Patient Understanding of Handouts at Different Reading Levels

NCT ID: NCT06736808

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-19

Study Completion Date

2025-03-21

Brief Summary

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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

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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.

Conditions

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Health Literacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Handout Written at Below a Sixth Grade Reading Level

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Handout Written at Above a Sixth Grade Reading Level

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must be able to complete pen and paper questionnaire

Exclusion Criteria

* Unable to understand or read English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertie Geng, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX

Raleigh, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18480958 (View on PubMed)

Other Identifiers

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24-2684

Identifier Type: -

Identifier Source: org_study_id

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