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OpenTrials
Completed

NCT Number: NCT06736808

Patient Understanding of Handouts at Different Reading Levels

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

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Key information

Conditions

Health Literacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, 27607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to complete pen and paper questionnaire

Exclusion criteria

  • Unable to understand or read English

Treatment and study plan

Handout Written at Below a Sixth Grade Reading Level

Other

Participants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level.

Handout Written at Above a Sixth Grade Reading Level

Other

Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level.

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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