The Drug Facts Box: Helping Consumers Understand Drugs for Risk Reduction

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753857

Enrollment

260

Registered

2008-09-17

Start date

2006-10-31

Completion date

2007-05-31

Last updated

2008-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

risk communication, probability sample by random digit dialing

Brief summary

RATIONALE: 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. PURPOSE: 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.

Detailed description

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

Interventions

OTHERDrug Facts Box

Educational intervention of 1 page summary of drug efficacy and side effects

OTHERStandard Brief Summary

Ads consisted of the standard second page called the brief summary

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Age 35-70 year old in household selected by random digit dialing

Exclusion criteria

* Non-English speaking

Design outcomes

Primary

Measure	Time frame
Comparison of two drugs for the same indication, Knowledge and judgments about 2 drugs to reduce the future risk of cardiovascular events	Immediate return of patient survey

Secondary

Measure	Time frame
Comprehension of information contained in the drug facts box	Immediate return of patient survey

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026