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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | January 20, 2006 | ||||
| Start Date ICMJE | August 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005523 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Home Based Environmental Adherence Trial | ||||
| Official Title ICMJE | |||||
| Brief Summary | To conduct a randomized trial in asthmatic children to compare the effectiveness of a home-based allergen control program with a customary educational program delivered in offices |
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| Detailed Description | DESIGN NARRATIVE: Two-hundred-forty children, 6 to 17 years of age, were recruited to participate in the study. Following the collection of baseline data, all families in the study received standard environmental control education prior to randomization to the control or experimental group. This education provided parents and children with information about such topics as the child's sensitivity profile, the relationship between exposure to allergens and asthma, and the risks of passive smoking. All families were given information on how to receive environmental control aids and services available by mail at no or reduced costs. Once families were randomized, those in the control group received no additional intervention. Those in the experimental group received a home-based allergen control intervention delivered by trained environmental counselors. Primary outcomes were changes in asthma-related quality of life and changes in targeted allergen levels in the home. Secondary outcome measures included self-efficacy for environmental allergy control, FEV1, and parent-reported health care utilization. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| 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 | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | December 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||
| Ages | 6 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005523 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 5050 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | January 2006 | ||||
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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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