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Enhanced Prescription Drug Label to Improve Patient Understanding and
Use This study is currently recruiting participants. Verified by
Northwestern University, September 2009 First Received: September 8,
2009 No Changes Posted

Sponsor:

Northwestern University

Information provided by:

Northwestern University

ClinicalTrials.gov Identifier:

NCT00973180

Purpose

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), and reports
prepared during the final months of this last phase of the study.

Condition

Intervention

Prescription Medication Understanding

Other: Enhanced Label

Study Type:

Interventional

Study Design:

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Official Title:

Enhanced Prescription Drug Label to Improve Patient Understanding and
Use

Resource links provided by NLM:
MedlinePlus related topics: Diabetes High Blood Pressure U.S. FDA
Resources
Further study details as provided by Northwestern University:
Primary Outcome Measures:

Understanding of prescription medication	Time Frame: Baseline, 3
months, 9 months Designated as safety	issue: No

Secondary Outcome Measures:

Change in HbA1c or blood pressure readings	Time Frame: Baseline,
3 months, 9 months Designated as safety	issue: No

Estimated Enrollment:

726

Study Start Date:

May 2009

Estimated Study Completion Date:

May 2011

Estimated Primary Completion Date:

August 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Enhanced Label: Experimental Subjects in this arm will receive their
prescriptions labeled with our enhanced, patient-friendly label.

Other: Enhanced Label A prescription drug label that has simplified
text, more white space and overall is more patient-friendly.

Standard Label: No Intervention Subjects in this arm will receive
their prescriptions labeled with a standard label.

Eligibility

Ages Eligible for Study:

30 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Diagnosis of Type II diabetes or hypertension in their medical
 chart.

30 years or older.

Fluent in English.

Exclusion Criteria:

Uncorrectable hearing or visual impairment.

Too ill to participate.

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier:
NCT00973180

Contacts

Contact: Anjali Pandit, MPH

(312) 503-5597

a-pandit@northwestern.edu

Locations

United States, Illinois

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contact: Anjali Pandit, MPH 312-503-5507 a-pandit@northwestern.edu

Principal Investigator: Michael S. Wolf, PhD, MPH

Sponsors and CollaboratorsNorthwestern UniversityInvestigators

Principal Investigator:

Michael S. Wolf, PhD, MPH

Northwestern University

More Information
No publications provided

Responsible Party:

Northwestern University ( Michael S. Wolf, PhD, MPH )

Study ID Numbers:

NU-0923017

Study First Received:

September 8, 2009

Last Updated:

September 8, 2009

ClinicalTrials.gov Identifier:

NCT00973180 History of Changes

Health Authority:

United States: Institutional Review Board

Keywords provided by Northwestern University:

Prescription medication understanding among diabetic and hypertension
patients.
Prescription medication use among diabetic and hypertension patients.
Hemoglobin A1C changes among diabetic patients.
Blood pressure changes among hypertension patients.

ClinicalTrials.gov processed this record on March 18, 2010

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