Trials / Recruiting
RecruitingNCT05505500
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Fluid Overload
- Glomerulosclerosis, Focal Segmental
- Edema
- Membranous Nephropathy
- Minimal Change Disease
- Minimal Change Nephrotic Syndrome
- IgM Nephropathy
- Nephrotic Syndrome
- Glomerular Disease
- Nephrotic Syndrome, Minimal Change
- Nephrotic Syndrome in Children
- Nephrotic Syndrome With Edema (Diagnosis)
- FSGS
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Interview | Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools. |
Timeline
- Start date
- 2022-04-18
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
- First posted
- 2022-08-17
- Last updated
- 2025-12-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05505500. Inclusion in this directory is not an endorsement.