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Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI)

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth tool
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

mHealth Tool

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Patient Safety-Related Knowledge (Patient safety risk awareness)
mHealth tool and how knowledge changes pre/post intervention
Change in Patient Safety Behavior and Risk awareness
Survey assessing patient safety behavior and risk awareness

Secondary Outcome Measures

User Satisfaction
Satisfaction of mHealth tool

Full Information

First Posted
April 11, 2017
Last Updated
December 12, 2018
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03114592
Brief Title
Understanding the Role of Patient Behavior Change in Improving AKI Outcomes
Acronym
Change AKI
Official Title
Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Acute kidney injury (AKI) is an increasingly common complication of acute hospitalizations. Hospital-related AKI, commonly caused by hemodynamic changes or contrast exposure, carries a threat of adverse outcomes that persists following hospital discharge, with an independent and graded association with long-term mortality. It is estimated that, approximately 13% of individuals with acute coronary syndrome (ACS) will develop some degree of AKI during their hospitalization. Survivors of AKI consume significantly greater health resources than the general population, and suffer exceedingly poor renal outcomes, including persistent loss of kidney function, progression to end stage renal disease (ESRD), and increased risk of recurrent AKI. It is estimated that 25% of individuals with an AKI-related hospitalization will be readmitted with recurrent AKI within 12 months of discharge, highlighting a critical need to address ongoing AKI risk once the acute hospitalization is complete. Patient-centered educational interventions that intensify awareness of potentially hazardous situations may reduce AKI recurrence. For example, commonly prescribed therapies such as diuretics or ACE inhibitors may threaten the renal safety of individuals at high risk of recurrent AKI if taken when significantly volume deplete, such as during an acute gastroenteritis, and in most cases should be held until one can eat and drink normally; Nonsteroidal Anti-inflammatory Drugs (NSAIDs) may exacerbate AKI risk if taken in combination with diuretics or ACE inhibitors even when volume replete and should be completely avoided. Tailored educational curricula surrounding these and other topics pertinent to AKI survivors may reduce recurrent hospitalizations and lower healthcare costs. In the absence of a patient centered outpatient approach to AKI education, the development of effective and sustainable AKI prevention strategies remains unlikely. Our long-term goal is to develop patient-centered educational materials to reduce AKI recurrence. We hypothesize that a tailored educational curriculum will improve patient awareness of potential hazards and reduce AKI recurrence among hospital-based AKI survivors. Therefore, our overall objective for this proposal is to pilot test and evaluate the feasibility of a patient-centered mobile health (mHealth) educational curriculum for hospitalized AKI survivors at Duke Medical Center. Aim 1: To test the feasibility and acceptance of a mHealth patient safety curriculum in hospitalized AKI survivors. Hypothesis 1: Patient safety risk awareness at 1 month will be higher in the educational intervention arm than the usual care arm. Aim 2: To determine if a mHealth educational curriculum improves patient safety behaviors in AKI survivors. Hypothesis 2: High-risk safety behaviors will be reduced at 1 month in AKI survivors receiving the educational intervention, but not in the usual care arm.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Arm Title
mHealth Tool
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
mHealth tool
Intervention Description
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").
Primary Outcome Measure Information:
Title
Change in Patient Safety-Related Knowledge (Patient safety risk awareness)
Description
mHealth tool and how knowledge changes pre/post intervention
Time Frame
Baseline, 1 month
Title
Change in Patient Safety Behavior and Risk awareness
Description
Survey assessing patient safety behavior and risk awareness
Time Frame
Baseline, 1 month
Secondary Outcome Measure Information:
Title
User Satisfaction
Description
Satisfaction of mHealth tool
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Legal blindness or deafness Pregnant Cognitive impairment that limits ability to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarissa J Diamantidis, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We are not sharing IPD

Learn more about this trial

Understanding the Role of Patient Behavior Change in Improving AKI Outcomes

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