Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome
University of Michigan
150 participants
Apr 18, 2022
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:
- Parents/guardians must be able to read and understand English;
- 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;
- The child must have a current NS-associated edema
- The child must have native kidney function
- Parents/guardians must provide informed consent.
- ≥8 years of age
- Able to read and understand English
- Primary (idiopathic) kidney disease that causes NS or monogenic NS associated kidney disease.
- i. Populations with Primary Nephrotic Syndrome (NS) Conditions include: FSGS, MCD, IgM nephropathy, MN, and childhood - onset nephrotic syndrome not biopsied
- Current NS-associated edema
- Kidney function with most recent estimated Glomerular Filtration Rate (eGFR) \> 25 ml/min/1.73m2
- Informed Consent: For patients ≥8 to \<18 years of age: a parent or legal guardian provide informed consent and the patient must provide assent. Patients ≥18 years of age must provide informed consent.
Exclusion Criteria4
- \. Index case with dialysis dependence throughout the 3-month pre-enrollment period
- Criteria for the Patient Reported Outcomes (PRO) cohort of the study:
- Native kidney disease participant with dialysis dependence during the 3-month pre-enrollment period
- Co-existing significant chronic or severe acute health condition that has the potential to influence how the participant feels or functions as related to fluid overload in NS
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Interventions
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05505500