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临床试验/NCT03253549
NCT03253549已完成不适用

TecHnology Enabled Self-MAnagemenT - VIsion for Remote Automated Patient Monitoring and EmpoWerment Following Cardiac and VasculaR Surgery

McMaster University4 个研究点 分布在 2 个国家目标入组 572 人开始时间: 2018年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
572
试验地点
4
主要终点
Hospital Readmission Rate

研究概览

简要总结

The SMArTVIEW program evaluates the use of remote, automated monitoring in hospital and at home, on patients undergoing cardiac and major vascular surgery, to determine the effect on the 45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission). Half of participants will receive the SMArTVIEW intervention of increased monitoring, while the other half will receive standard care after surgery.

详细描述

SMArTVIEW is an eHealth-enabled service delivery program that combines remote automated monitoring, education, and self-management training. SMArTVIEW is a two-stage intervention program. Stage 1 supports seniors after cardiac or major vascular surgery in hospital on the surgical unit (post-ICU). Participants are assigned automated, cableless, vital sign monitoring devices that are worn during their entire stay on the surgical unit (blood pressure cuff, respiration pod, and oxygen saturation probe). Any signs of deterioration are sent via handheld device to the primary care nurse for early intervention.

With a view to seamless transition home, Stage 2 supports these individuals at home during the first 30 days of recovery. Participants are sent home with Bluetooth enabled monitoring equipment including a tablet, blood pressure cuff, thermometer, pulse oximeter and weight scale. From home, the tablet uploads patients' vital signs and measurements automatically and sends them, via secure cloud infrastructure, to the SMArTVIEW Nurse on the surgical ward back at the hospital. The tablet interface also prompts patients to respond to brief, easy to read, daily surveys in order to inform the nurse about their status. The tablet also supports secure daily video visits and daily interaction with the nurse for postoperative assessment and support, surgical wound photographs, as well as patient access to customized educational materials.

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
None

入排标准

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

入选标准

  • Age ≥ 60 years;
  • Patient has undergone major cardiac or vascular surgery and has been admitted post-op to the surgical floor;
  • Anticipated length of stay (LOS) on the surgical floor is ≥ 48 hours;
  • Patient has a negative Confusion Assessment Method (CAM) test result preceding, or within 12 hours of arriving on the surgical floor and is randomized within the first 24 hours after arriving on the ward;
  • Patient is able to provide consent autonomously.

排除标准

  • Patient is unable to communicate with research staff, complete surveys and questionnaires, or a telephone interview;
  • Patient has an intolerance/allergy to adhesive;
  • Patient unable to complete 30 days of at-home follow up due to current or planned relocation to nursing home or rehab facility; and
  • Patients with radial graft sites

结局指标

主要结局

Hospital Readmission Rate

时间窗: Readmission within 45 days post discharge.

45-day risk of a composite of hospital readmission and emergency department/urgent care centre visits (not requiring hospital admission).

次要结局

  • Process & Implementation(Through study completion. An average of 1 year.)
  • User Experience while on the SMArTVIEW Intervention compared to standard of care(45 days and 6 months post discharge.)
  • Econometrics(45 days and 6 months post discharge.)
  • Composite of Major Complications associated with Undetected Hemodynamic Compromise(45 day and 6 months post discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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