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临床试验/NCT03114592
NCT03114592已完成不适用

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

Duke University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Change in Patient Safety-Related Knowledge (Patient safety risk awareness)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: mHealth tool (Other)

结局指标

主要结局

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

时间窗: Baseline, 1 month

mHealth tool and how knowledge changes pre/post intervention

Change in Patient Safety Behavior and Risk awareness

时间窗: Baseline, 1 month

Survey assessing patient safety behavior and risk awareness

次要结局

  • User Satisfaction(5 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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