Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interview.
- Who it may be relevant to
- Registry conditions: Fluid Overload, Glomerulosclerosis, Focal Segmental, Edema, Membranous Nephropathy. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Preparing a Clinical Outcomes Assessment Set for Nephrotic Syndrome
Overview
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.
Detailed 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.
Interventions
- Behavioral Interview
Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.
Primary outcome measures
- Patient Reported Impact of Fluid Overload on symptoms and functioning [Time frame: Interviews are 60 minutes]
- Observer Reported Impact of Fluid Overload on symptoms and functioning [Time frame: Interviews are 60 minutes]
Eligibility criteria
Criteria for the Observer Reported Outcomes (ObsRO) cohort of the study:
Inclusion criteria
- 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.
Exclusion criteria
1\. Index case with dialysis dependence throughout the 3-month pre-enrollment period
Criteria for the Patient Reported Outcomes (PRO) cohort of the study:
Inclusion criteria
- ≥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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT05505500 · HUM00208148 · 5UG3FD007308-02