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临床试验/NCT04721288
NCT04721288尚未招募不适用

REmote moBile Outpatient mOnitoring in Transplant (Reboot) 2.0

University Health Network, Toronto0 个研究点目标入组 400 人开始时间: 2023年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
Unscheduled hospital admission or visit to emergency department or transplant clinic.

研究概览

简要总结

This study is designed to determine if an innovative mobile health intervention designed to improve patient-provider communication can reduce unscheduled hospitalizations, and visits to the emergency department and ambulatory clinic in adult heart, liver, and kidney transplant patients.

详细描述

Mobile health technologies such as smartphones and wearable devices can remotely monitor health. These technologies hold promise to improve health outcomes in a spectrum of patients by providing health care teams with better connectivity which may prompt more timely responses to questions and improvements to care.

The purpose of this study is to evaluate if solid organ transplant (SOT) recipients benefit from improved monitoring and removal of communication barriers as the most common reasons for readmission and mortality may be mitigated by clinical intervention. Additionally, medication adherence is critical in transplant patients to prevent graft rejection. We anticipate that remote monitoring will improve medication adherence/adjustments, and will allow for identification of early health issues, reducing preventable hospital readmissions. Thus, this study will determine if an innovative mobile health intervention, designed to improve patient-clinician communication, reduces unnecessary hospital readmission and visits to the emergency department and transplant clinic when utilized in addition to the standard of care telephone communication system. We will also incorporate clinical and continuous ambulatory physiologic data collected as part of the mobile health intervention to develop machine learning algorithms capable of identifying early indicators of adverse outcomes in adult heart, kidney, and liver transplant patients.

We hypothesize that: the delivery of personalized communication using a mobile health application will improve patient self-management resulting in a 50% reduction in preventable hospital readmission, and unscheduled visits to the emergency department and transplant clinic. With tailored communication through the mobile health application, we expect fewer standard of care phone messages for patients in the intervention group and patients with higher activity levels (average daily step-count) pre-transplantation will have lower index hospitalization length of stay. Finally, the large dataset collected from this study will allow novel machine learning-derived risk prediction models to more accurately predict adverse outcomes (e.g., organ rejection, infection, and death), compared to conventional regression models.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Solid organ (heart, liver, or kidney) transplant patients
  • The ability to use a smartphone
  • English speaking

排除标准

  • Poor health literacy (reading level less than grade 5)
  • Inability to follow instructions from the Reboot application
  • Transfer to a non-University Health Network Hospital for follow-up and management

结局指标

主要结局

Unscheduled hospital admission or visit to emergency department or transplant clinic.

时间窗: 1-month

A composite score of unscheduled hospital admission, visit to the emergency department or ambulatory transplant clinic (i.e., total number of visits) will be calculated for each group at the pre-specified time intervals. A central adjudication committee will assess each readmission and visit to determine if they constitute a study event.

次要结局

  • Easy Call interactions(1-month, 3-months, 12-months)
  • EuroQol-5 (EQ-5D) Dimension questionnaire(1-month, 3-months, 12-months)
  • Patient survival rate(12-months)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) tool(1-month, 3-months, 12-months)
  • Graft survival rate(12-months)
  • Index hospitalization length of stay(1-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heather Ross

Head, Division of Cardiology

University Health Network, Toronto

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