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| Tracking Information | |||||
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| First Received Date ICMJE | August 26, 2005 | ||||
| Last Updated Date | June 6, 2006 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
after one month: scores on the Asthma Action Plan Knowledge Interview and Family Satisfaction Survey, and mean daily adherence to controller medication and total number of puffs of rescue medication inhaled | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00136305 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparing Asthma Action Plans for Pediatric Asthma | ||||
| Official Title ICMJE | Relative Effectiveness of Pictorial and Written Asthma Action Plans for Pediatric Asthma | ||||
| Brief Summary | The purpose of this study is to evaluate and compare the relative effectiveness of two asthma action plans (pictorial versus written) in terms of asthma action plan knowledge, medication use, and family satisfaction with asthma education. |
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| Detailed Description | Asthma medical regimens are complex for families, requiring changes in the types and amounts of medication based on the frequency and intensity of symptoms. Written asthma action plans (AAP’s) are commonly used to provide a set of instructions to help parents and children implement these complicated regimens. However, written AAP’s require substantial literacy levels, so for younger children, low-literacy families, or non-English speaking families, a pictorial version of the AAP may be more understandable and useful. The study aims to validate a newly developed, fully pictorial AAP in terms of its relative impact on parent- and child-reported knowledge of the action plan, medication use, and parent- and child-reported satisfaction, when compared to a standard-care written AAP. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Device: Pictorial asthma action plan | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | November 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00136305 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 04 08-102E, KBR 01.4182 | ||||
| Study Sponsor ICMJE | Children's Mercy Hospital Kansas City | ||||
| Collaborators ICMJE | Katherine B. Anderson Associates Endowment Fund | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Mercy Hospital Kansas City | ||||
| Verification Date | November 2005 | ||||
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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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