ParentsNCT00639470
Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets
A study testing easy to read fact sheets in people with Parents, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The objective of this study is to test legal guardians reading comprehension of their child's post-operative medication administration using three different versions of written medication information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets accompanied by illustrations). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents
- What is being tested?
- easy to read fact sheets
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be 18 years of age or older or an emancipated minor
- ability to see, speak, and hear English
- have a child who will be undergoing surgery
- signed surgical consent form
- have a child staying on hospital pediatric surgical unit after surgery until discharge
- have a child admitted for at least one day but not more than 7 days.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13069
About this study
Official title: Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact
The objective of this study is to test legal guardians reading comprehension of their child's post-operative medication administration using three different versions of written medication information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets accompanied by illustrations).
Read the detailed description
It is important for the child's welfare and comfort that the legal guardian can read and comprehend their child's pain medication information. Failure to understand the full implications of the medication may jeopardize the child's comfort level or welfare. Readability of printed education materials is a key to comprehension and supplements what healthcare providers verbally tell the parents/legal guardians. Several studies have demonstrated the benefits of using illustrations to convey intended messages. Simple line drawings appear to do well with those who have low-literacy skills.
The following hypothesis will be tested:
- There is no difference in level of comprehension of medication administration by the legal guardians who receive standard fact sheets about medication, those who receive easy-to-read fact sheets, and those who receive easy-to-read fact sheets accompanied by illustrations.
- There is no difference in level of comprehension of pain assessment by the legal guardians who receive standard fact sheets about assessing pain, those who receive easy-to-read fact sheets, and those who receive easy-to-read facts sheets accompanied by illustrations.
- There is no relationship between legal guardians' satisfaction with medication education and whether they receive standard fact sheets, easy-to-read fact sheets, or those who receive easy-to read fact sheets accompanied by illustrations.
- Conditions
- Parents
- Being tested
- easy to read fact sheets
- Keywords
- Patient Education Handout, Parents, Patient Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
easy to read fact sheetsOther
Also called patient education handouts
easy to read fact sheets with illustrations and without illustrations
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of the fact sheets as measured by the Cloze Readability Procedure.
Measured: On the day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startAug 2005
- Primary completionMar 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Sharon Kitchie, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639470
- Sponsor's protocol ID
- IRBPHS#5229
- Status last verified
- Aug 2008
- First submitted
- 12 Mar 2008
- Last updated
- 13 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact
- ClinicalTrials.gov ID
- NCT00639470
- Acronym / sponsor ID
- IRBPHS#5229
- Conditions
- Parents
- Keywords
- Patient Education Handout, Parents, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Mar 2008 (estimated)
- 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 objective of this study is to test legal guardians reading comprehension of their child's post-operative medication administration using three different versions of written medication information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets accompanied by illustrations).
Detailed description
It is important for the child's welfare and comfort that the legal guardian can read and comprehend their child's pain medication information. Failure to understand the full implications of the medication may jeopardize the child's comfort level or welfare. Readability of printed education materials is a key to comprehension and supplements what healthcare providers verbally tell the parents/legal guardians. Several studies have demonstrated the benefits of using illustrations to convey intended messages. Simple line drawings appear to do well with those who have low-literacy skills.
The following hypothesis will be tested:
- There is no difference in level of comprehension of medication administration by the legal guardians who receive standard fact sheets about medication, those who receive easy-to-read fact sheets, and those who receive easy-to-read fact sheets accompanied by illustrations.
- There is no difference in level of comprehension of pain assessment by the legal guardians who receive standard fact sheets about assessing pain, those who receive easy-to-read fact sheets, and those who receive easy-to-read facts sheets accompanied by illustrations.
- There is no relationship between legal guardians' satisfaction with medication education and whether they receive standard fact sheets, easy-to-read fact sheets, or those who receive easy-to read fact sheets accompanied by illustrations.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 18 years of age or older or an emancipated minor
- ability to see, speak, and hear English
- have a child who will be undergoing surgery
- signed surgical consent form
- have a child staying on hospital pediatric surgical unit after surgery until discharge
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| easy to read fact sheetsAlso: patient education handoutseasy to read fact sheets with illustrations and without illustrations | Other | – |
Primary outcome
Comprehension of the fact sheets as measured by the Cloze Readability Procedure.
Time frame: On the day of discharge
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 13 Aug 2008.
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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.
Sharon Kitchie, PhD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing easy to read fact sheets in people with Parents, run by State University of New York - Upstate Medical University 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 6 inclusion and 0 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 13 Aug 2008. 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?
Comprehension of the fact sheets as measured by the Cloze Readability Procedure. (time frame: On the day of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.