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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for children with acute kidney injury (AKI), a condition where the kidneys suddenly stop functioning properly. Researchers are testing a mobile health educational tool, a digital resource designed to help patients and families better understand and manage AKI. Participants will be divided into two groups: one will receive standard care, and the other will receive the educational tool alongside standard care. This trial may suit children aged 1 to 18 who have been diagnosed with AKI while in the hospital. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance patient education and management of AKI.

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.

What prior data suggests that this mobile health educational tool is safe for children with acute kidney injury?

Research has shown that mobile health tools for managing acute kidney injury (AKI) in children are generally safe. Designed to enhance education and care, these tools help children and their families manage AKI more effectively. Studies have found that this technology is usually well-tolerated.

Experts agree that digital health tools can significantly improve outcomes for children with AKI. They assist in educating healthcare providers and patients, which is essential for effective management of the condition. So far, no major reports of negative effects have emerged from using these educational tools. Overall, current evidence supports the safety of these tools for children with AKI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Educational Tool for acute kidney injury in children because it offers a fresh approach to managing this condition. Unlike conventional treatments that primarily focus on medical interventions, this tool leverages technology to educate and empower patients and their families. By providing easy access to critical information and self-care strategies, it aims to enhance understanding and engagement in the treatment process. This approach could lead to improved management of the condition by fostering proactive health behaviors and potentially reducing complications associated with acute kidney injury in children.

What evidence suggests that this mobile health educational tool is effective for acute kidney injury?

Research has shown that educational tools can improve health outcomes for children with acute kidney injury (AKI). A report from the Acute Disease Quality Initiative (ADQI) emphasized the importance of education and advocacy in enhancing results in pediatric AKI. This trial will compare two groups: one receiving usual care and another receiving a mobile health educational tool in addition to usual care. Although specific data on this mobile health tool is limited, the general idea is that better knowledge leads to better care and fewer complications. The goal is to ensure that children and their families understand AKI and manage it effectively. ^{1 2 5 6 7}

Who Is on the Research Team?

Clarissa J Diamantidis, MD

Principal Investigator

Duke University

Rasheed Gbadegesin, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04403633

NCT04403633 | A Study of Facilitators and Barriers to ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10817828/

Pediatric AKI in the real world: changing outcomes through ... Pediatric AKI in the real world: changing outcomes through education and advocacy—a report from the 26th Acute Disease Quality Initiative (ADQI) ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT04403633

A Study of Facilitators and Barriers to Improve Acute ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022347619316002

Acute Kidney Injury in Children Based on Electronic Alerts To define the incidence and outcome of acute kidney injury (AKI) in pediatrics using data collected from a national electronic alert system.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04403633/a-study-of-facilitators-and-barriers-to-improve-acute-kidney-injury-in-children-through-mobile-health-intervention

A Study of Facilitators and Barriers to Improve Acute ... The purpose of this study is to improve patient-centered care for acute kidney injury (AKI) in order to decrease the adverse health outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11285755/

Digital health and acute kidney injury: consensus report of the ... Here, we provide recommendations from the Acute Disease Quality Initiative consensus meeting, which involved experts in adult and paediatric nephrology, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949813925000291

Acute Kidney Injury Provider and Survivor Education Acute kidney injury (AKI) is associated with an increased risk of adverse health outcomes, but the proportion of patients receiving optimal care is low.