Mobile App for Nephrotic Syndrome Management

No longer recruiting at 2 trial locations

Overseen By Margret Kamel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Corticosteroids

Disqualifiers: End-stage kidney disease, Renal transplantation, Secondary nephrotic syndrome

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called UrApp, designed to help families manage nephrotic syndrome, a kidney condition often affecting children. The researchers aim to determine if UrApp can improve disease management and the health of the children involved. Participants will either use the app or continue their usual care routine (standard of care) for one year. The trial seeks caregivers of children diagnosed with steroid-sensitive nephrotic syndrome in the last six weeks who have internet access at home. As an unphased trial, it offers families the chance to contribute to innovative research that could enhance disease management.

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 prior data suggests that the UrApp is safe for nephrotic syndrome management?

Research shows that UrApp is a mobile app designed to help families manage childhood nephrotic syndrome. The app tracks urine tests and medication, aiming to improve home management of the condition. As a digital tool, UrApp doesn't carry the same safety concerns as medications. Sources report no negative effects from its use. It primarily serves as a learning and monitoring tool, indicating that users generally find it easy to use.

The sources do not reveal any specific safety issues with UrApp, suggesting it is likely safe for families managing nephrotic syndrome. However, participants should follow study guidelines and report any problems they encounter. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the UrApp because it offers a unique approach to managing nephrotic syndrome by integrating digital health technology with the standard of care. Unlike traditional treatment options, which typically involve medication and regular doctor visits, UrApp provides patients with a mobile app designed to help them track their symptoms and manage their condition more effectively at home. This innovative tool aims to enhance patient engagement and empower individuals to take a proactive role in their health management, potentially leading to better outcomes and improved quality of life.

What evidence suggests that UrApp is effective for nephrotic syndrome management?

Studies have shown that the UrApp mobile application holds promise for helping families manage childhood nephrotic syndrome. Research indicates that this app can track urine tests and medication more effectively. Early results from a small study suggested that the app improved how families monitor and manage the condition. In this trial, participants in one arm will use the UrApp mobile application alongside the standard of care. This is important because better management can lead to fewer relapses and complications. The app aims to simplify following the treatment plan, potentially improving children's health outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Chia-shi Wang, MD, MS

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7146890/

the UrApp for childhood nephrotic syndrome management ... The UrApp Pilot Study examines the efficacy of a novel app designed specifically for nephrotic syndrome. The protocol involves dual efficacy and ...

2. bmcmedinformdecismak.biomedcentral.com bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-019-0822-z

Development of a novel mobile application to detect urine ... We describe the development of a novel mobile application, UrApp – Nephrotic Syndrome Manager, to aid disease monitoring.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04075656?tab=history&a=7

Record History | ver. 7: 2024-09-25 | NCT04075656 UrApp is a mobile application designed to assist families with nephrotic syndrome management. This study will examine whether providing the children's ...

4. withpower.com withpower.com/trial/mobile-app-for-nephrotic-syndrome-management-7f157

Mobile App for Nephrotic Syndrome Management This trial tests UrApp, a mobile app that helps families manage nephrotic syndrome in children by tracking urine tests and medication.

5. researchgate.net researchgate.net/figure/Clinical-efficacy-and-feasibility-outcome-measures-in-the-UrApp-for-Childhood-Nephrotic_tbl1_340542093

Clinical efficacy and feasibility outcome measures in the ... Clinical efficacy and feasibility outcome measures in the UrApp for Childhood Nephrotic Syndrome Management Pilot Study. Source publication. Fig. 1 UrApp ...

6. ctv.veeva.com ctv.veeva.com/study/urapp-for-childhood-nephrotic-syndrome-management-incident-cohort

UrApp for Childhood Nephrotic Syndrome Management ... UrApp is a mobile application designed to assist families with nephrotic syndrome management. This study will examine whether providing the ...

7. mdpi.com mdpi.com/2076-3417/15/21/11433

Nephrotic Syndrome Assistance System for Pediatric ... [5] developed UrApp, a mobile application for managing childhood nephrotic syndrome. The app facilitates urine test analysis and provides educational ...