-enrollment, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=159 Participants
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.
|
DSMS+ (DSMS Plus)
n=153 Participants
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.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-0.77 mmHg
Standard Deviation 7.09
|
-0.65 mmHg
Standard Deviation 5.83
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=162 Participants
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.
|
DSMS+ (DSMS Plus)
n=154 Participants
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.
|
|---|---|---|
|
Change in Self-reported Adherence to Diabetes Self-care Recommendations (SCI-R)
|
6.57 Score on a Scale
Standard Deviation 13.22
|
5.23 Score on a Scale
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=156 Participants
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.
|
DSMS+ (DSMS Plus)
n=158 Participants
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.
|
|---|---|---|
|
Change in Self-reported Diabetes Self-efficacy Scale (DSES)
|
.03 Score on a Scale
Standard Deviation 1.85
|
.41 Score on a Scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=146 Participants
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.
|
DSMS+ (DSMS Plus)
n=129 Participants
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.
|
|---|---|---|
|
Change in Self-reported Diabetes Distress Scale (DDS17)
|
-.13 Score on a Scale
Standard Deviation .94
|
-.32 Score on a Scale
Standard Deviation .95
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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 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.
Outcome measures
| Measure |
DSMS
n=160 Participants
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.
|
DSMS+ (DSMS Plus)
n=149 Participants
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.
|
|---|---|---|
|
Change in Self-reported DDS17 Emotional Burden Subscale
|
-.14 Score on a Scale
Standard Deviation 1.28
|
-.45 Score on a Scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=161 Participants
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.
|
DSMS+ (DSMS Plus)
n=149 Participants
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.
|
|---|---|---|
|
Change in Self-reported DDS17 Physician-related Distress Subscale
|
-.13 Score on a Scale
Standard Deviation 1.07
|
-.20 Score on a Scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=155 Participants
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.
|
DSMS+ (DSMS Plus)
n=149 Participants
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.
|
|---|---|---|
|
Change in Self-reported DDS17 Regimen-Related Distress Subscale
|
-.23 Score on a Scale
Standard Deviation 1.16
|
-.55 Score on a Scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=162 Participants
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.
|
DSMS+ (DSMS Plus)
n=159 Participants
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.
|
|---|---|---|
|
Change in Self-reported DDS17 Interpersonal Distress Subscale
|
.08 Score on a Scale
Standard Deviation 1.15
|
-.18 Score on a Scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=145 Participants
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.
|
DSMS+ (DSMS Plus)
n=145 Participants
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.
|
|---|---|---|
|
Change in Self-reported Adherence to Refills and Medications Scale for Diabetes (ARMS-D)
|
-1.20 Score on a Scale
Standard Deviation 3.25
|
-.67 Score on a Scale
Standard Deviation 3.41
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=168 Participants
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.
|
DSMS+ (DSMS Plus)
n=166 Participants
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.
|
|---|---|---|
|
Change in Self-reported Physical Health Summary Score
|
.79 Score on a Scale
Standard Deviation 8.78
|
1.09 Score on a Scale
Standard Deviation 8.34
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
DSMS
n=168 Participants
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.
|
DSMS+ (DSMS Plus)
n=166 Participants
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.
|
|---|---|---|
|
Change in Self-reported Mental Health Summary Score
|
-0.02 Score on a Scale
Standard Deviation 11.10
|
1.02 Score on a Scale
Standard Deviation 9.70
|
Adverse Events
DSMS
DSMS+ (DSMS Plus)
Serious adverse events
| Measure |
DSMS
n=186 participants at risk
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.
|
DSMS+ (DSMS Plus)
n=180 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/186 • 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.
|
0.56%
1/180 • 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.
|
|
Reproductive system and breast disorders
Hospitalization of participant
|
0.00%
0/186 • 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.
|
0.56%
1/180 • 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.
|
|
Vascular disorders
Intracerebral hemorrhage
|
0.54%
1/186 • 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.
|
0.00%
0/180 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Stephanie Shimada, PhD
Center for Health Optimization and Implementation Research (CHOIR), VA Bedford Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place