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

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ClinicalTrials.gov Identifier: NCT03114592
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Other: mHealth tool Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Understanding the Role of Patient Behavior Change in Improving AKI Outcomes (Change AKI Study)
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 27, 2018

Arm Intervention/treatment
No Intervention: Standard Care
  • 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
Experimental: mHealth Tool
  • 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
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 Measures :
  1. Change in Patient Safety-Related Knowledge (Patient safety risk awareness) [ Time Frame: Baseline, 1 month ]
    mHealth tool and how knowledge changes pre/post intervention

  2. Change in Patient Safety Behavior and Risk awareness [ Time Frame: Baseline, 1 month ]
    Survey assessing patient safety behavior and risk awareness


Secondary Outcome Measures :
  1. User Satisfaction [ Time Frame: 5 minutes ]
    Satisfaction of mHealth tool



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114592


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Clarissa J Diamantidis, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03114592     History of Changes
Other Study ID Numbers: Pro00080287
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are not sharing IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases