Health Education in Improving the Understanding of Medical Information

August 28, 2013 updated by: Dartmouth-Hitchcock Medical Center

Randomized Trial of a Primer to Help Patients Understand Risk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare medical data interpretation skills in participants of low or high socioeconomic status who receive a general education primer (entitled "Know Your Chances: Understanding Health Statistics") vs a health education booklet (entitled "The Pocket Guide to Good Heath for Adults").

OUTLINE: This is a randomized, controlled study. Participants are stratified according to socioeconomic status (low vs high). Participants are randomized to 1 of 2 intervention arms.

  • Arm I (control): Participants receive a health education booklet entitled "The Pocket Guide to Good Health for Adults," published by the Agency for Health Care Research and Quality, which contains general information about disease risk and reducing risk by following recommended prevention or screening activities.
  • Arm II (primer): Participants receive a general education primer entitled "Know your chances: Understanding health statistics," which teaches how to understand disease risk and the benefits and risks of intervention.

Within 2 weeks after receiving the education material, participants in both arms complete a survey, including a medical data interpretation test, STAT-interest, STAT-confidence, and user ratings of the education materials.

PROJECTED ACCRUAL: A total of 555 participants were accrued for this study.

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risk primer
Booklet written by investigators "know your chances"
Other: Risk primer
Know your chances booklet
Other Names:
  • Know your chances
Active Comparator: Control booklet
AHRQ staying healthy booklet
Other: AHRQ staying healthy booklet
educational booklet about prevention
Other Names:
  • AHRQ guide to staying healthy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ability to interpret medical statistics as measured by a medical data interpretation test
Time Frame: 2 weeks
medical data interpretation skills
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interest in interpreting medical statistics, as measured by STAT-interest
Time Frame: 2 weeks
STAT-interest measure
2 weeks
Confidence in interpreting medical statistics, measured by STAT-confidence
Time Frame: 2 weeks
STAT-confidence
2 weeks
User ratings of materials
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Steven Woloshin, MD, MS, White River Junction Veterans Affairs Medical Center
  • Principal Investigator: Lisa Schwartz, MD, MS, White River Junction Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

October 12, 2006

First Submitted That Met QC Criteria

October 12, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CDR0000510867
  • R18CA091052 (U.S. NIH Grant/Contract)
  • DMS-15144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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