Trial Outcomes & Findings for Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes (NCT NCT02409329)
NCT ID: NCT02409329
Last Updated: 2020-08-17
Results Overview
as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
512 participants
Primary outcome timeframe
Baseline, 3 months, 6 months, 12 months, 15 months
Results posted on
2020-08-17
Participant Flow
6 participants were administratively withdrawn prior to randomization; 5 were unreachable during a pre-determined run-in period after enrollment, 1 behaved inappropriately with a research assistant during enrollment
Participant milestones
| Measure |
REACH
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
REACH + FAMS
In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After 6 months, participants in this arm will receive REACH text messages only.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
REACH + FAMS: The intervention consists of REACH individually-focused text mes
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
127
|
126
|
253
|
|
Overall Study
COMPLETED
|
122
|
120
|
244
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
REACH
n=127 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
REACH + FAMS
n=126 Participants
In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for 6 months. After six months, participants in this arm will receive REACH text messages only.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
REACH + FAMS: The intervention consists of REACH individually-focused text mes
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Total
n=506 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
109 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
412 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
56.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
451 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
255 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
126 participants
n=7 Participants
|
253 participants
n=5 Participants
|
506 participants
n=4 Participants
|
|
Hemoglobin A1c (%)
|
8.72 percent
STANDARD_DEVIATION 1.79 • n=5 Participants
|
8.56 percent
STANDARD_DEVIATION 1.90 • n=7 Participants
|
8.53 percent
STANDARD_DEVIATION 1.80 • n=5 Participants
|
8.58 percent
STANDARD_DEVIATION 1.82 • n=4 Participants
|
|
Medication Adherence - Summary of Diabetes Self-Care Activities medication subscale
|
6.25 days in a week
STANDARD_DEVIATION 1.37 • n=5 Participants
|
6.37 days in a week
STANDARD_DEVIATION 1.09 • n=7 Participants
|
6.41 days in a week
STANDARD_DEVIATION 1.16 • n=5 Participants
|
6.36 days in a week
STANDARD_DEVIATION 1.20 • n=4 Participants
|
|
Medication Adherence - Adherence to Refills and Medications Scale for Diabetes
|
39.90 score on a scale
STANDARD_DEVIATION 3.74 • n=5 Participants
|
39.66 score on a scale
STANDARD_DEVIATION 3.54 • n=7 Participants
|
40.21 score on a scale
STANDARD_DEVIATION 3.34 • n=5 Participants
|
39.99 score on a scale
STANDARD_DEVIATION 3.54 • n=4 Participants
|
|
Use of dietary information - Personal Diabetes Questionnaire
|
3.09 score on a scale
STANDARD_DEVIATION 1.74 • n=5 Participants
|
2.85 score on a scale
STANDARD_DEVIATION 1.57 • n=7 Participants
|
2.96 score on a scale
STANDARD_DEVIATION 1.70 • n=5 Participants
|
2.97 score on a scale
STANDARD_DEVIATION 1.68 • n=4 Participants
|
|
Problem eating behaviors - Personal Diabetes Questionnaire
|
3.23 score on a scale
STANDARD_DEVIATION 1.08 • n=5 Participants
|
3.43 score on a scale
STANDARD_DEVIATION 1.04 • n=7 Participants
|
3.35 score on a scale
STANDARD_DEVIATION 1.16 • n=5 Participants
|
3.34 score on a scale
STANDARD_DEVIATION 1.11 • n=4 Participants
|
|
MET-minutes per week - International Physical Activity Questionnaire-short form
|
2565.11 MET-minutes per week
STANDARD_DEVIATION 3108.48 • n=5 Participants
|
1836.23 MET-minutes per week
STANDARD_DEVIATION 2183.39 • n=7 Participants
|
2348.91 MET-minutes per week
STANDARD_DEVIATION 2853.58 • n=5 Participants
|
2274.58 MET-minutes per week
STANDARD_DEVIATION 2777.96 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
Outcome measures
| Measure |
REACH
n=253 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
3 months
|
8.29 percent
Standard Deviation 1.49
|
8.59 percent
Standard Deviation 1.65
|
—
|
|
Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
15 months
|
8.59 percent
Standard Deviation 1.81
|
8.61 percent
Standard Deviation 1.95
|
—
|
|
Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
6 months
|
8.32 percent
Standard Deviation 1.65
|
8.57 percent
Standard Deviation 2.15
|
—
|
|
Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
12 months
|
8.66 percent
Standard Deviation 1.97
|
8.70 percent
Standard Deviation 2.10
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence
Outcome measures
| Measure |
REACH
n=253 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Self-reported Medication Adherence
3 months
|
6.59 days per week
Standard Deviation 0.96
|
6.38 days per week
Standard Deviation 1.25
|
—
|
|
Change in Self-reported Medication Adherence
12 months
|
6.50 days per week
Standard Deviation 1.09
|
6.27 days per week
Standard Deviation 1.46
|
—
|
|
Change in Self-reported Medication Adherence
15 months
|
6.36 days per week
Standard Deviation 1.22
|
6.18 days per week
Standard Deviation 1.45
|
—
|
|
Change in Self-reported Medication Adherence
6 months
|
6.64 days per week
Standard Deviation 0.89
|
6.24 days per week
Standard Deviation 1.51
