Patient Understanding of Handouts at Different Reading Levels

NCT06736808 | Completed

• 1 other identifier: 24-2684
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Conditions

Health Literacy

Keywords

readability; patient understanding

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Below Sixth Grade Reading Level

EXPERIMENTAL

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

Above Sixth Grade Reading Level

ACTIVE COMPARATOR

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

Interventions

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.

Below 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.

Above Sixth Grade Reading Level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to complete pen and paper questionnaire

You may not qualify if:

• Unable to understand or read English

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, 27607, United States

Location

Related Publications (1)

• 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.

  PMID: 18480958 BACKGROUND

Study Officials

• Bertie Geng, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: December 19, 2024
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 12 months following publication until 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)