Children, Teens and Adults 10 to 21 Needed for Lupus Screening Tool Research Study
What is the purpose of this study?
The purpose of this research study is to find out if a computer based test can be used to find out early if children with systematic lupus erythematosus are having changes in their thinking skills. If this can be done, we may be able to use the information to better treat children with lupus.
Who can participate?
Children, teenagers and adults 10 to 21 years old diagnosed with systematic lupus erythematosus may be eligible to participate.
What is involved?
You and your child will be asked to take a computer-based test every six months for up to three years (or seven study visits), which will occur at the same time as your rheumatology clinic visits.
A detailed list of procedures will be provided to you, as the participant, or parents or guardians interested in knowing more about this study. Here are some of the procedures:
You and your child will be asked to:
• Provide background and medical history information
• Complete a physical exam
• Review current medications
• Review lupus symptoms and complete a questionnaire on lupus activity
• Take a computer test to evaluate thinking skills
Parents or legal guardians will be asked to fill out a form about their state of health, school performance and mood.
What are the benefits?
You or your child will not receive a direct medical benefit. However, the information gained from this study may help patients with systematic lupus erythematosus in the future.
Will I get all the facts about the study?
You, as a participant or parent interested in having their child participate, will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What are the risks and discomforts of the study?
There are no physical risks associated with this study. Other possible discomforts or risks will be discussed with you, as the participant, or parents or guardians interested in learning more about the study.
Do participants receive pay, compensation or reimbursement?
There is no compensation for this study, however you or your child will be told about any new information learned from this study or other studies that may affect your health, welfare or willingness to stay in the study. Also, tests and procedures done specifically for the study will be paid for by the study.
Who should I contact for more information?
Hermine Brunner, MD
Division of Rheumatology
Cincinnati Children’s Hospital Medical Center