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

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04403633
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
25
Enrollment
1
Location
2
Arms
27
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: mobile health educational tool
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Patient-Centered Care in Pediatric Acute Kidney Injury (Change Peds AKI)
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
Interactive educational tool delivered on iPad
No Intervention: Receiving Usual Care

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

Outcome Measures

Primary Outcome Measures

  1. Acute Kidney Injury (AKI) Knowledge Assessment score [Baseline, 1 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Clarissa J Diamantidis, MD, Duke University
  • Principal Investigator: Rasheed Gbadegesin, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04403633
Other Study ID Numbers:
  • Pro00104197
  • 1R38HL143612-01
First Posted:
May 27, 2020
Last Update Posted:
Jul 21, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
AKI
Pediatric AKI
Acute Kidney Injury
Additional relevant MeSH terms:
Acute Kidney Injury
Wounds and Injuries

Study Results

No Results Posted as of Jul 21, 2022