NCT00753857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
Last Updated

September 17, 2008

Status Verified

September 1, 2008

Enrollment Period

7 months

First QC Date

September 16, 2008

Last Update Submit

September 16, 2008

Conditions

Healthy

Keywords

risk communicationprobability sample by random digit dialing

Outcome Measures

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

    Immediate return of patient survey

Secondary Outcomes (1)

  • Comprehension of information contained in the drug facts box

    Immediate return of patient survey

Study Arms (2)

1

EXPERIMENTAL

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

Other: Drug Facts Box

2

ACTIVE COMPARATOR

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

Interventions

Drug Facts BoxOTHER

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

1
Standard Brief SummaryOTHER

Ads consisted of the standard second page called the brief summary

2

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center

White River Junction, Vermont, 05009, United States

Location

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 17, 2008

Study Start

October 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 17, 2008

Record last verified: 2008-09

Locations

US(1)