Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
231 participants
INTERVENTIONAL
2004-09-30
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Asthma Communication Education
2
Standard Asthma Education
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Asthma Communication Education
Standard Asthma Education
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Physician diagnosis of asthma
* Reside in metropolitan Baltimore
* English speaking
* Able to read 80% of parent educational brochure in English
* Emergency Department (ED) visit within the past 12 months and can identify a primary care provider
* No other co-morbid pulmonary disease
Exclusion Criteria
6 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institutes of Health (NIH)
NIH
National Institute of Nursing Research (NINR)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Johns Hopkins University, Department of Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arlene Butz, SCD,MSN,BSN
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins University
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Logan J and Butz AM. Improving asthma communication in minority families - ongoing pilot study. Am J Respir and Crit Care Med. 2004; Abstract No. 5119, American Thoracic Society International Meeting, Orlando, FL, May 2004. Butz AM. Effective asthma communication: Children and primary care providers. European Respiratory Society Annual Congress. September 2004, Glasgow, Scotland.
Butz A, Kub J, Donithan M, James NT, Thompson RE, Bellin M, Tsoukleris M, Bollinger ME. Influence of caregiver and provider communication on symptom days and medication use for inner-city children with asthma. J Asthma. 2010 May;47(4):478-85. doi: 10.3109/02770901003692793.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
03-11-11-05
Identifier Type: -
Identifier Source: org_study_id