Internet-Based Program to Improve Asthma Management in Children
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | September 14, 2006 | ||||
| Last Updated Date | February 11, 2009 | ||||
| Start Date ICMJE | July 2007 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00377663 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 | Internet-Based Program to Improve Asthma Management in Children | ||||
| Official Title ICMJE | Internet-Based Patient-Centered Asthma Management System | ||||
| Brief Summary | Asthma is a respiratory condition that affects millions of children. It can be controlled, however, with the proper medications and treatment. AsthmaNet, an internet-based asthma management system, aims to improve the asthma care of children by providing their parents and doctors with appropriate tools and feedback related to asthma management. The purpose of this study is to evaluate the effectiveness of AsthmaNet at improving quality of care and controlling asthma symptoms in children. |
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| Detailed Description | In the United States, almost 9 million children have been diagnosed with asthma. It is a leading cause of hospitalization, chronic disease, and school absenteeism. With the proper treatment, most children with asthma are able to lead a normal life. However, if asthma is not adequately controlled, it can be a life-threatening disease. It is important for parents to work with their child's doctor to develop a comprehensive treatment plan that minimizes asthma symptoms. AsthmaNet, an interactive web-based system, aims to improve the quality of care for children with asthma by enhancing parents' asthma care skills and encouraging parents to discuss their child's asthma care with their doctor. AsthmaNet provides evidence-based guidelines, asthma management tools, and individually tailored feedback to both parents and physicians to improve communication and enhance asthma management skills and behaviors. The goal of this study is to evaluate the effectiveness of AsthmaNet at increasing medication and treatment adherence in children with asthma. This 1-year study will enroll young children with asthma. Participants will be randomly assigned to either use the AsthmaNet web site or not use the web site. The web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition. All children will attend regularly scheduled doctor's appointments for asthma and receive their usual care; there are no additional study visits specifically for this study. Study researchers will review medical records to analyze medication usage and asthma symptoms. Participants in the AsthmaNet group will complete questionnaires on a monthly basis to assess asthma status; the control group will complete questionnaires at Month 6 and Year 1. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Behavioral: AsthmaNet
The AsthmaNet Web site will provide parents of children in the AsthmaNet group with individualized clinical information regarding their child's asthma care and with decision-making aids that they can share with their child's doctor. The web site will also prompt parents to make additional doctor appointments, as needed, to discuss their child's condition. |
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| Study Arm (s) |
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| Publications * | Christakis DA, Garrison MM, Lozano P, Meischke H, Zhou C, Zimmerman FJ. Improving parental adherence with asthma treatment guidelines: a randomized controlled trial of an interactive website. Acad Pediatr. 2012 Jul-Aug;12(4):302-11. Epub 2012 Jun 11. | ||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | August 2009 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 10 Years | ||||
| 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 | NCT00377663 | ||||
| Other Study ID Numbers ICMJE | 431, R01 HL079402-01A2 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dimitri A. Christakis, MD, MPH, University of Washington | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | February 2009 | ||||
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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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