Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Northwestern University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01200849
First received: September 2, 2010
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Medication Understanding
Diabetes
Hypertension
Other: Enhanced Label

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Enhanced Spanish Drug Label Design to Promote Patient Understanding and Use

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Understanding of prescription medication [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ] [ Designated as safety issue: No ]
    Difference in understanding and comprehension of medication use as compared to control.


Secondary Outcome Measures:
  • Change in HbA1c or blood pressure readings [ Time Frame: Baseline, 3 month follow-up, 9 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 960
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Label
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.
No Intervention: Standard Label
Subjects in this arm will receive their prescriptions labeled with a standard label.
Other: Enhanced Label
A prescription drug label that has simplified text, more white space and overall is more patient-friendly.

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.

  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
  • Spanish speaking
  • 30 years or older

Exclusion Criteria:

  • Uncorrectable hearing or visual impairment.
  • Too ill to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200849

Contacts
Contact: Kathryn I Davis, MPH 312-503-3292 kathryn-davis@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Michael S Wolf, PhD, MPH         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Michael Wolf, Phd, MPH Northwestern University
  More Information

No publications provided

Responsible Party: Michael S. Wolf, PhD, MPH, Northwestern University
ClinicalTrials.gov Identifier: NCT01200849     History of Changes
Other Study ID Numbers: STU00005495
Study First Received: September 2, 2010
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014