AsthmaNCT01692080
Implementation of an Asthma Program to Improve Asthma Identification and Education in Children
An observational study of Asthma and Hypertension, run by Duquesne University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Hypertension, Obesity
- What is being tested?
- Asthma education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children, ages 5- 17 years attending the asthma camps and screenings.
Who cannot join
- Children younger than 5 years of age and adults 18 years of age and older.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Asthma, Hypertension, Obesity
- Being tested
- Asthma education
- Medical subject headings
- Asthma, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma educationBehavioural
Also called asthma knowledge intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Asthma education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is to document the prevalence of asthma, hypertension and obesity in children living in Pittsburgh's inner-city.
Measured: Up to three years
Secondary outcomes (1)
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.
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Sponsor
- Investigators
- Jennifer P Elliott, PharmD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692080
- Sponsor's protocol ID
- DU Protocol #10-11
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Asthma Program to Improve Asthma Identification and Education in Children
- ClinicalTrials.gov ID
- NCT01692080
- Acronym / sponsor ID
- DU Protocol #10-11
- Conditions
- Asthma, Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Screenings and Camps | – | Behavioral: Asthma educationChildren, ages 5-17 years who participate in one of the asthma screenings or camps are eligible to participate in this study. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children, ages 5- 17 years attending the asthma camps and screenings.
Key exclusion criteria (1 listed)
- Children younger than 5 years of age and adults 18 years of age and older.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma educationAlso: asthma knowledge interventionTwo 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. | Behavioural | Asthma Screenings and Camps |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer P Elliott, PharmD principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Hypertension, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.