Type 2 DiabetesNCT02248857
Promoting the Universal Medication Schedule Via Mobile and EHR Technologies
A study testing UMS Strategy and SMS Texting Reminders in people with Type 2 Diabetes, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- UMS Strategy and SMS Texting Reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2016
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of type II diabetes
- age 30 or older
- taking 3 or more prescription medications for chronic conditions
- English or Spanish speaking
Who cannot join
- self-reported severe, uncorrectable vision
- hearing impairment
- cognitive impairment
- not responsible for administering his/her own medications
- not able to receive text messages on their cell phone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial
The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.
Read the detailed description
Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.
We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.
- Conditions
- Type 2 Diabetes
- Being tested
- UMS Strategy, SMS Texting Reminders
- Keywords
- UMS, medication schedule, diabetes, drug labeling
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UMS StrategyOther
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 Texting RemindersOther
In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Employ the current standard of care. No intervention. |
| 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.
1. Prescription instructions will be adapted to UMS to establish four standard time intervals 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 content from a patient's perspective and following health literacy best practices.
3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines. Receives: Other: UMS Strategy |
| UMS strategy + SMS texting reminders | Experimental | In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. Receives: Other: UMS Strategy; Other: SMS Texting Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Understanding
Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.
Measured: 6 months after baseline
Secondary outcomes (4)
Medication Knowledge
Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.
Measured: 6 months after baseline
Medication Adherence: Pill Count
Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.
Measured: 6 months after baseline
Medication Adherence: PMAQ
Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.
Measured: 6 months after baseline
Medication Adherence: Pharmacy Records
Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.
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 posted25 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
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 Type 2 DiabetesStudies 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
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- 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
- NCT02248857
- Sponsor's protocol ID
- STU00097744
- Status last verified
- Dec 2018
- First submitted
- 22 Sep 2014
- Last updated
- 25 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial
- ClinicalTrials.gov ID
- NCT02248857
- Acronym / sponsor ID
- STU00097744
- Conditions
- Type 2 Diabetes
- Keywords
- UMS, medication schedule, diabetes, drug labeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 25 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.
Detailed description
Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.
We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Employ the current standard of care. No intervention. |
| UMS strategy | Experimental | Other: 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. 1. Prescription instructions will be adapted to UMS to establish four standard time intervals 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 content from a patient's perspective and following health literacy best practices. 3. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines. |
| UMS strategy + SMS texting reminders | Experimental | Other: UMS Strategy, Other: SMS Texting RemindersIn addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of type II diabetes
- age 30 or older
- taking 3 or more prescription medications for chronic conditions
- English or Spanish speaking
Key exclusion criteria (5 listed)
- self-reported severe, uncorrectable vision
- hearing impairment
- cognitive impairment
- not responsible for administering his/her own medications
- not able to receive text messages on their cell phone
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. | Other | UMS strategy, UMS strategy + SMS texting reminders |
| SMS Texting RemindersIn addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. | Other | UMS strategy + SMS texting reminders |
Primary outcome
Prescription Understanding
Time frame: 6 months after baseline
Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.
4 secondary outcomes
Medication Knowledge
Time frame: 6 months after baseline
Medication Adherence: Pill Count
Time frame: 6 months after baseline
Medication Adherence: PMAQ
Time frame: 6 months after baseline
Medication Adherence: Pharmacy Records
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 25 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site 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 Texting Reminders in people with Type 2 Diabetes, run by Northwestern University at 1 site 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 4 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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 25 Mar 2019). 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?
Prescription Understanding (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 25 Mar 2019; AzTrials last refreshed its copy on 31 Oct 2026.