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临床试验/NCT03435549
NCT03435549已完成不适用

Automated Hovering for Joint Replacement Surgery

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年2月7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
300
试验地点
1
主要终点
Discharged to home

研究概览

简要总结

This will evaluate the effectiveness of automated hovering to encourage patients to be discharged to home after hip or knee replacement surgery. Automated hovering includes monitoring of physical activity with an activity monitor, tracking of pain scores, daily feedback and motivational messages, social influence, and connection to clinicians as needed.

详细描述

The goal of this study is to test the approach of automated hovering to encourage patients to be discharged to home safely after lower extremity joint replacement surgery (LEJR). The investigators will target those patients undergoing hip or knee replacement surgery at a large urban hospital system at two different sites. The investigators aim is to increase the number of patients that are discharged to home, by providing patients with a physical activity pedometer, daily pain score tracking through bi-directional text messaging, milestone and nudge messaging for recovery, social influence, and connection to clinicians as needed for 6 weeks after surgery. Eligible participants are age 18-85, with a Risk Assessment and Prediction Tool (RAPT) score of 6-8 and are scheduled to undergo lower-extremity joint replacement surgery. Participants will be randomized 1:1 to usual care (Arm 1) and intervention (Arms 2a and 2b). After enrollment with the monitoring device, participants in the intervention group will be randomized 1:1 to Arm 2a (remote monitoring) or Arm 2b (remote monitoring + goal-setting and social support). Both intervention arms will receive the intervention for 6 weeks post-surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligibility Criteria: University of Pennsylvania Health System (UPHS) patients between the ages of 18-85 with a Risk Assessment and Prediction Tool (RAPT) of 6-8 and scheduled to undergo primary lower-extremity joint replacement surgery.

排除标准

  • •Patients will be excluded if they do not meet all of the inclusion criteria, or if they have bilateral or revision surgery, dementia, end stage renal disease, cirrhosis, metastatic cancer, non- English speaker, or other physical impairment (ex. amputation)

研究组 & 干预措施

Arm 2a: Remote monitoring

Experimental

If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery

干预措施: Remote monitoring (Behavioral)

Arm 1: Control Arm (Usual care)

No Intervention

If Patient is randomized to Arm 1, no contact will occur, patient will receive standard and routine clinical care

Arm 2b: Remote monitoring plus goal setting and social support

Experimental

If Patient is randomized to Arm 2b, they will receive a remote monitoring plus social support and nudge messaging for 6 weeks post-surgery

干预措施: Remote monitoring plus goal setting and social support (Behavioral)

结局指标

主要结局

Discharged to home

时间窗: Day of discharge through study completion at 6 weeks

% of patients discharged to home

Step increase

时间窗: 6 weeks post discharge

% of step increase as measured by activity tracker

次要结局

  • Days spent at home(6 weeks post discharge)
  • Timed Up and Go (TUG) score(6 weeks post discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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