Clinical trial NCT04379921: Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
Official title: Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spine Disease
Spine Degeneration
Spinal Stenosis
Surgery
Spine Fusion
Keywords: Spine Surgery
Apple Watch
Objective Tracking of Spine Surgery Outcomes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2020-05-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* English-speaking.
* Undergoing elective spine surgery by attending physicians at Stanford University.
* Own iPhone

Exclusion Criteria:

* Patients with spine trauma, tumors, or infection.

Primary outcomes:
measure: Correlation between Objective Patient Measures (Steps, Distance Travelled, etc from Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI, VAS)
timeFrame: 2-6 weeks pre-operatively
measure: Correlation between Objective Patient Measures (Steps, Distance Travelled, etc from Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI, VAS)
timeFrame: 4-6 weeks post-operatively
measure: Correlation between Objective Patient Measures (Steps, Distance Travelled, etc from Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI, VAS)
timeFrame: 3 months post-operatively
measure: Correlation between Objective Patient Measures (Steps, Distance Travelled, etc from Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI, VAS)
timeFrame: 6 months post-operatively
measure: Correlation between Objective Patient Measures (Steps, Distance Travelled, etc from Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI, VAS)
timeFrame: 12 months post-operatively
measure: Change in Objective Outcome Measures (Steps, Distance Travelled, etc from Apple Watch) Before and After Surgery
timeFrame: 2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively
measure: Patient Compliance with Wearing Apple Watch
timeFrame: 2-6 weeks pre-operatively
measure: Patient Compliance with Wearing Apple Watch
timeFrame: 4-6 weeks post-operatively
measure: Patient Compliance with Wearing Apple Watch
timeFrame: 3 months post-operatively
measure: Patient Compliance with Wearing Apple Watch
timeFrame: 6 months post-operatively
measure: Patient Compliance with Wearing Apple Watch
timeFrame: 12 months post-operatively
measure: Patient Satisfaction with their Spine Care
timeFrame: 4-6 weeks post-operatively
measure: Patient Satisfaction with their Spine Care
timeFrame: 3 months post-operatively
measure: Patient Satisfaction with their Spine Care
timeFrame: 6 months post-operatively
measure: Patient Satisfaction with their Spine Care
timeFrame: 12 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Department of Neurosurgery at Stanford University
name: Corinna Zygourakis, MD
role: PRINCIPAL_INVESTIGATOR
References:
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