Testing the Effect of a Warning About New Drugs

Risk Communication Clinical Trial

Official title:

Testing the Effect of a Warning About New Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950131
• Other study ID #: 16784
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: April 8, 2010
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: White River Junction VAMC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2944
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Risk Communication

Intervention

Other:
• Presentation of information about drug approval and level of warning
Presentation of information about date of drug approval with no new drug warning, a non-directive drug box warning or a directive drug box warning

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction VAMC	Attorney General Consumer & Prescriber Education Grant

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypothetical choice of old (vs. newer) drug		0 weeks (assessed during intervention)	No
Secondary	Comprehension of the drug warning and drug information		0 weeks (assessed during intervention)	No