NCT03114592

Brief Summary

This study is looking to improve the safety of patients with acute kidney injury via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

December 13, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

April 11, 2017

Last Update Submit

December 12, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Patient Safety-Related Knowledge (Patient safety risk awareness)

    mHealth tool and how knowledge changes pre/post intervention

    Baseline, 1 month

  • Change in Patient Safety Behavior and Risk awareness

    Survey assessing patient safety behavior and risk awareness

    Baseline, 1 month

Secondary Outcomes (1)

  • User Satisfaction

    5 minutes

Study Arms (2)

Standard Care

NO INTERVENTION

* Complete a survey asking about kidney function and participant demographics. * Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge

mHealth Tool

EXPERIMENTAL

* Complete a survey asking about kidney function and participant demographics. * Review a 15-20 minute educational tool on a tablet about kidney health * Receive a one-month follow-up call (one month after hospital discharge date) and complete a phone survey about patient kidney function after discharge

Other: mHealth tool

Interventions

The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing the post-hospital discharge stories of two hypothetical AKI survivors. opics of emphasis included NSAID risk awareness and avoidance of volume depletion when ill ("Sick Day Protocol").

mHealth Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acute kidney injury as diagnosed by renal care team
  • On medical or surgical services
  • Over 18 year of age
  • Ability to read and speak English

You may not qualify if:

  • Legal blindness or deafness
  • Pregnant
  • Cognitive impairment that limits ability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Clarissa J Diamantidis, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 14, 2017

Study Start

June 16, 2017

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

December 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

We are not sharing IPD

Locations