- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692080
Implementation of an Asthma Program to Improve Asthma Identification and Education in Children
August 5, 2013 updated by: Duquesne University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
231
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15282
- Duquesne University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Two screenings will be held prior to each camp, at two separate locations, for a total of six screenings per year.
Screenings will be held at different locations throughout the city of Pittsburgh in an effort to increase identification and recruitment for subsequent camps.
All children will be invited to participate in screenings, regardless of participation in the study.
All children, ages 5-17 years, will be included in our study pending informed consent and assent.
Camps will take place three times each year.
All children will be invited to participate in camps, regardless of participation in the study.
All children, ages 5-17 years will be included in our study pending informed consent and assent.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Asthma Screenings and Camps
Children, ages 5-17 years who participate in one of the asthma screenings or camps are eligible to participate in this study.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome of this study is to document the prevalence of asthma, hypertension and obesity in children living in Pittsburgh's inner-city.
Time Frame: Up to three years
|
Up to three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary outcome of this study is to determine the impact of various educational interventions on child and caregiver knowledge of asthma.
Time Frame: up to three years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer P Elliott, PharmD, Duquesne University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 7, 2012
First Submitted That Met QC Criteria
September 21, 2012
First Posted (Estimate)
September 25, 2012
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 5, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU Protocol #10-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Addpharma Inc.Completed
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
Clinical Trials on Asthma education
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompleted
-
National Institute of Nursing Research (NINR)National Institutes of Health (NIH)Completed
-
Icahn School of Medicine at Mount SinaiCompletedPTSD | AsthmaUnited States
-
Hospital for Special Surgery, New YorkNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University Hospital Bispebjerg and FrederiksbergRecruiting
-
University of MiamiHealth Foundation of South Florida; Ounce of Prevention Fund; The Early Childhood...Completed
-
University of CalgaryCompleted
-
Ain Shams UniversityRecruitingThe Frequency of ER Visits in Asthmatic ChildrenEgypt
-
Missouri Breaks Industries Research, Inc.Sanford ResearchCompleted
-
Universidade Federal do Rio Grande do NorteCompleted