Health LiteracyNCT06736808
Patient Understanding of Handouts at Different Reading Levels
A study testing Handout Written at Below a Sixth Grade Reading Level and Handout Written at Above a Sixth Grade Reading Level in people with Health Literacy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- What is being tested?
- Handout Written at Below a Sixth Grade Reading Level and Handout Written at Above a Sixth Grade Reading Level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to complete pen and paper questionnaire
Who cannot join
- Unable to understand or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX
Raleigh, North Carolina, 27607
About this study
Official title: 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?
Read more
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
Read the 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.
- Conditions
- Health Literacy
- Being tested
- Handout Written at Below a Sixth Grade Reading Level, Handout Written at Above a Sixth Grade Reading Level
- Keywords
- readability, patient understanding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handout Written at Below a Sixth Grade Reading LevelOther
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 LevelOther
Participants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Handout Written at Above a Sixth Grade Reading Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start19 Dec 2024
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertie Geng, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736808
- Sponsor's protocol ID
- 24-2684
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 18480958
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Understanding of Educational Material at Above and Below a Sixth Grade Reading Level
- ClinicalTrials.gov ID
- NCT06736808
- Acronym / sponsor ID
- 24-2684
- Conditions
- Health Literacy
- Keywords
- readability, patient understanding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Below Sixth Grade Reading Level | Experimental | Other: Handout Written at Below a Sixth Grade Reading LevelParticipants 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 | Active comparator | Other: Handout Written at Above a Sixth Grade Reading LevelParticipants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be able to complete pen and paper questionnaire
Key exclusion criteria (1 listed)
- Unable to understand or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handout Written at Below a Sixth Grade Reading LevelParticipants randomized to this experimental arm will read a simplified handout on pelvic organ prolapse written at below a sixth grade reading level. | Other | Below Sixth Grade Reading Level |
| Handout Written at Above a Sixth Grade Reading LevelParticipants randomized to this control arm will read a standard handout on pelvic organ prolapse written at above a sixth grade reading level. | Other | Above Sixth Grade Reading Level |
Primary outcome
Knowledge Assessment Score
Time frame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes
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).
Participant-reported Handout Utility
Time frame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 18480958Shah 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertie Geng, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handout Written at Below a Sixth Grade Reading Level and Handout Written at Above a Sixth Grade Reading Level in people with Health Literacy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Assessment Score (time frame: Assessed during completion of a 5 minute survey after reading a one page informational handout for approximately 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.