Mobile Health Intervention for Acute Kidney Injury in Children

Overseen By Anna Williams

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Legal blindness, deafness, cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to improve patient-centered care for acute kidney injury (AKI) in order to decrease the adverse health outcomes associated with this common condition.

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.

Is the Mobile Health Intervention for Acute Kidney Injury in Children safe?

The research articles do not provide specific safety data for the Mobile Health Intervention for Acute Kidney Injury in Children, but they discuss the use of digital applications and telemedicine for improving patient safety in related conditions, suggesting that such technologies can be safely used to enhance care. ^{1 2 3 4 5}

How is the mobile health intervention for acute kidney injury in children different from other treatments?

This mobile health intervention is unique because it uses a digital app to support the management of acute kidney injury in children, offering personalized, condition-specific guidance for day-to-day care, which is not typically available with standard treatments. ^{6 7 8 9 10}

Research Team

Rasheed Gbadegesin, MD

Principal Investigator

Duke University

Clarissa J Diamantidis, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for children aged 1 to 18 years who have been diagnosed with acute kidney injury (AKI) while in the hospital. It's not suitable for kids over 18 years and 11 months, those with cognitive impairments that prevent consent, non-English speakers, or those who are legally blind or deaf.

Inclusion Criteria

I was diagnosed with acute kidney injury while in the hospital.

Exclusion Criteria

I am legally blind or deaf.

Non-English speaking

I have difficulty understanding or making decisions due to cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interviews

Interviews with families of patients diagnosed with AKI and providers to gather feedback on barriers and facilitators to pediatric AKI self-management

4 weeks

Tool Modification and Usability Testing

Modification of an existing educational tool based on interview feedback and usability testing

4 weeks

Pilot Testing

Pilot testing of the educational tool's impact on patient-centered care for pediatric AKI

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Mobile Health Educational Tool

Trial Overview The study is testing a mobile health educational tool designed to improve care for children with AKI. The goal is to reduce negative health outcomes by providing patient-centered education through this technology.

Participant Groups

Group I: Receiving Educational Tool Experimental Treatment 1 Intervention

Patients in this arm will receive the educational tool after the pretest in addition to usual care.

Group II: Receiving Usual Care Active Control 1 Intervention

Patients in this arm will receive usual care after the pretest.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a 1-year study involving 182 outpatients with advanced chronic kidney disease (CKD), the eKidneyCare app significantly reduced medication discrepancies compared to the MyMedRec app, indicating better medication management.

eKidneyCare not only lowered the total number of discrepancies but also reduced the severity of clinically relevant discrepancies, including those that could potentially cause serious harm, highlighting its effectiveness in improving medication safety for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Ong, SW., Jassal, SV., Porter, EC., et al.[2023]

Chronic kidney disease (CKD) patients face a high risk of adverse safety events due to factors like impaired kidney function and polypharmacy, which can lead to serious outcomes such as hospitalization and accelerated kidney function loss.

Telemedicine, particularly through interactive voice-response systems, offers a promising way for CKD patients to communicate safety-related issues to healthcare providers, although many patients face challenges in accessing these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. Weiner, S., Fink, JC.[2022]

In a study involving 2,818 pediatric patients, the use of AKI risk alerts significantly increased the rate of serum creatinine (SCr) testing in intensive care settings, with 69% of at-risk patients tested compared to 60% in the control group.

However, the alerts did not lead to any differences in AKI incidence or severity in either intensive care or ward settings, indicating that while screening improved, it did not change the outcomes of AKI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial. Van Driest, SL., Wang, L., McLemore, MF., et al.[2021]

In a usability study with 12 participants who had chronic kidney disease (CKD) or were family members, 22% of tasks resulted in critical errors, indicating challenges in navigating the Safe Kidney Care website effectively.

Despite some difficulties, participants expressed general satisfaction with the website's content, highlighting the need for web-based educational materials to accommodate varying levels of computer literacy among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of a CKD educational website targeted to patients and their family members. Diamantidis, CJ., Zuckerman, M., Fink, W., et al.[2021]

A quality improvement project in a pediatric hospital led to a 38% reduction in nephrotoxin exposure and a 64% decrease in acute kidney injury (AKI) rates among hospitalized children over a 43-month period, demonstrating the effectiveness of systematic monitoring.

The implementation of an Electronic Health Record screening process allowed for timely identification of at-risk patients, suggesting that similar strategies could be beneficial in both pediatric and adult hospital settings to prevent avoidable harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sustained quality improvement program reduces nephrotoxic medication-associated acute kidney injury. Goldstein, SL., Mottes, T., Simpson, K., et al.[2021]

Qualitative interviews with 26 children and young people revealed that a web-based application for managing chronic kidney disease should provide clear, accurate, and age-appropriate information to be effective.

Access to Wi-Fi and the ability to feel 'normal' were crucial factors; some participants preferred not to access care information outside of the hospital to maintain a sense of normalcy, highlighting the need for the application to balance health management with social integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children and young people's views on access to a web-based application to support personal management of long-term conditions: a qualitative study. Huby, K., Swallow, V., Smith, T., et al.[2022]

A review of 31 mobile health apps for kidney stone disease found that fluid management apps are generally of higher quality than dietary apps, scoring better in technical quality, usability, and clinical value.

While most fluid apps provide good privacy policies, only 36% allow users to consent to secondary data use, highlighting a potential privacy concern despite their effectiveness in managing kidney stone disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Evaluation of Smartphone Applications for the Medical Management of Nephrolithiasis. Winoker, JS., Koo, K., Huang, MM., et al.[2021]

In a study of 70 children and adolescents with severe diabetic ketoacidosis (DKA), protocol deviations were found in 82.9% of cases, leading to significant complications such as severe hypokalemia and hypoglycemia.

The development of a mobile application for DKA management showed promise in adhering to treatment protocols, potentially reducing errors and improving patient outcomes compared to standard management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Development and Validation of a Mobile Application for Guidance for Management of Severe Diabetic Ketoacidosis. Mendpara, H., Bajpai, A., Patel, R., et al.[2022]

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]

In a study of 367 children with chronic kidney disease (CKD), higher parental health literacy was linked to a nearly 30% longer time before CKD progressed to severe outcomes like dialysis or kidney transplant.

The study followed participants for an average of 3.7 years, indicating that improving parental health literacy could potentially lead to better health outcomes for children with CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental health literacy and progression of chronic kidney disease in children. Ricardo, AC., Pereira, LN., Betoko, A., et al.[2019]

References

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

Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. [2023]

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

Telemedicine to Promote Patient Safety: Use of Phone-Based Interactive Voice-Response System to Reduce Adverse Safety Events in Pre-dialysis CKD. [2022]

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

Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial. [2021]

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

Usability of a CKD educational website targeted to patients and their family members. [2021]

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

A sustained quality improvement program reduces nephrotoxic medication-associated acute kidney injury. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Children and young people's views on access to a web-based application to support personal management of long-term conditions: a qualitative study. [2022]

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

Systematic Evaluation of Smartphone Applications for the Medical Management of Nephrolithiasis. [2021]

8. India pubmed.ncbi.nlm.nih.gov

The Development and Validation of a Mobile Application for Guidance for Management of Severe Diabetic Ketoacidosis. [2022]

9. 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]

10. Germany pubmed.ncbi.nlm.nih.gov

Parental health literacy and progression of chronic kidney disease in children. [2019]