Medication UnderstandingNCT01200849
Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use
A study testing Enhanced Label in people with Medication Understanding and Diabetes, run by Northwestern University at 1 site in United States.
Trial summary
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Medication Understanding, Diabetes, Hypertension
- What is being tested?
- Enhanced Label
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or hypertension in their medical chart
- Spanish speaking
- 30 years or older
Who cannot join
- Uncorrectable hearing or visual impairment.
- Too ill to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use.
Read the detailed description
The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. Spanish-speaking patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive all their prescribed medicines from this location. Recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. We anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.
- Conditions
- Medication Understanding, Diabetes, Hypertension
- Being tested
- Enhanced Label
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced LabelOther
A prescription drug label that has simplified text, more white space and overall is more patient-friendly.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Label | Experimental | Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label. Receives: Other: Enhanced Label |
| Standard Label | No intervention | Subjects in this arm will receive their prescriptions labeled with a standard label. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of prescription medication
Difference in understanding and comprehension of medication use as compared to control.
Measured: Baseline, 3 month follow-up, 9 month follow-up
Secondary outcomes (1)
Change in HbA1c or blood pressure readings
Measured: Baseline, 3 month follow-up, 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication UnderstandingStudies 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
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- 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
- NCT01200849
- Sponsor's protocol ID
- STU00005495
- Status last verified
- Nov 2014
- First submitted
- 2 Sep 2010
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016 Dec;31(12):1482-1489. doi: 10.1007/s11606-016-3816-x. Epub 2016 Aug 19.
PubMed 27542666
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use
- ClinicalTrials.gov ID
- NCT01200849
- Acronym / sponsor ID
- STU00005495
- Conditions
- Medication Understanding, Diabetes, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Oct 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve Spanish speaking patients' understanding of instructions for use.
Detailed description
The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve, Spanish speaking, diabetic and/or hypertensive patients' understanding of actual prescribed medicines, compared to a standard label format. Spanish-speaking patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive all their prescribed medicines from this location. Recruited diabetic and/or hypertensive subjects in this study will be randomly assigned to either intervention (enhanced Rx container label) or control (standard Rx label). All pill-form, regular dosing schedule medicines, including diabetes and hypertensive (i.e. ACE inhibitor) medicines associated with patients' treatment will be labeled according to study arm by the central-fill pharmacy. Study subjects will be interviewed at the time of dispensing the prescribed medicines at the clinic, again three months later (dispensing of refill), and finally nine months after baseline (dispensing of refill). Pharmacy refill data and medical record information - linked at these clinics - will be collected for exploratory analyses. Patients' ability to read and demonstrate Rx label instructions, including auxiliary warnings, will be the primary outcomes for this aim. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses), and reports prepared during the final months of this last phase of the study. We anticipate several manuscripts to be developed as a result of this project, supported by the diverse key personnel and collaborating faculty enlisted.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Label | Experimental | Other: Enhanced LabelSubjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label. |
| Standard Label | No intervention | –Subjects in this arm will receive their prescriptions labeled with a standard label. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Type II diabetes or hypertension in their medical chart
- Spanish speaking
- 30 years or older
Key exclusion criteria (2 listed)
- Uncorrectable hearing or visual impairment.
- Too ill to participate
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 |
|---|---|---|
| Enhanced LabelA prescription drug label that has simplified text, more white space and overall is more patient-friendly. | Other | Enhanced Label |
Primary outcome
Understanding of prescription medication
Time frame: Baseline, 3 month follow-up, 9 month follow-up
Difference in understanding and comprehension of medication use as compared to control.
1 secondary outcome
Change in HbA1c or blood pressure readings
Time frame: Baseline, 3 month follow-up, 9 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Derived from this study: PubMed 27542666Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016 Dec;31(12):1482-1489. doi: 10.1007/s11606-016-3816-x. Epub 2016 Aug 19.
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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 Enhanced Label in people with Medication Understanding and 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 3 inclusion and 2 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 18 Nov 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Understanding of prescription medication (time frame: Baseline, 3 month follow-up, 9 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01200849, which also lists 1 linked publication.
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 18 Nov 2014.