AsthmaNCT01170676
Promoting Asthma Wellness in Rural Communities
A study testing Puff City GA and General Asthma Education in people with Asthma, run by Augusta University at 1 site in United States.
Trial summary
This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth: 1. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Puff City GA and General Asthma Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2014
- Phase
- Interventional
- 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 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- AA ethnicity
- in 9th - 11th grade of selected rural schools
- have an asthma diagnosis and/or asthma-like symptoms by screening eligible on the Lung Health Survey
- have access to a telephone or mobile phone
- being the parent of a student meeting the above criteria with whom the student resides the majority of the time.
Who cannot join
- Not meeting the above criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth:
- Improving adherence to asthma controller medication use;
- Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms;
- Improving inhaler technique;
- Smoking reduction or cessation in those who are smokers; and
- Avoidance of second-hand smoke exposure.
Read the detailed description
A randomized control trial across three southeastern rural high schools comparing a web-based tailored intervention (known as Puff City) to web-based traditional control education sites.
- Conditions
- Asthma
- Being tested
- Puff City GA, General Asthma Education
- Keywords
- asthma, smoking, teens
- Medical subject headings
- Asthma, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puff City GABehavioural
Also called Behavioral Puff City Ga.
Puff City GA focuses on three areas of health behavior: 1) adherence to controller medications; 2) immediate availability of rescue medication; 3)smoking cessation/reduction.
General Asthma EducationBehavioural
Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.
| Study group | Role | What they receive |
|---|---|---|
| Puff City GA | Experimental | Puff City is an NHLBI-funded (C. Joseph, PI; Henry Ford Health System, Detroit, MI), web-based intervention that targets three key asthma management issues in youth: 1) smoking reduction or cessation in those who are smokers, 2) improving adherence to asthma controller medication use, and 3) improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms. Puff City Ga. is a replication study in the rural southeastern United States that adds biological assessments in addition to self-report data. Receives: Behavioral: Puff City GA |
| General Asthma Education | Active comparator | Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management. Receives: Behavioral: General Asthma Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report
Measured: baseline, end of treatment, 6 months, 12 months
Secondary outcomes (1)
Change in exhaled nitric oxide and active and passive smoke exposure, measured by salivary cotinine.
Measured: baseline, end of treatment, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System, University of Michigan
- Responsible party
- Principal investigator, Martha Tingen, Augusta University
- Investigators
- Martha S Tingen, PhD, Principal investigator, Augusta UniversityDennis R Ownby, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170676
- Sponsor's protocol ID
- R01HL092412
- Status last verified
- Jan 2015
- First submitted
- 12 May 2010
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jordan DM, Bush JS, Ownby DR, Waller JL, Tingen MS. The impact of traditional literacy and education on health literacy in adolescents with asthma. J Asthma. 2019 Aug;56(8):882-890. doi: 10.1080/02770903.2018.1494191. Epub 2018 Sep 5.
PubMed 29984589
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Asthma Wellness in Rural Communities
- ClinicalTrials.gov ID
- NCT01170676
- Acronym / sponsor ID
- R01HL092412
- Conditions
- Asthma
- Keywords
- asthma, smoking, teens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Henry Ford Health System, University of Michigan
- Study start
- Aug 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Jul 2010 (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.
This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth:
- Improving adherence to asthma controller medication use;
- Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms;
- Improving inhaler technique;
- Smoking reduction or cessation in those who are smokers; and
- Avoidance of second-hand smoke exposure.
Detailed description
A randomized control trial across three southeastern rural high schools comparing a web-based tailored intervention (known as Puff City) to web-based traditional control education sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puff City GA | Experimental | Behavioral: Puff City GAPuff City is an NHLBI-funded (C. Joseph, PI; Henry Ford Health System, Detroit, MI), web-based intervention that targets three key asthma management issues in youth: 1) smoking reduction or cessation in those who are smokers, 2) improving adherence to asthma controller medication use, and 3) improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms. Puff City Ga. is a replication study in the rural southeastern United States that adds biological assessments in addition to self-report data. |
| General Asthma Education | Active comparator | Behavioral: General Asthma EducationStudents will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- AA ethnicity
- in 9th - 11th grade of selected rural schools
- have an asthma diagnosis and/or asthma-like symptoms by screening eligible on the Lung Health Survey
- have access to a telephone or mobile phone
- being the parent of a student meeting the above criteria with whom the student resides the majority of the time.
Key exclusion criteria (1 listed)
- Not meeting the above criteria.
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 |
|---|---|---|
| Puff City GAAlso: Behavioral Puff City Ga.Puff City GA focuses on three areas of health behavior: 1) adherence to controller medications; 2) immediate availability of rescue medication; 3)smoking cessation/reduction. | Behavioural | Puff City GA |
| General Asthma EducationStudents will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management. | Behavioural | General Asthma Education |
Primary outcome
Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report
Time frame: baseline, end of treatment, 6 months, 12 months
1 secondary outcome
Change in exhaled nitric oxide and active and passive smoke exposure, measured by salivary cotinine.
Time frame: baseline, end of treatment, 6 months, 12 months
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 2 Feb 2015.
- Derived from this study: PubMed 29984589Jordan DM, Bush JS, Ownby DR, Waller JL, Tingen MS. The impact of traditional literacy and education on health literacy in adolescents with asthma. J Asthma. 2019 Aug;56(8):882-890. doi: 10.1080/02770903.2018.1494191. Epub 2018 Sep 5.
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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.
Martha S Tingen, PhD principal investigator
Augusta University
Dennis R Ownby, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puff City GA and General Asthma Education in people with Asthma, run by Augusta 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 5 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 2 Feb 2015. 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?
Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report (time frame: baseline, end of treatment, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01170676, which also lists 1 linked publication.
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 2 Feb 2015.