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

Primary Purpose

Acute Kidney Injury

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mobile health educational tool

About this trial

This is an interventional health services research trial for Acute Kidney Injury focused on measuring AKI, Pediatric AKI, Acute Kidney Injury

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Receiving Educational Tool

Receiving Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04403633

First Posted

May 21, 2020

Last Updated

July 21, 2023

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04403633

Brief Title

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

Official Title

Improving Patient-Centered Care in Pediatric Acute Kidney Injury (Change Peds AKI)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

AKI, Pediatric AKI, Acute Kidney Injury

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Receiving Educational Tool

Arm Type

Experimental

Arm Description

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

Arm Title

Receiving Usual Care

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

mobile health educational tool

Intervention Description

Interactive educational tool delivered on iPad

Primary Outcome Measure Information:

Title

Acute Kidney Injury (AKI) Knowledge Assessment score

Description

Time Frame

Baseline, 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Williams

Phone

919-684-4246

anna.e.williams@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clarissa J Diamantidis, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rasheed Gbadegesin, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erin Burks

Phone

919-681-4374

erin.burks@duke.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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