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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01451944
Other study ID # 11.0320
Secondary ID
Status Withdrawn
Phase N/A
First received October 4, 2011
Last updated December 1, 2014
Start date October 2011
Est. completion date December 2014

Study information

Verified date December 2014
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of our program is to evaluate the effect of home health nurse intervention and education on hospital admissions, ER utilization and asthma control of Passport asthma patients. The investigators hypothesize that case management and in home education by nurses will decrease hospitalizations and ER asthma visits and improves disease control in our population.

Our clinic population consists of primarily inner-city, low income, medicaid recipients. This population suffers from severe asthma much more than the typical pediatric population. Asthma remains the most frequent cause of hospital admission for our patient population. Home health nurse asthma education and home visits have been reported to reduce asthma triggers in the home and improve asthma control. The unique partnership between the pediatrician and the home health nurse will give us a better understanding of the health needs for this population, will improve quality of care and deliver more cost effective care.


Description:

Asthma patients age 3-17 enrolled in our clinic who have been seen in the ER, hospital or clinic for an asthma exacerbation will be invited to participate. Once enrolled they will have a home health nurse visit their home and provide medical assessment, asthma education and determine if the patients has all needed medications available. They enrolled patient will receive another home visit at 1, 4, and 12 months after enrollment. The medical record will be reviewed and ER visits and hospitalizations recorded.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 17 Years
Eligibility Inclusion Criteria:

- Children age 3-17 years with asthma who attend our clinic who present with an asthma exacerbation to the clinic, ER or hospital.

Exclusion Criteria:

- Patients with airway anomalies or tracheostomy

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
education
home asthma case management and education

Locations

Country Name City State
United States Children and Youth Project Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decreased asthma hospitalization rates patients will be followed for 1 year 1 year No
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