跳至主要内容
临床试验/NCT03706963
NCT03706963终止不适用

Remote Telemonitoring to Improve Prehabilitation and Surgical Outcomes of Patients Undergoing Elective Abdominal Surgery

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2019年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
169
试验地点
1
主要终点
Effectiveness of the study intervention during the preoperative period to increase patients compliance with prehabilitation goals as measured by average steps per day

研究概览

简要总结

There is data confirming that simple tests of physical capability, such as the timed "get-up-and-go" test and the 6-minute walk test, correlate with surgical outcomes. It is reasonable to assume that preoperative telemonitoring, which allows for the tracking of more variables over a wider range of activities, could provide a significantly more accurate picture of a patient's physical fitness than a short one-time test performed in the clinic setting.

Almost half of the patients who are readmitted at Washington University are readmitted for less than 4 days. The readmitted patients usually present with sepsis, are treated with antibiotics and percutaneous drainage, and are discharged home relatively quickly. Earlier identification of these patients, prior to the development of sepsis, would reduce the risks to the patient and allow for outpatient management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •Scheduled to undergo elective abdominal surgery
  • •At least 18 years of age
  • •Able to understand and willing to sign an IRB-approved informed consent document

排除标准

  • •Doesn't have access to smartphone

研究组 & 干预措施

Phone Call

Experimental
  • Patients will be provided with a Fitbit wristband & assistance to set up on smart phone
  • Preoperative baseline data (activity, sleep, heartrate) will be collected for at least 14 days until the day prior to surgery
  • The group will receive a phone call 7 days into their preoperative period to identify barriers, provide available resources, & encourage continuation of prehabilitation activities
  • The physician extender will talk with the patient to identify barriers to prehabilitation activities that the patient may have experienced during the first 7 days of activity tracking & provide recommendations & resources to overcome those barriers when possible. The physician extender will encourage the patient to continue prehabilitation activities until the day of operation to meet goals. Following surgery, we will analyze Fitbit data to determine if the intervention had an impact on the patient's prehabilitation activity with the non-intervened patient group used as a control

干预措施: Phone Call (Other)

No Phone Call

No Intervention
  • Eligible patients will be provided with a Fitbit wristband & assistance to set up on smart phone
  • Preoperative baseline data (activity, sleep, heartrate) will be collected for at least 14 days until the day prior to surgery

结局指标

主要结局

Effectiveness of the study intervention during the preoperative period to increase patients compliance with prehabilitation goals as measured by average steps per day

时间窗: Baseline through 30 days after surgery discharge (approximately 45 days)

Patient compliance of telemonitoring with activity trackers as measured by percentage of time the patient is wearing the device properly

时间窗: Baseline through 30 days after surgery discharge (approximately 45 days)

-The number of heart rate data points that are collected per day is used as a proxy for determining the amount of time the patient is wearing the device properly.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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