Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome
University of Michigan
Summary
Researchers from the University of Michigan and Northwestern University are studying people's experiences with swelling caused by Nephrotic Syndrome. Interviews with patients (child and adult) and parents of young children will be conducted. The information collected from the interviews will be used to develop a survey to use when testing new medications for Nephrotic Syndrome. Please consider participating in a 1-hour long interview with the Prepare-NS research study to discuss children and adults experiences with swelling.
Description
This registration includes concept elicitation, analysis and creation of complementary survey measures focused on edema/fluid overload of nephrotic syndrome. The measures to be developed include an Observer Reported Outcome (ObsRO) and Patient Reported Outcome (PRO). The ObsRO and PRO substudies are Institutional Review Board (IRB) approved at release. The researcher's goal is to produce core outcome sets of patient-rated and observer reported Fluid Overload (edema) measures that can be applied across the fluid overload severity continuum, fit to help drug development in this area.
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study: Inclusion Criteria: 1. Parents/guardians must be able to read and understand English; 2. Parents/guardians must be caring for a child (ages 2-11.999) with a medically documented diagnosis of idiopathic (primary) Nephrotic Syndrome (NS) or primary or monogenic NS associated kidney disease. Populations with Primary NS Conditions: Focal segmental glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin M (IgM) Nephropathy, Membranous Nephropathy (MN), and childhood - onset nephrotic syndrome not biopsied; 3.…
Interventions
- BehavioralInterview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Location
- University of MichiganAnn Arbor, Michigan