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

NCT ID: NCT04403633

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Receiving Educational Tool

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

Group Type EXPERIMENTAL

mobile health educational tool

Intervention Type OTHER

Interactive educational tool delivered on iPad

Receiving Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mobile health educational tool

Interactive educational tool delivered on iPad

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clarissa J Diamantidis, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Rasheed Gbadegesin, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna Williams

Role: CONTACT

919-684-4246

Facility Contacts

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Anna Williams

Role: primary

919-684-4246

Other Identifiers

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1R38HL143612-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00104197

Identifier Type: -

Identifier Source: org_study_id

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