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44
Outcome measures
| Measure |
REACH
n=253 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Self-reported Medication Adherence
3 months
|
40.4 score on a scale
Standard Deviation 3.62
|
40.4 score on a scale
Standard Deviation 3.45
|
—
|
|
Change in Self-reported Medication Adherence
6 months
|
40.6 score on a scale
Standard Deviation 3.48
|
40.2 score on a scale
Standard Deviation 3.49
|
—
|
|
Change in Self-reported Medication Adherence
12 months
|
40.3 score on a scale
Standard Deviation 3.48
|
40.2 score on a scale
Standard Deviation 3.99
|
—
|
|
Change in Self-reported Medication Adherence
15 months
|
40.5 score on a scale
Standard Deviation 3.24
|
40.4 score on a scale
Standard Deviation 3.90
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)
Outcome measures
| Measure |
REACH
n=253 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Adherence to Dietary Behavior
3 months
|
3.17 score on a scale
Standard Deviation 1.59
|
2.84 score on a scale
Standard Deviation 1.58
|
—
|
|
Change in Adherence to Dietary Behavior
6 months
|
3.34 score on a scale
Standard Deviation 1.56
|
2.93 score on a scale
Standard Deviation 1.62
|
—
|
|
Change in Adherence to Dietary Behavior
12 months
|
3.22 score on a scale
Standard Deviation 1.58
|
2.88 score on a scale
Standard Deviation 1.61
|
—
|
|
Change in Adherence to Dietary Behavior
15 months
|
3.17 score on a scale
Standard Deviation 1.65
|
3.01 score on a scale
Standard Deviation 1.77
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)
Outcome measures
| Measure |
REACH
n=253 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Adherence to Dietary Behavior
3 months
|
3.17 score on a scale
Standard Deviation 1.03
|
3.28 score on a scale
Standard Deviation 1.13
|
—
|
|
Change in Adherence to Dietary Behavior
6 months
|
3.11 score on a scale
Standard Deviation 0.95
|
3.18 score on a scale
Standard Deviation 1.06
|
—
|
|
Change in Adherence to Dietary Behavior
12 months
|
3.09 score on a scale
Standard Deviation 1.07
|
3.13 score on a scale
Standard Deviation 1.09
|
—
|
|
Change in Adherence to Dietary Behavior
15 months
|
3.18 score on a scale
Standard Deviation 1.15
|
3.18 score on a scale
Standard Deviation 1.11
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention (combining REACH and REACH + FAMS) with participants not receiving REACH (in condition Helpline and A1c Results).
as measured by International Physical Activity Questionnaire-Short form \[metabolic equivalent minutes (MET-minutes) per week\] where more MET-minutes per week indicates more physical activity
Outcome measures
| Measure |
REACH
n=253 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=253 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Physical Activity
3 months
|
2285 MET-minutes per week
Standard Deviation 2973
|
2139 MET-minutes per week
Standard Deviation 2501
|
—
|
|
Change in Physical Activity
6 months
|
2332 MET-minutes per week
Standard Deviation 3168
|
1991 MET-minutes per week
Standard Deviation 2547
|
—
|
|
Change in Physical Activity
12 months
|
2573 MET-minutes per week
Standard Deviation 3329
|
2273 MET-minutes per week
Standard Deviation 2883
|
—
|
|
Change in Physical Activity
15 months
|
2221 MET-minutes per week
Standard Deviation 2973
|
2239 MET-minutes per week
Standard Deviation 2774
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 months, 6 months, 12 months, 15 monthsPopulation: We compared participants receiving the REACH intervention only with those receiving REACH + FAMS and with participants not receiving REACH (in condition Helpline and A1c Results). This analysis was subsetted to participants with baseline HbA1c greater than or equal to 8.5% with the goal of improved power.
as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.
Outcome measures
| Measure |
REACH
n=59 Participants
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months.
All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
REACH: The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=52 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
Helpline and A1c Results
n=106 Participants
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring).
All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions.
Helpline and A1c results: Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
|
|---|---|---|---|
|
Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
3 months
|
9.12 percent
Standard Deviation 1.41
|
8.98 percent
Standard Deviation 1.61
|
9.47 percent
Standard Deviation 1.77
|
|
Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
6 months
|
8.88 percent
Standard Deviation 1.64
|
9.14 percent
Standard Deviation 1.53
|
9.74 percent
Standard Deviation 2.37
|
|
Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
12 months
|
9.45 percent
Standard Deviation 1.89
|
9.57 percent
Standard Deviation 2.19
|
9.67 percent
Standard Deviation 2.21
|
|
Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
15 months
|
9.28 percent
Standard Deviation 1.97
|
9.41 percent
Standard Deviation 1.74
|
9.57 percent
Standard Deviation 2.25
|
Adverse Events
REACH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
REACH + FAMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Helpline and A1c Results
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lindsay S. Mayberry, PhD, MS
Vanderbilt University Medical Center
Phone: 615-875-5821
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place