The main reason for this research study is to learn about how adults with congenital heart disease (CHD) learn and think about the world around them. We know that children with CHD sometimes struggle in school and have trouble paying attention or interacting with friends. But, we do not know if these challenges extend into adulthood.
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The goal is to understand how adults with congenital heart disease learn and think. We hope to have 500 people from 13 hospitals in the United States and Canada in this study.
Males or females aged 18 to 30 years who have moderate or severe CHD.
The study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study.
These are the things that will happen during the study if you choose to participate:
If you qualify for this study, it is one visit that will last about two hours.
You may not benefit from taking part in this research study. However, when we finish the study, we hope to know more about how to improve the care of people with CHD.
The questionnaires you complete will be reviewed by a neuropsychologist. If the neuropsychologist thinks you may have challenges with learning, depression or anxiety, the study team will let you know and make a referral for further evaluation.
There is no known direct benefit from providing a sample for the biobank. However, the sample you provide may help researchers learn more about the link between genetics and long-term outcomes for children and adults with CHD and other conditions.
Questionnaires: You may find it inconvenient to complete the questionnaires. We will offer you plenty of time to answer the questions. Research staff will be available for support.
You may be asked questions that make you uncomfortable or cause you to remember situations that were upsetting to you. You do not need to answer any questions that you do not wish to answer. You can stop at any time. If you want to talk to someone about your feelings, let the study team know.
Blood (or Saliva) Samples: There is a small risk of bruising (a black or blue mark), feeling lightheaded or dizzy, fainting, infection, or a small amount of bleeding when having blood drawn. There are no known risks to providing a saliva sample.
Genetic Testing: There is a risk of discovering potentially abnormal genetic changes in your DNA of unclear clinical significance. There is also a chance that you may feel anxious about the possibility of carrying an abnormal gene in your DNA that may affect your health or that might be passed on to your children.
Biobanking: Your blood (or saliva) sample will be sent to the PHN biobank with a code so that researchers at the biobank and future researchers will not be able to directly identify you.
Confidentiality: There is a very small risk of loss of confidentiality of medical information; however, we have taken all possible steps to minimize this risk.
There will be no extra costs to you if you are in this study. Your insurance will not be billed for any research-related activity or test.
If referrals are made based on answers to the questionnaires or repeat genetic testing and genetic counseling is recommended, you/your insurance will be responsible for those costs. If your insurance company will not pay for repeat genetic testing and/or genetic counseling, the study will pay for them.