The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00753857|
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : September 17, 2008
The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.
This randomized trial is studying how well a drug facts page works compared with a short drug summary in helping patients and doctors understand medical information.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Drug Facts Box Other: Standard Brief Summary||Phase 3|
This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 2 intervention arms.
- Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug, perceptions of drug efficacy and side effects of each drug
- Comprehension of information contained in the drug facts box
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.
Other: Drug Facts Box
Educational intervention of 1 page summary of drug efficacy and side effects
Active Comparator: 2
Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)
Other: Standard Brief Summary
Ads consisted of the standard second page called the brief summary
- Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events [ Time Frame: Immediate return of patient survey ]
- Comprehension of information contained in the drug facts box [ Time Frame: Immediate return of patient survey ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753857
|United States, Vermont|
|VA Medical Center|
|White River Junction, Vermont, United States, 05009|
|Principal Investigator:||Steven Woloshin, MD, MS||Dartmouth Medical School; VA Medical Center (WRJ)|
|Principal Investigator:||Lisa M Schwartz, MD, MS||Dartmouth Medical School, VA Medical Center (WRJ)|