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NCT00973180 · ClinicalTrials.gov registry record · NA
Enhanced Prescription Drug Label to Improve Patient Understanding and Use
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 850
- Enrollment target
NCT00973180 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 850 participants.
The verdict
NCT00973180, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 850 participants
- Enrollment target
Study Summary
The overall objective of this study is to test the efficacy of an evidence-based, enhanced Rx container label design to improve patients' understanding of instructions for use. The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container label to improve patients' understanding of actual prescribed medicines, compared to a standard label format. Patients with type II diabetes and/or hypertension at safety-net clinics affiliated with one central-fill pharmacy (Nova Scripts Central - NSC) receive their prescribed medicines from this location. Recruited 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. Other exploratory outcome measures will also be measured, including 1) adverse effects associated with medication use defined by a) the rate of physician visits, b) the rate of emergency room visits, and c) the rate of hospitalizations and hospital admissions via emergency rooms for medication side effects (e.g. hyperglycemia or hypoglycemia); and 2) health outcome as measured by the change from baseline in hemoglobin A1c (HbA1c) and blood pressure measurements. Data from the actual use trial will be processed, reviewed, analyzed (in order of hypotheses),
Interventions
- OTHER Enhanced Label
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 850 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00973180
The ClinicalTrials.gov registry entry for NCT00973180 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 850 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enhanced Label is the first listed.
NCT00973180 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00973180 about?
NCT00973180 is a clinical study titled "Enhanced Prescription Drug Label to Improve 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 patients' understanding of instructions for use. The investigators will conduct a randomized controlled trial (N=960) to evaluate the efficacy of the enhanced Rx container...
What is the current status of trial NCT00973180?
This trial is currently completed. It is a NA study. The enrollment target is 850 participants. The study started on 2009-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00973180?
The interventions under investigation include: Enhanced Label (OTHER).
Who is sponsoring clinical trial NCT00973180?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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