What does a typical study visit look like?
Before you come into a clinical center for a study visit, you will speak with a clinical research coordinator who will ask you a series of questions to asses your eligibility for the study. At this time, you may ask questions about the study and get more information on what is required of you. If you meet all the eligibility requirements, you will schedule an appointment with us to come into the clinical center and complete a study visit. You will have one to two visits for this study which will take a total of about four hours. However, if any of the tests need to be repeated because they were not completed or not done well enough, we may call you back for another visit. Below is a list with a description of each test that we will perform or the information that we will ask you to give us about your health. If you have questions on these tests, please ask your clinical study coordinator when you call to schedule a study visit.
1. You will be asked to complete a screening questionnaire to determine if you qualify for the study. This questionnaire asks about your lung and selected other medical conditions, lung surgery, smoking history, previous studies, recent surgery and hospitalizations, heart conditions, and your age, race and ethnicity. Only non-Hispanic Caucasian (White) and non-Hispanic African-American subjects can participate in this study. If you do not qualify for the study, you will not have any additional procedures.
2. If you meet the inclusion criteria for the study you will be given several questionnaires that will ask about symptoms of lung disease, shortness of breath, family history, medical conditions, medications you are taking, and health-related quality of life. Some of these questions are taken from standardized commonly used questionnaires. You will be asked to complete the questionnaires by yourself or the study coordinator will ask you the questions either on the computer or using a paper questionnaire. It will take between 45 and 90 minutes to complete all the questionnaires in this study.
3. You will be asked to provide your address, home and cell phone numbers, and email address. We will also collect this contact information on two other people you know well including one close relative not living with you; we need this information in case you move or change your phone number. We will not give this information to anyone else. We will ask you the name and address of your primary physician and pulmonary (lung) doctor so we can send them some of the results of this study that may be of medical importance to you. We will also collect your social security number (but not the social security numbers of your friends/relatives); this will be used to check your vital status in case we can not reach you or one of the other people you gave us.
4. You will be asked if you are currently participating, expect to participate or have in the past participated in other research studies about lung disease. If you participated in other trials, we would like to obtain information about your results in the other studies to see if there is an association with those results and your genetic and other test results in the COPDGene study .
About 8 teaspoons (1 teaspoon is the same as 5 ml) of blood will be removed by putting a needle into a vein in your arm or the back of your hand. This is the standard method used to obtain blood for testing.
Breathing Test (Spirometry):
Spirometry is a breathing test that measures how much air you can blow out of your lungs and how fast you can blow out that air. You will be asked to forcefully blow into a lung testing machine. This test will be performed at least three times. After the test is done, you will be given an inhaled medication (albuterol) to open up your air passages. Twenty to thirty minutes after that medication, you will do spirometry again to measure your lung function. You will also be asked to breathe in and out normally and then take a slow deep breath in several times. Before you are given albuterol, you will be asked some questions to assure your safety when you take this medication and have the six-minute walk test.
Physical Assessment :
Your blood pressure, height and weight will be obtained. A probe will be placed on your finger to measure your oxygen saturation and heart rate while you are resting and breathing room air. If you use oxygen, your oxygen will be removed for 10 minutes to check your oxygen level while you are breathing room air sitting and resting in a chair. If your oxygen level falls to 82% or less or if you become short of breath your oxygen will be replaced.
Six-Minute Walk Test:
You will be asked to walk for 6 minutes on a level surface to see how far you can go. If you use oxygen when you walk, you will use it for this test.
High Resolution Chest CT Scan :
You will have a chest CT scan. Before the CT scan, we will ask you about recent bronchodilator medication that you have taken. For the CT scan, you will lie on a table and the table will move through the middle of an x-ray machine that looks like a large round donut. You will be asked to lie quietly and take a deep breath in and hold it for the scan. Then you will be asked at the end of a normal breath to hold your breath for a second scan. The amount of radiation for the second scan is a quarter (25%) of the amount of radiation for the first scan. If you had a chest CT scan in the previous year and if that chest CT scan is of sufficient quality to measure the amount of emphysema you may have and measure the size of the air passages in your lungs, we may be able to use that chest CT scan; if so you will not have to have a new chest CT scan.
Women who are pregnant are not eligible for this study. If you are capable of being pregnant, you will have a urine pregnancy test before the chest CT scan to be sure you are not pregnant.
Medical Record Review (performed only if you have COPD):
The following test results will be obtained from your medical record if records are readily available: high resolution CT scan if done within the last year, pulmonary function tests including lung volumes and diffusing capacity, and oxygen level (arterial blood gas).
Follow-Up Contacts :
We will contact you by regular mail, email, newsletter or telephone up to four times a year for the next ten years. We will ask about your health and whether you have changed your address or phone numbers, and we will mail you a newsletter about lung disease and progress in the COPDGene Study. We may also contact you to invite you to participate in other research studies about lung disease in the next ten years. We plan to apply for additional funding in the future to follow you for a longer period of time. We will ask you if you want to be a part of future extensions of the COPDGene study.
You will be encouraged to tell your friends and spouse who have a history of cigarette smoking about this study. You will be asked to give a brochure to your friends and ask them to contact us to enroll in the study.
If you would like to schedule a study visit, please visit our Locations page to find a study site near you.