Patient Understanding of Handouts at Different Reading Levels
NCT ID: NCT06736808
Last Updated: 2025-04-03
Study Results
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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COMPLETED
NA
156 participants
INTERVENTIONAL
2024-12-19
2025-03-21
Brief Summary
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• 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Responsible Party
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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
Countries
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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.
Other Identifiers
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24-2684
Identifier Type: -
Identifier Source: org_study_id
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