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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00133666
Other study ID # 03-11-11-05
Secondary ID
Status Completed
Phase Phase 2
First received August 19, 2005
Last updated July 16, 2008
Start date September 2004
Est. completion date May 2008

Study information

Verified date July 2008
Source National Institute of Nursing Research (NINR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- Age 6-12 years

- 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:

- Enrolled in another asthma study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms


Intervention

Behavioral:
Asthma Communication Education

Standard Asthma Education


Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Nursing Research (NINR) National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Reduce the cost of asthma health care. 18 Months No
Secondary Fewer emergency room visits 18 Months No
Secondary Less symptoms 18 Months No
Secondary Fewer missed school days 18 Months No
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