A multisite, observational study to examine the effects of childhood-onset SLE on cognitive functions over time, using the pedANAM tool for cognitive and behavioral assessments
Stacey Tarvin, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
PRIMARY OBJECTIVES:
The study's main objective is to track and analyze the long-term outcomes of neuropsychiatric systemic lupus erythematosus (NPSLE) in children and how it affects their cognitive functions over time. This includes monitoring changes in cognitive performance using the pedANAM tool, which gives a detailed understanding of the cognitive trajectories in these patients.
SECONDARY OBJECTIVES:
The secondary objective aims to compare children with NPSLE to those without NPSLE, focusing on various health metrics such as Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Systemic lupus international collaborating Clinics damage index (SLICC), medication adherence, and quality of life. This comparison will help identify specific challenges faced by children with NPSLE and determine the potential areas for intervention.
Another secondary objective is to identify factors that predict cognitive impairment in children with SLE. By analyzing data from a large population, the study aims to determine which clinical, demographic or treatment related factors are associated with a high risk of cognitive decline.
Detailed description of study
What will happen during the study?
After obtaining informed consent, essential data elements including demographics, disease phenotype, disease activity, and medication exposures will be obtained from subjects at enrollment. Data for the Registry will also be collected from the subject and/or parent/legal guardian, the site Principal Investigator (PI) or designee, and the medical record and/or EHR.
After enrollment, patients will be clinically evaluated as standard of care dictates, typically 2 to 6 times yearly.
Follow-up (recurring) data will be collected directly from the subject (via paper, application or web-based questionnaires) and from the subject’s medical record with the goal of entering data approximately every 6 months.
Data may be collected more frequently in certain circumstances, for example, if the physician is treating a subject according to a consensus treatment plan. Data will also be collected each time treatment with a DMARD (biologic or non- biologic) is initiated.
Data may be obtained from the subject/legal guardian via telephone or other electronic means if subject is unable to visit the CARRA Registry site, or between scheduled visits. All appropriate protections will be employed for non-site subject contact.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Rheumatic disease, Juvenile idiopathic arthritis, JIA, Childhood-onset systemic lupus erythematosus, cSLE, Riley
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Age: 21 years or below
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Gender: All
INCLUSION CRITERIA
1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19
years for all other rheumatic diseases (see appendix A). JIA subjects with disease
onset after the 16 th birthday may be enrolled as part of a consensus treatment plan
provided they meet all other eligibility criteria.
2. Subject (and/or parent/legal guardian when required) is able to provide written
informed consent and willing to comply with study procedures.
3. Subject and/or parent/legal guardian is willing to be contacted in the future by study
staff.
EXCLUSION CRIERIA
1. Greater than 21 years of age at the time of enrollment.
