Enhanced Spanish Drug Label Study to Promote Patient Unde... | NCT01200849

Studies
Enhanced Spanish Drug Label Study to Promote Patient Understanding and Use

NCT01200849

Sponsor

Northwestern University

Status

Completed

Last Update Posted

Nov 18, 2014Estimated

Enrollment

420Actual

Phase

Not Applicable

Conditions

Medication Understanding
Diabetes
Hypertension

Interventions

Enhanced Label

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Sep 2, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael S. Wolf, Professor, Northwestern UniversityPrincipal Investigator

Lead Sponsor

Northwestern UniversityOTHER

Collaborators

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

420Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enhanced Label	Experimental	Subjects in this arm will receive their prescriptions labeled with our enhanced, patient-friendly label.	Other: Enhanced Label
Standard Label	No Intervention	Subjects in this arm will receive their prescriptions labeled with a standard label.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enhanced Label	Other	A prescription drug label that has simplified text, more white space and overall is more patient-friendly.	Enhanced Label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Understanding of prescription medication	Difference in understanding and comprehension of medication use as compared to control.	Baseline, 3 month follow-up, 9 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c or blood pressure readings		Baseline, 3 month follow-up, 9 month follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Wolf, Phd, MPH	Northwestern University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Chicago	Illinois	60611	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27542666	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D006973	Hypertension

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases