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Patient Understanding of Handouts at Different Reading Levels

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06736808
Enrollment
156
Registered
2024-12-17
Start date
2024-12-19
Completion date
2025-03-21
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Literacy

Keywords

readability, patient understanding

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.

Interventions

OTHERHandout 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.

OTHERHandout 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.

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Must be able to complete pen and paper questionnaire

Exclusion criteria

* Unable to understand or read English

Design outcomes

Primary

MeasureTime frameDescription
Knowledge Assessment ScoreAssessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutesMean 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 UtilityAssessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutesPercentage of participants who respond Yes that reading the handout increased their understanding of pelvic organ prolapse on a Yes/No/Don't know scale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026