MedDataX Logo

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

NCT ID: NCT00753857

Last Updated: 2008-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

risk communication probability sample by random digit dialing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Participants received 2 ads for drugs to reduce cardiovascular risk with drug facts boxes second pages.

Group Type EXPERIMENTAL

Drug Facts Box

Intervention Type OTHER

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

2

Participants receive the same 2 advertisements for drugs to reduce cardiovascular risk with the standard second page (i.e., brief summary)

Group Type ACTIVE_COMPARATOR

Standard Brief Summary

Intervention Type OTHER

Ads consisted of the standard second page called the brief summary

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drug Facts Box

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

Intervention Type OTHER

Standard Brief Summary

Ads consisted of the standard second page called the brief summary

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Non-English speaking
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

VA Outcomes Group

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven Woloshin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth Medical School; VA Medical Center (WRJ)

Lisa M Schwartz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Dartmouth Medical School, VA Medical Center (WRJ)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Medical Center

White River Junction, Vermont, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCT00386932

Identifier Type: -

Identifier Source: secondary_id

DMS-15879-2

Identifier Type: -

Identifier Source: org_study_id