ClinicalTrials.gg
CompletedNCT00387998Updated Aug 30, 2013

Health Education in Improving the Understanding of Medical Information

An interventional study of AHRQ staying healthy booklet and Risk primer in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Dartmouth-Hitchcock Medical Center. Completed. Open to participants aged 35 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-30.

Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
555
Allocation
Randomized
Ages
35 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 486 studies on the registry; 69 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
555 participants (actual)

Study arms

  • Experimental
    Risk primer

    Booklet written by investigators "know your chances"

    Other: Risk primer

  • Active comparator
    Control booklet

    AHRQ staying healthy booklet

    Other: AHRQ staying healthy booklet

Interventions

  • OtherAHRQ staying healthy booklet

    educational booklet about prevention

    Also known as: AHRQ guide to staying healthy

  • OtherRisk primer

    Know your chances booklet

    Also known as: Know your chances

06

What researchers measure

Primary outcomes

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

    medical data interpretation skills

    Time frame: 2 weeks

Secondary outcomes

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

    STAT-interest measure

    Time frame: 2 weeks

  2. Confidence in interpreting medical statistics, measured by STAT-confidence

    STAT-confidence

    Time frame: 2 weeks

  3. User ratings of materials

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17310049 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2004, a primary completion of Aug 2005 and a completion of Aug 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2006
First posted
Oct 13, 2006
Start
Oct 2004
Primary completionActual
Aug 2005
CompletionActual
Aug 2005
Last update
Aug 30, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00387998
Responsible party
Sponsor
First posted
Oct 13, 2006
Start date
Oct 2004
Primary completion
Aug 2005
Completion
Aug 2005
Last update
Aug 30, 2013

Study contacts

Steven Woloshin, MD, MS
principal investigator · White River Junction Veterans Affairs Medical Center
Lisa Schwartz, MD, MS
principal investigator · White River Junction Veterans Affairs Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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