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OpenTrials
Completed

NCT Number: NCT00753857

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

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.

Completed

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Key information

Conditions

Healthy

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA Medical Center

White River Junction, Vermont, 05009, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-English speaking

Treatment and study plan

Drug Facts Box

Other

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

Standard Brief Summary

Other

Ads consisted of the standard second page called the brief summary

Primary outcomes

  1. 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

Secondary outcomes

  1. Comprehension of information contained in the drug facts box

    Time frame: Immediate return of patient survey

Sponsors and collaborators

Lead sponsor

White River Junction Veterans Affairs Medical Center

Fed

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 17, 2008
Registry last updated
Sep 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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