Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

Study Overview
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Brief Summary
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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.

Official Title
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Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch

Conditions
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Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery, Spine Fusion

Intervention / Treatment
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* Device: Apple Watch and App


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will receive standard care. | |
| Experimental: Apple Watch and App<br>Participants will receive standard care, and an Apple Watch to record activity through the App. | Device: Apple Watch and App<br>* Participants in the Apple Watch and App arm will receive an Apple Watch and download an App (NeuroCoach). The Apple Watch and App are used for this study to record patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. Visual Analog Scale (VAS): Scores range from 0 to 100 mm. Higher scores indicate worse health outcomes. | 2-6 weeks pre-operatively | 
| 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) | 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. Visual Analog Scale (VAS): Scores range from 0 to 100 mm. Higher scores indicate worse health outcomes. | 4-6 weeks post-operatively | 
| 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) | 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. Visual Analog Scale (VAS): Scores range from 0 to 100 mm. Higher scores indicate worse health outcomes. | 3 months post-operatively | 
| 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) | 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. Visual Analog Scale (VAS): Scores range from 0 to 100 mm. Higher scores indicate worse health outcomes. | 6 months post-operatively | 
| 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) | 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. Visual Analog Scale (VAS): Scores range from 0 to 100 mm. Higher scores indicate worse health outcomes. | 12 months post-operatively | 
| Change in Objective Outcome Measures (Steps, Distance Travelled, etc from Apple Watch) Before and After Surgery |  | 2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively | 
| Patient Compliance with Wearing Apple Watch |  | 2-6 weeks pre-operatively | 
| Patient Compliance with Wearing Apple Watch |  | 4-6 weeks post-operatively | 
| Patient Compliance with Wearing Apple Watch |  | 3 months post-operatively | 
| Patient Compliance with Wearing Apple Watch |  | 6 months post-operatively | 
| Patient Compliance with Wearing Apple Watch |  | 12 months post-operatively | 
| Patient Satisfaction with their Spine Care |  | 4-6 weeks post-operatively | 
| Patient Satisfaction with their Spine Care |  | 3 months post-operatively | 
| Patient Satisfaction with their Spine Care |  | 6 months post-operatively | 
| Patient Satisfaction with their Spine Care |  | 12 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spine Surgery, Apple Watch, Objective Tracking of Spine Surgery Outcomes