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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01692080
Other study ID # DU Protocol #10-11
Secondary ID
Status Completed
Phase N/A
First received August 7, 2012
Last updated August 5, 2013
Start date January 2010
Est. completion date December 2012

Study information

Verified date August 2013
Source Duquesne University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The primary objective of this study is to document the prevalence and associations between asthma, hypertension, and obesity in children living in Pittsburgh, Pennsylvania and its surrounding regions.

The secondary objective is to determine the impact of various educational interventions on child and caregiver knowledge of asthma.


Description:

The Asthma Program will consist of six screenings and three camps each year, for two consecutive years. Screenings will be conducted in areas where populations are known to be at increased risk for asthma and its complications, such as inner-city, lower socioeconomic, African-American populations. Screenings will be conducted at churches or schools in these areas one month prior to each camp in an effort to identify children with undiagnosed or uncontrolled asthma and refer them to the camps. Camps will also be conducted in areas where populations are known to be at increased risk for asthma and its complications to improve ease of access. Asthma and smoking cessation education will be provided at each camp to children and caregivers. Baseline data will be collected at each camp and assessed. Longitudinal clinical outcomes will be assessed in children attending multiple camps.


Recruitment information / eligibility

Status Completed
Enrollment 231
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria:

- Children, ages 5- 17 years attending the asthma camps and screenings.

Exclusion Criteria:

- Children younger than 5 years of age and adults 18 years of age and older.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Asthma education
Two separate asthma education classes are conducted to target two age groups: 6-10 yrs and 10-15 yrs. With the guidance of pharmacy faculty, student pharmacists develop innovative educational activities directed at three of the most common barriers to proper asthma control: avoidance of asthma triggers; compliance with asthma medications and proper usage of inhalers; and the importance of an asthma action plan. There is a different group of student pharmacists participating in each camp and this allows for variation in educational activities, all reinforcing the same important aspects of optimal asthma management. Students create age-appropriate activities for each group. Parents are required to attend camps with their child and participate in the asthma education sessions.

Locations

Country Name City State
United States Duquesne University Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Duquesne University Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome of this study is to document the prevalence of asthma, hypertension and obesity in children living in Pittsburgh's inner-city. Up to three years No
Secondary The secondary outcome of this study is to determine the impact of various educational interventions on child and caregiver knowledge of asthma. A pre and post asthma knowledge test will be given to children and caregivers prior to and after participation in the educational session conducted at each asthma camp. A paired sample t-test was used for comparison of pre and post knowledge tests and a p value of less than 0.05 will be considered to indicate a statistically significant difference. up to three years No
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