Patient Understanding of Handouts at Different Reading Levels

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

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

Study Overview

• Status: Completed
• Conditions: Health Literacy
• Intervention / Treatment: Other: Handout Written at Below a Sixth Grade Reading Level; Other: Handout Written at Above a Sixth Grade Reading Level

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.

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must be able to complete pen and paper questionnaire

Exclusion Criteria:

• Unable to understand or read English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Below Sixth Grade Reading Level; Participants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level.	Other: Handout Written at Below a Sixth Grade Reading Level; Participants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level.
Active Comparator: Above Sixth Grade Reading Level; Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level.	Other: Handout Written at Above a Sixth Grade Reading Level; Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge Assessment Score	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).	Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes
Participant-reported Handout Utility	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.	Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Bertie Geng, MD, University of North Carolina

Publications and helpful links

General Publications

• Shah AD, Massagli MP, Kohli N, Rajan SS, Braaten KP, Hoyte L. A reliable, valid instrument to assess patient knowledge about urinary incontinence and pelvic organ prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Sep;19(9):1283-9. doi: 10.1007/s00192-008-0631-x. Epub 2008 May 15.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: readability; patient understanding
• Other Study ID Numbers: 24-2684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 12 months following publication until 36 months following publication.
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No