Institutional Review Board, Hospital for Special Surgery
May 08, 2014
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
We will be recruiting 72 patients. Enrollment will occur in early 2104. Patients will be asked to complete study questionairres (45 minutes) on the date of enrollment and a one-time focus group session (2 hours) at a later date.
• Age 15 and older at the time of screening
• Diagnosis of SLE, self-reported by the patient and verified by chart review using ACR Criteria (4 of 11)
• Patient must be under the care of an HSS rheumatologist and have seen his/her rheumatologist at least once in the past 12 months
• Must own and report daily use of a smartphone or tablet, specifically with iOS or Android operating systems
• Must use apps (examples include Calendar, Notes, Photos, Reminders)
• Non-English speaking patients are not eligible to participate as per investigator’s assessment
• Unable to follow directions appropriately or participate effectively in a focus group
Alana B. Levine, MD