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
About this trial
This is an interventional prevention trial for Acute Kidney Injury
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
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
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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