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NCT04403633 Clinical Trial

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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04403633
Other study ID # Pro00104197
Secondary ID 1R38HL143612-01
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date June 2024

Study information
Verified date January 2024
Source Duke University
Contact Anna Williams
Phone 919-684-4246
Email anna.e.williams@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• mobile health educational tool
Interactive educational tool delivered on iPad

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline, 1 month
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