Expired Study
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Syracuse, New York 13069


Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - 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.


Study is Available At:


Original ID:

IRBPHS#5229


NCT ID:

NCT00639470


Secondary ID:


Study Acronym:


Brief Title:

Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets


Official Title:

Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

State University of New York - Upstate Medical University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

23


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sharon Kitchie, PhD
Principal Investigator
State University of New York - Upstate Medical University

Study Dates

Start Date:August 2005
Completion Date:August 2008
Completion Type:Actual
Primary Completion Date:March 2007
Primary Completion Type:Actual
Verification Date:August 2008
Last Changed Date:August 12, 2008
First Received Date:March 12, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Comprehension of the fact sheets as measured by the Cloze Readability Procedure.
Time Frame:On the day of discharge
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:easy to read fact sheets
Description:easy to read fact sheets with illustrations and without illustrations
Other Name:patient education handouts

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:State University of New York - Upstate Medical University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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