UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)

NCT04075656 | Completed Results DMC

• 2 other identifiers: IRB001089121K23DK118189-01A1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Idiopathic Nephrotic Syndrome

Keywords

Pediatrics; mHealth; Behavioral intervention

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting Medication Adherence

  Adherence to medications is evaluated via caregiver survey with the validated 4-question Morisky, Green, and Levine (MGL) Adherence Scale. Response options are Yes (0) or No (1) and total scores range from 0 to 4 with higher scores indicating better medication adherence. Adherence will be defined as a score of ≥3 on the MGL scale.

  Baseline, Month 6, Month 12

• Number of Participants Reporting Adherence With Urine Monitoring

  Caregiver adherence with urine protein monitoring is assessed by asking caregivers on average how often they checked their child's urine for protein over the past month. Possible responses are "once a week", "2-4 times a week" or " 5-7 times a week." Adherence is defined as checking urine at least 2 times per week.

  Baseline, Month 6, Month 12

Secondary Outcomes (5)

• Caregiver Self-efficacy Score

  Baseline, Month 6, Month 12

• Patient-Reported Outcomes Measurement Information System - Pediatric Quality of Life Inventory (PedsQL) Score for Parents

  Baseline, Month 6, Month 12

• Patient-Reported Outcomes Measurement Information System - Pediatric Quality of Life Inventory (PedsQL) Score for Pediatric Patients

  Baseline, Month 6, Month 12

• Number Pediatric Patients With Delayed Detection of Relapses

  Month 6, Month 12

• Number of Hospitalizations Among Pediatric Patients

  Month 6, Month 12

Study Arms (2)

UrApp

EXPERIMENTAL

Participants randomized to this study arm will use the UrApp mobile application for one year, in addition to receiving the standard of care.

Behavioral: Standard of Care; Behavioral: UrApp

Standard of Care

ACTIVE COMPARATOR

Participants randomized to this study arm will use receive the standard of care for one year.

Behavioral: Standard of Care

Interventions

Standard of Care BEHAVIORAL

Participants will be provided a folder of educational material on NS, including general information on symptoms, treatments, and possible complications; healthy diet for children taking corticosteroids; and low sodium diet. Site research staff will demonstrate how to check urine for protein with test strips, and educate patients on the definitions of disease relapse and remission. Urine test strips and urine protein logs will be provided to ensure that each participant can check their urine daily for protein. Participants will be instructed to check their urine daily for protein and call their provider within 1 business day for relapses and remissions.

Standard of Care; UrApp

UrApp BEHAVIORAL

Caregivers/parents will download UrApp at the baseline visit. UrApp contains instructional videos to guide users. The telephone number of the patient's provider will be entered into UrApp and participants will be able to call their providers directly through UrApp. The email address of the Emory study staff will also be entered. UrApp will automatically e-mail test results to the research staff when elected by the users. Participants will be asked by study staff, and reminded by the app, to call their providers and send urine testing results to the study staff whenever there is a relapse or remission. When the study staff receives alerts of a relapse/remission via UrApp, the information will be communicated to the treating physician within 1 business day.

UrApp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Children's Healthcare of Altanta

Atlanta, Georgia, 30322, United States

Location

University of Minnesota Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Wang CS, Escoffery C, Patzer RE, McCracken C, Ross D, Rheault MN, Al-Uzri A, Greenbaum LA. A dual efficacy-implementation trial of a novel mobile application for childhood nephrotic syndrome management: the UrApp for childhood nephrotic syndrome management pilot study protocol (UrApp pilot study). BMC Nephrol. 2020 Apr 9;21(1):125. doi: 10.1186/s12882-020-01778-w.

  PMID: 32272901 DERIVED

MeSH Terms

Conditions

Nephrosis, Lipoid

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Chia-shi Wang, MD, MS
• Organization: Emory University

chia-shi.wang@emory.edu

404-727-5728

Study Officials

• Chia-shi Wang, MD, MS

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: September 17, 2019
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for sharing immediately following publication, with no end date.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposals should be directed to chia-shi.wang@emory.edu. To gain access, data requesters will need to sign a data access agreement.

Locations

US (3)