Trial Outcomes & Findings for Regimen Education and Messaging in Diabetes (REMinD) (NCT NCT03185741)
NCT ID: NCT03185741
Last Updated: 2023-03-10
Results Overview
Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
767 participants
Primary outcome timeframe
6 months after baseline
Results posted on
2023-03-10
Participant Flow
Participant milestones
| Measure |
UMS Strategy
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
Patients of providers randomized to the usual care arm will receive their standard care
|
|---|---|---|---|
|
Baseline
STARTED
|
246
|
272
|
249
|
|
Baseline
COMPLETED
|
244
|
267
|
244
|
|
Baseline
NOT COMPLETED
|
2
|
5
|
5
|
|
3Month
STARTED
|
244
|
267
|
244
|
|
3Month
COMPLETED
|
224
|
242
|
219
|
|
3Month
NOT COMPLETED
|
20
|
25
|
25
|
|
6Month
STARTED
|
235
|
252
|
230
|
|
6Month
COMPLETED
|
216
|
233
|
211
|
|
6Month
NOT COMPLETED
|
19
|
19
|
19
|
Reasons for withdrawal
| Measure |
UMS Strategy
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
Patients of providers randomized to the usual care arm will receive their standard care
|
|---|---|---|---|
|
Baseline
Withdrawal by Subject
|
1
|
3
|
2
|
|
Baseline
Lost to Follow-up
|
1
|
2
|
3
|
|
3Month
Death
|
1
|
1
|
2
|
|
3Month
Withdrawal by Subject
|
1
|
5
|
1
|
|
3Month
Lost to Follow-up
|
7
|
9
|
8
|
|
3Month
Unavailable for 3Month
|
11
|
10
|
11
|
|
3Month
Protocol Violation
|
0
|
0
|
3
|
|
6Month
Death
|
1
|
1
|
2
|
|
6Month
Withdrawal by Subject
|
2
|
3
|
1
|
|
6Month
Lost to Follow-up
|
16
|
15
|
16
|
Baseline Characteristics
Regimen Education and Messaging in Diabetes (REMinD)
Baseline characteristics by cohort
| Measure |
UMS Strategy
n=244 Participants
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
n=265 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
n=241 Participants
Patients of providers randomized to the usual care arm will receive their standard care
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.12 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
61.82 years
STANDARD_DEVIATION 10.91 • n=7 Participants
|
60.60 years
STANDARD_DEVIATION 9.96 • n=5 Participants
|
61.20 years
STANDARD_DEVIATION 10.54 • n=4 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
445 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
305 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
105 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
108 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
364 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Recruitment Site
Northwestern
|
118 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Recruitment Site
Mount Sinai
|
126 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
358 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months after baselinePopulation: Observations were excluded if: 1.Medications were not in pill form; 2.Participants couldn't provide quantities on their bottles; 3.Missing Fill or Start Dates, 4.Participants started their medications on the same date as their pill count date; 5. Missing medications labels; 6. Participants combined medication bottles and discarded their old bottles; 7. Pills taken \> Quantity on bottle; 8. PRN Medications 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent.
Outcome measures
| Measure |
UMS Strategy
n=551 medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
n=725 medications
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
n=584 medications
Patients of providers randomized to the usual care arm will receive their standard care
|
|---|---|---|---|
|
Medication Adherence: Pill Count
|
0.28 Probability of adherence (PT/PP =>0.80)
Interval 0.24 to 0.33
|
0.29 Probability of adherence (PT/PP =>0.80)
Interval 0.25 to 0.34
|
0.30 Probability of adherence (PT/PP =>0.80)
Interval 0.25 to 0.36
|
SECONDARY outcome
Timeframe: 6 months after baselinePopulation: Observations were excluded if participants did not complete the 24-hour recall questions. 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
Adherence will be measured for each prescription medication using self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients are asked to specify the amount taken (i.e. dose) and when taken (to determine frequency and interval between doses). A patient is considered adherent on a specific medication if they answered all correctly: 1.dose, 2.frequency, 3.interval between doses
Outcome measures
| Measure |
UMS Strategy
n=1059 medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
n=1192 medications
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
n=1090 medications
Patients of providers randomized to the usual care arm will receive their standard care
|
|---|---|---|---|
|
Medication Adherence: 24-hour Recall
|
0.72 Probability of Adherence (Yes)
Interval 0.67 to 0.76
|
0.67 Probability of Adherence (Yes)
Interval 0.62 to 0.71
|
0.69 Probability of Adherence (Yes)
Interval 0.64 to 0.73
|
SECONDARY outcome
Timeframe: 6 months after baselinePopulation: Observations were excluded if participants did not complete the ASK12 survey 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence.
Outcome measures
| Measure |
UMS Strategy
n=216 Participants
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
n=231 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
n=208 Participants
Patients of providers randomized to the usual care arm will receive their standard care
|
|---|---|---|---|
|
Medication Adherence: ASK-12
|
23.0 score on a scale (12-60)
Interval 22.23 to 23.82
|
23.89 score on a scale (12-60)
Interval 23.12 to 24.66
|
23.22 score on a scale (12-60)
Interval 22.39 to 24.05
|
SECONDARY outcome
Timeframe: 6 months after baselinePopulation: Observations were excluded if participants did not answer the question. 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
Identification of drug purpose
Outcome measures
| Measure |
UMS Strategy
n=1013 Medications
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
|
UMS Strategy + SMS Text Messaging
n=180 Participants
In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
|
Usual Care
n=168 Participants
Patients of providers randomized to the usual care arm will receive their standard care
|
|---|---|---|---|
|
Treatment Knowledge
|
0.73 Probability of Knowledge
Interval 0.67 to 0.78
|
0.73 Probability of Knowledge
Interval 0.68 to 0.78
|
0.75 Probability of Knowledge
Interval 0.7 to 0.8
|
Adverse Events
UMS Strategy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
UMS Strategy + SMS Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place