N/A
N=58
UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)
Idiopathic Nephrotic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04075656 ↗Enrolled (actual)
58
Serious AEs
24.1%
Results posted
Nov 2025
Primary outcome: Primary: Number of Participants Reporting Medication Adherence — 25; 21; 19; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard of Care (Behavioral); UrApp (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Medication Adherence |
25; 21; 19; 18; 15; 16 | — |
| PRIMARY Number of Participants Reporting Adherence With Urine Monitoring |
21; 18; 19; 18; 14; 14 | — |
| SECONDARY Caregiver Self-efficacy Score |
8.97; 9.35; 9.65; 9.42; 9.21; 9.49 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Pediatric Quality of Life Inventory (PedsQL) Score for Parents |
83; 85; 86; 84; 88; 76 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System - Pediatric Quality of Life Inventory (PedsQL) Score for Pediatric Patients |
91; 83; 89; 84; 94; 81 | — |
| SECONDARY Number Pediatric Patients With Delayed Detection of Relapses |
2; 7; 1; 4 | — |
| SECONDARY Number of Hospitalizations Among Pediatric Patients |
3; 7; 4; 10 | — |
Summary
Idiopathic nephrotic syndrome is one of the most common chronic kidney diseases in children. Patients suffer from frequent disease relapses and complications. Self-management is difficult for families and nonadherence is common, with adverse effects on the children's health. UrApp is a mobile application designed to assist families with nephrotic syndrome management. This study will examine whether providing the children's caregivers (or adolescent patients) with UrApp improves self-management and disease outcomes. This study will include 60 caregivers of children with newly diagnosed nephrotic syndrome. Participants will be randomized 1:1 to UrApp or standard of care and followed for 1 year.
Eligibility Criteria
Inclusion Criteria
- Caregivers of patients ages 1-17 with steroid sensitive nephrotic syndrome (clinical diagnosis with edema, nephrotic range proteinuria [urine protein to creatinine ratio >2 mg/mg, or ≥ 300 mg/dL or ≥ 3+ protein on urine dipstick], and hypoalbuminemia ≤ 2.5 g/dL; resolution of proteinuria [negative/trace protein on urine dipstick] within 4 weeks of corticosteroid treatment)
- Caregivers of pediatric patients with steroid sensitive nephrotic syndrome diagnosed within 42 days at the time of enrollment
- Access to internet/wireless fidelity (Wi-Fi) in the home
- Caregiver proficiency with the English language
Exclusion Criteria
- Caregivers of pediatric patients with end-stage kidney disease
- Caregivers of pediatric patients with renal transplantation
- Caregivers of pediatric patients with clinical or histologic evidence of secondary nephrotic syndrome (e.g., systemic lupus erythematosus)
Data sourced from ClinicalTrials.gov (NCT04075656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.