NCT00450931

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 standard brief summary in helping patients and doctors understand medical information.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
Last Updated

January 6, 2014

Status Verified

September 1, 2008

First QC Date

March 20, 2007

Last Update Submit

January 3, 2014

Conditions

Health Status Unknown

Keywords

health status unknown

Outcome Measures

Primary Outcomes (2)

  • Comparison of two drugs for the same indication

  • Knowledge of drug efficacy and side effects of each drug

Secondary Outcomes (1)

  • Comprehension of information contained in the drug facts box and rating of the usability of the drug information

Interventions

counseling interventionOTHER
educational interventionOTHER

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * English-speaking adults * Must be able to be chosen by Random Digit Dialing PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Interventions

CounselingEarly Intervention, Educational

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Steven Woloshin, MD, MS

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Harold Bae

    White River Junction Veterans Affairs Medical Center

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Sponsor Type
FED

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Last Updated

January 6, 2014

Record last verified: 2008-09