Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT05505500
Status
Recruiting
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Conditions

  • Edema
  • FSGS
  • Fluid Overload
  • Glomerular Disease
  • Glomerulosclerosis, Focal Segmental
  • IgM Nephropathy
  • Membranous Nephropathy
  • Minimal Change Disease
  • Minimal Change Nephrotic Syndrome
  • Nephrotic Syndrome
  • Nephrotic Syndrome With Edema (Diagnosis)
  • Nephrotic Syndrome in Children
  • Nephrotic Syndrome, Minimal Change

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Interview — BEHAVIORAL
    Concept Elicitation Interviews are used to create tools followed by Cognitive Debrief Interviews that are used to review created tools.

Study Details

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.

Key Dates

Start date
Apr 18, 2022
Status verified
Nov 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Parent/Guardian of child with Nephrotic Syndrome (NS)
    This group will help create the Observer Reported Outcome (ObsRO) tool.
  • Arm: Person with Nephrotic Syndrome (NS)
    This group will help create the Patient Reported Outcome (PRO) tool.

Primary Outcome Measure

Patient Reported Impact of Fluid Overload on symptoms and functioning [ Time Frame: Interviews are 60 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Ashley Rahimi
[email protected]
734-647-5446
Eloise Salmon, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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