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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
255
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.
Stanford University Hospital
Palo Alto, California, United States
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
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.
Time frame: 2-6 weeks pre-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
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.
Time frame: 4-6 weeks post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
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.
Time frame: 6 weeks-3 months post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
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.
Time frame: 3-6 months post-operatively
Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI)
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.
Time frame: 6-12 months post-operatively
Change in Objective Outcome Measures: Number of Steps After Surgery
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).
Time frame: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery
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).
Time frame: 2-6 weeks pre-operatively; 4-6 weeks, 6 weeks-3 months, 3-6 months, and 6-12 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Time frame: 2-6 weeks pre-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Time frame: 4-6 weeks post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Time frame: 6 weeks-3 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Time frame: 3-6 months post-operatively
Patient Compliance With Wearing Apple Watch - Wear Time
Average hours wear time per day across the outcome measure time frame.
Time frame: 6-12 months post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 6 weeks post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 3 months post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 6 months post-operatively
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 12 months post-operatively
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