Diabetes Mellitus, Type 2NCT03185741
Regimen Education and Messaging in Diabetes (REMinD)
A study testing UMS Strategy and SMS Text Messaging in people with Diabetes Mellitus, Type 2 and Medication Adherence, run by Northwestern University at 2 sites in United States.
Trial summary
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Medication Adherence
- What is being tested?
- UMS Strategy and SMS Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 767 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus diagnosis
- Most recent hba1c value ≥7.5%.
- Seek care at participating general internal medicine practices in Chicago or New York City.
- English or Spanish speaking
- Take 5 or more prescription drugs for chronic conditions (including 1 study medication)
Who cannot join
- Severe uncorrectable vision or hearing impairment
- Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia)
- Not primarily responsible for administering his/her medications
- Does not own a cell phone that can receive text messages
- Not comfortable receiving text messages
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
- Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
- Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
- Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
- Assess the costs required to deliver either intervention from a health system perspective.
Read the detailed description
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
The investigators will conduct a 3-arm, multi-site trial to test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. The investigators will enroll a total of 900 English and Spanish-speaking patients with poorly controlled type 2 diabetes mellitus. Enrolled patients will complete follow-up interviews 3 and 6 months following their baseline interview.
The aims of the investigation are to:
- Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
- Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
- Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
- Assess the costs required to deliver either intervention from a health system perspective.
- Conditions
- Diabetes Mellitus, Type 2, Medication Adherence
- Being tested
- UMS Strategy, SMS Text Messaging
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMS StrategyBehavioural
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 MessagingBehavioural
Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
| Study group | Role | What they receive |
|---|---|---|
| UMS Strategy | Experimental | 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. Receives: Behavioral: UMS Strategy |
| UMS Strategy + SMS Text Messaging | Experimental | In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. Receives: Behavioral: UMS Strategy; Behavioral: SMS Text Messaging |
| Usual Care | No intervention | Patients of providers randomized to the usual care arm will receive their standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence: Pill Count
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.
Measured: 6 months after baseline
Secondary outcomes (3)
Medication Adherence: 24-hour Recall
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
Measured: 6 months after baseline
Medication Adherence: ASK-12
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.
Measured: 6 months after baseline
Treatment Knowledge
Identification of drug purpose
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start5 Jan 2018
- Primary completion2 Feb 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Emory University, Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Michael S. Wolf, Northwestern University
- Investigators
- Michael Wolf, PhD MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185741
- Sponsor's protocol ID
- R01NR015444
- Status last verified
- Feb 2023
- First submitted
- 8 Jun 2017
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR-based Universal Medication Schedule to Improve Adherence to Complex Regimens
- ClinicalTrials.gov ID
- NCT03185741
- Acronym / sponsor ID
- R01NR015444
- Conditions
- Diabetes Mellitus, Type 2, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 767 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Emory University, Northwestern Memorial Hospital
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Posted 10 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
- Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
- Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
- Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
- Assess the costs required to deliver either intervention from a health system perspective.
Detailed description
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals.
The investigators will conduct a 3-arm, multi-site trial to test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. The investigators will enroll a total of 900 English and Spanish-speaking patients with poorly controlled type 2 diabetes mellitus. Enrolled patients will complete follow-up interviews 3 and 6 months following their baseline interview.
The aims of the investigation are to:
- Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care.
- Determine if the effects of these UMS strategies vary by patients' literacy skills and language.
- Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions.
- Assess the costs required to deliver either intervention from a health system perspective.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UMS Strategy | Experimental | Behavioral: UMS StrategyPatients 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 + SMS Text Messaging | Experimental | Behavioral: UMS Strategy, Behavioral: SMS Text MessagingIn addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months. |
| Usual Care | No intervention | –Patients of providers randomized to the usual care arm will receive their standard care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus diagnosis
- Most recent hba1c value ≥7.5%.
- Seek care at participating general internal medicine practices in Chicago or New York City.
- English or Spanish speaking
- Take 5 or more prescription drugs for chronic conditions (including 1 study medication)
Key exclusion criteria (5 listed)
- Severe uncorrectable vision or hearing impairment
- Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia)
- Not primarily responsible for administering his/her medications
- Does not own a cell phone that can receive text messages
- Not comfortable receiving text messages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UMS StrategyPatients 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. | Behavioural | UMS Strategy, UMS Strategy + SMS Text Messaging |
| SMS Text MessagingPatients will receive daily text message reminders about when to take medicines based on UMS intervals. | Behavioural | UMS Strategy + SMS Text Messaging |
Primary outcome
Medication Adherence: Pill Count
Time frame: 6 months after baseline
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.
3 secondary outcomes
Medication Adherence: 24-hour Recall
Time frame: 6 months after baseline
Medication Adherence: ASK-12
Time frame: 6 months after baseline
Treatment Knowledge
Time frame: 6 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Wolf, PhD MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UMS Strategy and SMS Text Messaging in people with Diabetes Mellitus, Type 2 and Medication Adherence, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence: Pill Count (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.