Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
研究概览
简要总结
One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization postoperatively. This study is the first prospective trial utilizing the Apple Watch to objectively track patients before and after elective spine surgery. The investigators hypothesize that the ability of patients to track their own activity and discuss with their surgeon objective mobilization goals will not only help patients achieve empowerment in their own care but also improve their overall satisfaction and self-reported outcomes after spine surgery.
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
- •English-speaking.
- •Undergoing elective spine surgery by attending physicians at Stanford University.
- •Own iPhone
排除标准
- •Patients with spine trauma, tumors, or infection.
结局指标
主要结局
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
时间窗: 6-12 months post-operatively
Steps and distance (meters) collected by Apple Watch were averaged across the outcome measure time frame. Survey scores were collected at the end of the outcome measure time frame. * Short Form-36 (SF-36): Scores range from 0 to 100. Higher scores indicate better health outcomes. * EuroQOL-5 Dimensional Questionnaire (EQ-5D): Scores range from 0 to 100. Higher scores indicate better health outcomes. * Patient-Reported Outcomes Measurement Information System (PROMIS): Scores range from 41 to 78.3. Higher scores indicate worse health outcomes. * Neck Disability Index (NDI): Scores range from 0 to 100. Higher scores indicate worse health outcomes. * Oswestry Disability Index (ODI): Scores range from 0 to 100. Higher scores indicate worse health outcomes.
Change in Objective Outcome Measures: Number of Steps After Surgery
时间窗: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Steps per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
时间窗: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Meters per day collected by Apple Watch were averaged across the respective outcome measure time frame. Change was calculated as the post-baseline value minus the baseline value (which was normalized to zero).
Patient Compliance With Wearing Apple Watch - Wear Time
时间窗: 6-12 months post-operatively
Average hours wear time per day across the outcome measure time frame.
Patient Satisfaction With Their Spine Care
时间窗: 12 months post-operatively
Reported as the number of participants, by response category.
次要结局
未报告次要终点
研究者
Corinna Zygourakis
Assistant Professor of Neurosurgery
Stanford University