Mobile App for Nephrotic Syndrome Management

Recruiting at 2 trial locations

Overseen By Margret Kamel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests UrApp, a mobile app that helps families manage nephrotic syndrome in children by tracking urine tests and medication. It targets caregivers of children who struggle with disease management. The app uses the phone's camera to read urine tests, reminds caregivers to check urine, tracks results, and alerts doctors if needed.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment UrApp for nephrotic syndrome management?

Research shows that information technology-based interventions, like mobile apps, can significantly improve self-management in chronic kidney disease patients, which suggests that UrApp might help patients manage nephrotic syndrome more effectively by supporting medication adherence and monitoring. ^{1 2 3 4 5}

Is the mobile app for nephrotic syndrome management safe for humans?

The research does not provide specific safety data for the mobile app itself, but emphasizes the importance of effective and safe digital apps for managing chronic conditions like nephrotic syndrome. ^{4 5 6 7 8}

What makes the UrApp treatment unique for managing nephrotic syndrome?

UrApp is a novel mobile application designed specifically for managing childhood nephrotic syndrome by supporting home urine protein monitoring, which is crucial for disease management. Unlike traditional treatments, it offers a user-friendly, expert-designed tool for vigilant self-monitoring and management of the condition. ^{1 4 9 10 11}

Research Team

Chia-shi Wang, MD, MS

Principal Investigator

Emory University

Eligibility Criteria

This trial is for caregivers of children aged 1-17 newly diagnosed with steroid-sensitive nephrotic syndrome, a chronic kidney disease. Participants must have internet access, be proficient in English, and the child should respond to steroids within 4 weeks. It's not for those caring for kids who've had a kidney transplant or have secondary causes like lupus.

Inclusion Criteria

Access to internet/wireless fidelity (Wi-Fi) in the home

I care for a child diagnosed with nephrotic syndrome less than 42 days ago.

Caregiver proficiency with the English language

Exclusion Criteria

I am a caregiver for a child who has had a kidney transplant.

I am a caregiver for a child with severe kidney disease.

My child has a kidney condition related to another illness like lupus.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the UrApp or standard of care and followed for one year

12 months

Regular follow-ups as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Standard of Care
• UrApp

Trial Overview The study tests if UrApp, a mobile app designed to help manage nephrotic syndrome in children, improves self-management and health outcomes compared to standard care alone. Caregivers will either use UrApp or follow usual care without the app over one year.

Participant Groups

Group I: UrApp Experimental Treatment 2 Interventions

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

Group II: Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

A study involving 36 participants, including children with chronic kidney disease (CKD), their parents, and healthcare professionals, identified key gaps in current online health information, highlighting the need for a more engaging and age-appropriate digital care-management app.

Participants emphasized that a tailored app could help children with CKD better explain their condition, adhere to treatment plans, and reduce feelings of isolation, suggesting that such an app could significantly improve their overall care and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Desirable Components for a Customized, Home-Based, Digital Care-Management App for Children and Young People With Long-Term, Chronic Conditions: A Qualitative Exploration. Nightingale, R., Hall, A., Gelder, C., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile Apps for the Care Management of Chronic Kidney and End-Stage Renal Diseases: Systematic Search in App Stores and Evaluation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Features and Effects of Information Technology-Based Interventions to Improve Self-Management in Chronic Kidney Disease Patients: a Systematic Review of the Literature. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of nephrotic syndrome in children and controlled trials. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Text Messaging for Disease Monitoring in Childhood Nephrotic Syndrome. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Childhood Nephrotic Syndrome Management and Outcome: A Single Center Retrospective Analysis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Quality Improvement Initiative to Reduce Admissions for Nephrotic Syndrome Relapse in Pediatric Patients. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Determinants of medication adherence in childhood nephrotic syndrome and associations of adherence with clinical outcomes. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Desirable Components for a Customized, Home-Based, Digital Care-Management App for Children and Young People With Long-Term, Chronic Conditions: A Qualitative Exploration. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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). [2021]

10. England pubmed.ncbi.nlm.nih.gov

Development of a novel mobile application to detect urine protein for nephrotic syndrome disease monitoring. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Mobile health apps for systemic lupus erythematosus and lupus nephritis: a critical appraisal. [2022]