NCT00387998

Brief Summary

RATIONALE: Understanding the risk of disease and prevention and screening activities to lower disease risk may help individuals make informed medical decisions. PURPOSE: This randomized clinical trial is studying how well health education materials help participants understand medical information.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
555

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Shorter than P25 for not_applicable

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, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
Last Updated

August 30, 2013

Status Verified

January 1, 2008

Enrollment Period

10 months

First QC Date

October 12, 2006

Last Update Submit

August 28, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Ability to interpret medical statistics as measured by a medical data interpretation test

    medical data interpretation skills

    2 weeks

Secondary Outcomes (3)

  • Interest in interpreting medical statistics, as measured by STAT-interest

    2 weeks

  • Confidence in interpreting medical statistics, measured by STAT-confidence

    2 weeks

  • User ratings of materials

    2 weeks

Study Arms (2)

Risk primer

EXPERIMENTAL

Booklet written by investigators "know your chances"

Other: Risk primer

Control booklet

ACTIVE COMPARATOR

AHRQ staying healthy booklet

Other: AHRQ staying healthy booklet

Interventions

AHRQ staying healthy bookletOTHER

educational booklet about prevention

Also known as: AHRQ guide to staying healthy
Control booklet
Risk primerOTHER

Know your chances booklet

Also known as: Know your chances
Risk primer

Eligibility Criteria

Age35 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * High socioeconomic status * Attended Dartmouth Community Medical School in the past * Low socioeconomic status * Veteran or family member enrolled in a Veteran Affairs clinic PATIENT CHARACTERISTICS: * English speaking * No more than 1 participant per household 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

Related Publications (1)

  • Woloshin S, Schwartz LM, Welch HG. The effectiveness of a primer to help people understand risk: two randomized trials in distinct populations. Ann Intern Med. 2007 Feb 20;146(4):256-65. doi: 10.7326/0003-4819-146-4-200702200-00004.

    PMID: 17310049DERIVED

Study Officials

  • Steven Woloshin, MD, MS

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

  • Lisa Schwartz, MD, MS

    White River Junction Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

October 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

August 30, 2013

Record last verified: 2008-01