跳至主要内容
临床试验/NCT02741895
NCT02741895已完成不适用

Using Wearable Biosensors to Monitor Ambulation After Major Surgery: Optimizing Efficiency of Postoperative Recovery

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Number of steps

研究概览

简要总结

This study will evaluate whether information on postoperative ambulation from Fitbits can improve surgeons' ability to monitor ambulation and identify patients at risk for prolonged length of stay, 30-day readmissions, and discharge to transitional care after major surgery.

详细描述

After the patient is awake and alert after surgery, a study team member will place the Fitbit device on participants' wrists. Investigators will then monitor daily steps taken and active minutes for the duration of hospitalization, with the option to discontinue if clinically required or requested by the patient or provider. Investigators will record the wearable biosensor number and subject study number on a secure spreadsheet.

To supplement Fitbit data, a research coordinator will collect clinical data from chart review of the electronic health record (age, gender, race/ethnicity, body mass index, comorbid health conditions), and enter the data into a secure spreadsheet.

Physicians will also be participating in the study by providing data on estimated daily ambulation, using a standard formatted scale. Surgeons currently assess daily ambulation in the medical record, but assessments are not uniform, which precludes meaningful comparisons between providers. Investigators will therefore ask physicians to record daily estimates of ambulatory status according to standardized terms that are commonly used in the medical record (nonambulatory; out of bed to chair; out of bed to ambulate (QD, BID, TID); and ambulating ad lib). Investigators will also collect information on daily ambulation orders as entered by the provider team as part of routine practice. This information will be ascertained by chart review and entered into the secure spreadsheet along with the additional patient data.

The Fitbit device has a battery life of approximately 7 days, so investigators will plan to recharge and download information every 5 days.

At the time of discharge, a study team member will remove the device and download the information from the device to a secure spreadsheet. The wearable biosensor will be reset at that time and the information will be erased from its memory. Investigators will also clean the wearable biosensors with disinfectant used for durable medical equipment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 18 years of age or older
  • Undergoing robotic cystectomy, open colectomy, abdominal hysterectomy, esophagectomy, lung lobectomy, gastric bypass, or hip replacement
  • Able to provide informed consent

排除标准

  • Unable to provide consent
  • Not undergoing procedure of interest
  • Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
  • Use of walker, cancer, or wheelchair at baseline
  • Presence of physical limitations on walking (i.e. amputation)
  • Usual place of residence is skilled nursing facility
  • Cognitive inability to follow directions to maintain biosensor in place
  • Unable to place biosensor on patient's wrist

结局指标

主要结局

Number of steps

时间窗: Through study completion, on average 1 week

Number of steps per day during hospitalization, per Fitbit data.

Length of stay

时间窗: Through study completion, on average 1 week

Days from admission (end time of surgery) until discharge from hospital.

Location of disposition

时间窗: Through study completion, on average 1 week

Home, Rehab Facility, or Skilled Nursing Facility

Physician daily assessment of ambulatory status

时间窗: Through study completion, on average 1 week

Physician daily assessment of ambulatory status

Active minutes

时间窗: Through study completion, on average 1 week

Active minutes per day during hospitalization, per Fitbit data.

30-day readmission

时间窗: 30 days post discharge

Presence or absence of readmission to hospital or ER visit within 30 days of discharge.

次要结局

未报告次要终点

研究者

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

Timothy J. Daskivich

Assistant Professor, Urology Academic Practice

Cedars-Sinai Medical Center

研究点 (1)

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