Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets
| Tracking Information | |||||
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| First Received Date ICMJE | March 12, 2008 | ||||
| Last Updated Date | August 12, 2008 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comprehension of the fact sheets as measured by the Cloze Readability Procedure. [ Time Frame: On the day of discharge ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00639470 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets | ||||
| Official Title ICMJE | Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact | ||||
| Brief 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). |
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| 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Parents | ||||
| Intervention ICMJE | Other: easy to read fact sheets
easy to read fact sheets with illustrations and without illustrations
Other Name: patient education handouts |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 23 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00639470 | ||||
| Other Study ID Numbers ICMJE | IRBPHS#5229 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sharon Kitchie, PhD, APRN, BC, SUNY Upstate Medical University | ||||
| Study Sponsor ICMJE | State University of New York - Upstate Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | State University of New York - Upstate Medical University | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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