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Clinical Trials/NCT06736808
NCT06736808
Completed
N/A

Assessment of Patient Understanding of Educational Material at Above and Below a Sixth Grade Reading Level

University of North Carolina, Chapel Hill1 site in 1 country156 target enrollmentDecember 19, 2024
ConditionsHealth Literacy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Literacy
Sponsor
University of North Carolina, Chapel Hill
Enrollment
156
Locations
1
Primary Endpoint
Knowledge Assessment Score
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of this randomized clinical trial is to learn if participants are better able to understand medical handouts written at below a sixth grade reading level compared to those written at above a sixth grade reading level. The main question it aims to answer is:

• Do participants score higher on a knowledge test after reading a handout written at below a sixth grade reading level compared to after reading a handout written at above a sixth grade reading level?

Researchers will compare knowledge scores on pelvic organ prolapse after participants read a handout written at an eight grade reading level compared to the same handout re-written to be at a fifth grade reading level.

Participants will:

  • Read a one page handout (written at either above or below a sixth grade reading level) on pelvic organ prolapse
  • Complete a one page multiple-choice test on pelvic organ prolapse

Detailed Description

The secondary objective is to determine characteristics of patients whose knowledge levels are higher after reading educational material written below a sixth grade reading level compared to material written above a sixth grade reading level.

Registry
clinicaltrials.gov
Start Date
December 19, 2024
End Date
March 21, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Must be able to complete pen and paper questionnaire

Exclusion Criteria

  • Unable to understand or read English

Outcomes

Primary Outcomes

Knowledge Assessment Score

Time Frame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes

Mean number of correct answers from 0 to 12 on the validated Prolapse Knowledge Questionnaire where 0 indicates 0 correct answers (worst knowledge score) and 12 indicates all correct answers (best knowledge score).

Participant-reported Handout Utility

Time Frame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes

Percentage of participants who respond "Yes" that reading the handout increased their understanding of pelvic organ prolapse on a Yes/No/Don't know scale.

Study Sites (1)

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