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Mobile App for Nephrotic Syndrome Management

N/A

Recruiting

Led By Chia-shi Wang, MD, MS

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 12

Awards & highlights

Study Summary

This trial will examine whether a mobile app designed to assist families with nephrotic syndrome management improves self-management and disease outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves using an application (UrApp) rather than medication, traditional side effects are not expected. However, there may be indirect consequences such as increased anxiety or reliance on the technology that could affect caregiver or patient well-being.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Medication Adherence

Change in Urine Monitoring Adherence

Secondary outcome measures

Change in Delayed Relapse Detection

Change in Hospitalizations

Change in Patient-Reported Outcomes Measurement Information System - Pediatric Quality of Life Inventory (PedsQL) Score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: UrAppExperimental Treatment2 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 CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,636 Total Patients Enrolled

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

2,359 Previous Clinical Trials

4,314,532 Total Patients Enrolled

Chia-shi Wang, MD, MSPrincipal Investigator - Emory University

Children's Healthcare of Atlanta at Egleston, Emory University Hospital

Media Library

Standard of Care Clinical Trial Eligibility Overview. Trial Name: NCT04075656 — N/A

Idiopathic Nephrotic Syndrome Research Study Groups: Standard of Care, UrApp

Idiopathic Nephrotic Syndrome Clinical Trial 2023: Standard of Care Highlights & Side Effects. Trial Name: NCT04075656 — N/A

Standard of Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT04075656 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has this trial been implemented across medical centers?

"Currently, the trial is being conducted at 4 separate sites in Portland, Atlanta, and Charleston as well as other nearby localities. To reduce transportation costs associated with participation, it is important to select the closest clinical location to you."

Answered by AI

What is the estimated sample size of participants in this research study?

"Affirmative, the information available on clinicaltrials.gov alludes to this trial actively recruiting patients; having first been posted on September 17th 2019 and most recently updated July 14th 2022. 4 sites have a total of 60 spots for participants in total."

Answered by AI

What are the chief aims of this research?

"This clinical trial's primary outcome measure is the change in urine monitoring adherence, while secondary objectives include assessing changes in patient-reported quality of life scores on a 5-point scale (PedsQL), self-efficacy for managing nephrotic syndrome using a 10-point scale, and delayed relapse detection by reviewing medical charts."

Answered by AI

Are there any available opportunities for people to participate in this trial?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this research is actively seeking participants, first posted on September 17th 2019 and most recently updated July 14th 2022. It requires 60 volunteers to be sourced from 4 separate medical sites."

Answered by AI

Recent research and studies

BMC NephrologyJournal

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)

Wang, Chia-shi, Cam Escoffery, Rachel E. Patzer, Courtney McCracken, Diana Ross, Michelle N. Rheault, Amira Al-Uzri, and Larry A. Greenbaum. 2020. “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 Nephrology. Springer Science and Business Media LLC. doi:10.1186/s12882-020-01778-w.

clinicaltrials.govStudy

UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)

Chia-shi Wang 2019. "UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04075656.

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