Patient Understanding of Handouts at Different Reading Levels

Not Applicable

Not yet recruiting

• Conditions: Health Literacy

• Registration Number: NCT06736808
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Must be able to complete pen and paper questionnaire

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Exclusion Criteria

• Unable to understand or read English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knowledge Assessment Score	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	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.

Trial Locations

Locations (1)

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX; 🇺🇸 Raleigh, North Carolina, United States