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RecruitingNCT04403633Updated Aug 7, 2026

A Study of Facilitators and Barriers to Improve Acute Kidney Injury in Children Through Mobile Health Intervention

An interventional study of mobile health educational tool in Acute Kidney Injury, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Duke University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study summary

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.

Read the detailed description

There is a need to provide better patient-centered care for acute kidney injury (AKI) in order to improve the adverse health outcomes associated with this common condition. This project involves thorough evaluation of patient and provider feedback on barriers and facilitators to pediatric AKI self-management in order to develop patient-centered pediatric AKI interventions. This will be done through interviews with families of patients diagnosed with AKI and providers who take care of these patients followed by integration of the results into modification of an existing educational tool previously used in adult patients. The study will take place in three parts with the first involving interviews, the second involving tool modification and usability testing, and the third involving pilot testing of the tool's impact.

02

Conditions studied

  • Acute Kidney Injury

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Keywords

  • AKI
  • Pediatric AKI
  • Acute Kidney Injury
03

In context

Acute Kidney Injury

1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.

This study's planned enrollment of 25 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 1 to 18 years
  • patients with diagnosis of AKI while hospitalized

Exclusion criteria

Exclusion Criteria:

  • legal blindness of deafness
  • cognitive impairment that limits ability to consent
  • non-English speaking
  • patient age greater than age 18 years, 11 months
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Receiving Educational Tool

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

    Other: mobile health educational tool

  • No intervention
    Receiving Usual Care

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

Interventions

  • Othermobile health educational tool

    Interactive educational tool delivered on iPad

06

What researchers measure

Primary outcomes

  1. Acute Kidney Injury (AKI) Knowledge Assessment score

    AKI Knowledge Assessment administered as pre-test prior to intervention and post-test one month after intervention. This assessment is scored with minimum value of 0% and maximum value of 100%. A higher score is a better outcome.

    Time frame: Baseline, 1 month

07

Study locations

1 of 1 sites recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04403633
Lead sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
May 27, 2020
Start date
Jun 1, 2020
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 7, 2026

Study contacts

Anna Williams
Contact
anna.e.williams@duke.edu
919-684-4246
Clarissa J Diamantidis, MD
principal investigator · Duke University
Rasheed Gbadegesin, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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