The STAR Study 
Study Purpose
The purpose of the STAR study is to look in detail at common air contaminants to see if they are related to increased asthma severity in children. This is an epidemiological study which means it looks at conditions that are associated with disease in a large group. The study will enroll 1500 asthmatic children from 42 towns in Connecticut. The study does not treat asthma nor does it involve any experimental tests or procedures. It is a study looking at existing air quality and whether or not the levels of air pollutants affect the severity of asthma.
The STAR study is funded by the National Institute of Environmental Health Sciences of the National Institutes of Health (NIH). NIH is a U.S. government agency that grants funds to researchers to study important public health issues. Thousands of grant applications are reviewed each year by independent scientists who evaluate the significance and quality of research proposals and determine which ones should be funded. Only a small percentage of proposed studies receive funding.
Eligibility Screening
To enter the study a family must have a child 5-10 years old with active asthma or wheezing problems. Additional eligibility requirements are as follow:
- The child must live in the same household at least five days per week
- The child must not have other serious lung problems, such as cystic fibrosis.
- The child must agree to have one blood sample drawn for allergy testing.
- The child’s parent or guardian must agree to complete telephone interviews and to place air monitors at different times during the twelve months of participation.
When you contact the study office, whether by mail, email, phone or fax, a member of the research team will telephone you as soon as possible to answer your questions and to complete a screening interview about your child. The screening interview takes about 3 minutes. If your child is eligible, you will be invited to participate in the study and we will schedule a home visit at a time convenient for you. The study design does not permit participation of more that one child from the same household.
Note: If more than one child in your family is eligible, we will invite the child with more severe asthma to participate.
Enrollment
At the home visit a research assistant explains all of the details of the study and obtains the consent of the parent/guardian and the assent of the child for participation. The child must be present at the time of the home visit to have blood drawn and to be weighed and measured. The research assistant interviews the parent/guardian about the child’s health history and family history of asthma, allergies and breathing problems. The interview also includes questions about environmental conditions in the home, such as what types of appliances are used, whether there is air-conditioning, whether there is smoking in the home and whether there are pets in the home. The research assistant will also ask about the child’s activities, transportation to school and school days missed due to asthma.
Environmental samples are taken at the home visit to test for allergens and mold, and air monitors are set up indoors and outdoors to measure air quality.
You will receive a calendar and some stickers to keep track of the days your child has symptoms or uses medications for asthma.
Environmental Sampling and Measurements
While in the home the research assistant takes following environmental samples and measurements.
- Dust to be tested for the presence of common allergens such as cat, dog and dust mites.
- Air particles to see whether mold spores are present.
- The geographic location of the home is recorded to calculate the distance from roads and highways and to estimate exposure to road vehicle traffic.
- Small air monitors are set up inside and outside the home to measure air quality for one month. Each air monitor is a small test tube (about 3” long) that is clipped to a stand about the size of an 8 ounce coffee cup. One is placed in the child’s bedroom, the other in the room where the child spends the most time when s/he is awake. The outdoor filter is attached to a funnel-shaped cover and can hang from a tree or a railing. The research assistant shows you how to remove the air filters and provides a mailing pouch to return them to the study office. The research assistant will call when it is time to take them down.
Follow-up Phone Calls and Measurements
After the home visit, there are five phone interviews and three additional air quality measurements. The first follow-up call is one month after the home visit. The next three calls are at three-month intervals. The following table gives an example of the follow-up schedule for a family if they entered the study on January 1. Please note that this is a sample schedule and the dates would be different depending on when your family enters the study. Enrollment for this study continues until the Summer of 2008.
| January 1 | Home visit |
| February 1 | Follow-up call to have you take down the air monitors and return them, and to ask about the child's symptoms and medication use during the past month |
| April 1 | We send you a new set of air monitors to set up, and a research assistant calls to confirm that you received them |
| May 1 | Follow-up call to have you take down the air monitors and ask about your child's symptoms and medication use during the past month |
| July 1 | We send you a new set of air monitors to set up and a research assistant calls to confirm that you have received them. |
| August 1 | Follow-up call to have you take down the air monitors and ask about your child’s symptoms and medication use during the past month. |
| October 1 | We send you a new set of air monitors to set up and a research assistant calls to confirm that you have received them. |
| November 1 | Follow-up call to have you take down the air monitors and ask about your child’s symptoms and medication use during the past month. |
| January 1 | Final phone interview to ask about your child’s symptoms and to update information about the child’s environmental exposures, activities, missed school, etc. |
Risks of Participation
There are no significant risks to study participants. There is a small risk that bruising may occur at the site of blood drawing. There is also a small risk of release of confidential information. We believe any risk of this type is extremely small because of the confidentiality safeguards we have in place.
Benefits
Results of the allergy testing and allergen measurements made in the home (dust samples and mold) will be provided to you. This information may be helpful in managing your child’s asthma. In addition, this study will provide significant public health information about the relationship of asthma severity and asthma development to environmental agents.
Economic Considerations
Allergy testing is provided free of charge. Families who participate in the study will receive a payment of $25 each time air-monitors are successfully returned to the research office and following the final phone interview, for a total of $125. At the home visit the asthmatic child will receive a small toy and a $15 gift card after completing the blood draw. If you move away from the study area during the year following your home visit, you will receive payments only for monitorings completed before the move.
Confidentiality
Any identifiable information that is obtained in connection with this study will remain confidential and will be disclosed only with your permission or as required by U.S. or State law. Examples of information that we are legally required to disclose include abuse of a child or elderly person, or certain reportable diseases.
In all records of the study you will be identified by a number and your name will be known only to the researchers. The connection of the code to your name will only be available to the investigators at Yale and will be kept secure at all times. Your name will not be used in any scientific reports of the study. All of the information you give will be kept confidential and used only for research purposes. Representatives from the Yale Human Investigation Committee may inspect study records during internal auditing procedures. However, these individuals are required to keep all information confidential.
Data from this study will be kept indefinitely because it remains valuable and informative for a long time and may be reanalyzed in the future in relationship to new information about asthma.
Voluntary Participation
Participation in this study is completely voluntary. If you choose to enroll you may withdraw at any time. If you choose not to participate it will not affect your relationship with any of the participating institutions in any way now or in the future. If you withdraw you may request that your child’s blood specimens be destroyed and we will instruct our laboratory to do that.
INTERESTED IN PARTICIPATING? PLEASE EMAIL US AT kids.asthma@yale.edu AND ONE OF OUR RESEARCHERS WILL CONTACT YOU ABOUT THE STUDY.
