Improving Asthma Communication in Minority Families
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 19, 2005 | ||||
| Last Updated Date | July 16, 2008 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduce the cost of asthma health care. [ Time Frame: 18 Months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Less symptoms and missed school days, fewer emergency room visits and reduce the cost of asthma health care. | ||||
| Change History | Complete list of historical versions of study NCT00133666 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| 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 | Improving Asthma Communication in Minority Families | ||||
| Official Title ICMJE | Improving Asthma Communication in Minority Families | ||||
| Brief Summary | The purpose of this study is to determine if teaching children with asthma how to talk to their doctor about controlling their asthma including symptom frequency in an asthma diary and medication use techniques, will result in less symptom and missed school days, fewer emergency room visits and reduce the cost of asthma health care. |
||||
| Detailed Description | Children with persistent asthma are often not receiving regular preventive asthma care despite experiencing frequent asthma symptoms. When linked to timely and appropriate asthma medication use, good physician-parent-child communication is associated with a decrease in asthma morbidity and mortality. Removing obstacles to preventive asthma care and improving communication between the parent-children and PCP are two necessary prerequisites to improving asthma outcomes in low-income minority children. We, the researchers at Johns Hopkins University, hypothesize that a culturally-tailored parent and child asthma communication intervention (ACI) designed to teach parent and child communication skills for use with their health care provider regarding asthma symptom severity, medication use, personal goal of treatment and quality of life issues will significantly reduce emergency room utilization for asthma care. We propose to compare this parent/child asthma communication intervention (ACI) to a developed standard asthma education intervention (SAE) designed to increase basic asthma self-management. This study will advance nursing science by improving asthma self-management for school age children, who may be self-administering their asthma medications, yet not participate in receiving information or making their own medical decisions regarding their asthma. The proposed study is targeted at low-income minority school-aged children with evidence of poorly controlled, high-risk asthma. If successful, this intervention could have significant practical applications as a component of asthma nurse-case management, to practice currently being employed by many managed care groups across the country as an intervention for their high-risk/high ED use asthma patients. Because of the high prevalence and enormous health impact of asthma and the disproportionate asthma burden experienced by minority children, the outcome of the proposed study will have significant pediatric nursing applicability. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
||||
| Condition ICMJE | Asthma | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 231 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 6 Years to 12 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 | NCT00133666 | ||||
| Other Study ID Numbers ICMJE | 03-11-11-05 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Arlene Butz, ScD, RN, Johns Hopkins University, Department of Pediatrics | ||||
| Study Sponsor ICMJE | National Institute of Nursing Research (NINR) | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute of Nursing Research (NINR) | ||||
| Verification Date | July 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||