Spinal Stenosis, Spine Degeneration, Spine Disease, Spine Fusion, Surgery
Conditions
Keywords
Spine Surgery, Apple Watch, Objective Tracking of Spine Surgery Outcomes
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.
Interventions
DEVICEApple Watch and App
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.
Sponsors
Stryker Nordic
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | 2-6 weeks pre-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 | 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 | 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 | 2-6 weeks pre-operatively | Average hours wear time per day across the outcome measure time frame. |
| Patient Satisfaction With Their Spine Care | 6 weeks post-operatively | Reported as the number of participants, by response category. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Participants receive standard care. | 91 |
| Apple Watch and App Participants receive standard care, and an Apple Watch to record activity through the NeuroCoach App. | 96 |
| Total | 187 |
Baseline characteristics
| Characteristic | Control | Total | Apple Watch and App |
|---|---|---|---|
| Age, Continuous | 59.03 years STANDARD_DEVIATION 13.22 | 60.46 years STANDARD_DEVIATION 13.29 | 61.79 years STANDARD_DEVIATION 13.28 |
| Race/Ethnicity, Customized Asian | 7 Participants | 13 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race/Ethnicity, Customized Hispanic and Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic and Latino | 5 Participants | 12 Participants | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiians and Other Pacific Islanders | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 15 Participants | 8 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 67 Participants | 134 Participants | 67 Participants |
| Race/Ethnicity, Customized White and Hispanic | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized White and Native American | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 91 Participants | 187 Participants | 96 Participants |
| Sex: Female, Male Female | 50 Participants | 108 Participants | 58 Participants |
| Sex: Female, Male Male | 41 Participants | 79 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 96 |
| other Total, other adverse events | 0 / 91 | 0 / 96 |
| serious Total, serious adverse events | 0 / 91 | 0 / 96 |
Outcome results
Primary
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
Population: Participants with available data at the respective time point. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apple Watch and App | Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery | 4-6 weeks post-operatively | -792.29 meters per day | Standard Deviation 1586.98 |
| Apple Watch and App | Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery | 3 months post-operatively | 591.27 meters per day | Standard Deviation 1502.72 |
| Apple Watch and App | Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery | 6 months post-operatively | 915.26 meters per day | Standard Deviation 1584.86 |
| Apple Watch and App | Change in Objective Outcome Measures: Distance Traveled (Meters) After Surgery | 12 months post-operatively | 858.99 meters per day | Standard Deviation 1705.98 |
Primary
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
Population: Participants with available data at the respective time point. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apple Watch and App | Change in Objective Outcome Measures: Number of Steps After Surgery | 4-6 weeks post-operatively | -1166.04 steps per day | Standard Deviation 2272.07 |
| Apple Watch and App | Change in Objective Outcome Measures: Number of Steps After Surgery | 6 weeks-3 months post-operatively | 764.68 steps per day | Standard Deviation 2066.11 |
| Apple Watch and App | Change in Objective Outcome Measures: Number of Steps After Surgery | 3-6 months post-operatively | 1212.10 steps per day | Standard Deviation 2177.45 |
| Apple Watch and App | Change in Objective Outcome Measures: Number of Steps After Surgery | 6-12 months post-operatively | 1068.73 steps per day | Standard Deviation 2048.83 |
Primary
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
Population: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to SF-36 | 0.211745206 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to EQ-5D | 0.137757731 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to PROMIS | -0.028651640 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to NDI | -0.195235044 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to ODI | -0.130278276 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to SF-36 | 0.205169697 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to EQ-5D | 0.122267044 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to PROMIS | -0.004087870 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to NDI | -0.195274715 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to ODI | -0.102500089 correlation coefficient |
Comparison: Analysis of correlation: steps to SF-36p-value: 0.14778771Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to EQ-5Dp-value: 0.36288455Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to NDIp-value: 0.65291937Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to ODIp-value: 0.61429132Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to SF-36p-value: 0.1589642Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to EQ-5Dp-value: 0.39253325Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to PROMISp-value: 0.99526258Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to NDIp-value: 0.65291937Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to ODIp-value: 0.67694276Wilcoxon (Mann-Whitney)
Primary
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
Population: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to SF-36 | 0.237509597 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to EQ-5D | 0.254596876 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to PROMIS | -0.061318768 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to NDI | -0.026754947 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to ODI | -0.237678247 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to SF-36 | 0.251030049 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to EQ-5D | 0.249053662 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to PROMIS | -0.044081635 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to NDI | -0.047181840 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to ODI | -0.234325616 correlation coefficient |
Comparison: Analysis of correlation: steps to SF-36p-value: 0.0909144Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to EQ-5Dp-value: 0.12858419Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to NDIp-value: 0.9304017Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to ODIp-value: 0.38647114Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to SF-36p-value: 0.0909144Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to EQ-5Dp-value: 0.12858419Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to NDIp-value: 0.9304017Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to ODIp-value: 0.38647114Wilcoxon (Mann-Whitney)
Primary
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
Population: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to SF-36 | 0.093993286 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to EQ-5D | 0.144224016 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to PROMIS | -0.094520314 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to NDI | 0.055377523 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to ODI | -0.257180828 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to SF-36 | 0.058395557 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to EQ-5D | 0.153422291 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to PROMIS | -0.109789378 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to NDI | 0.027880729 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to ODI | -0.202307765 correlation coefficient |
Comparison: Analysis of correlation: steps to SF-36p-value: 0.52394318Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to EQ-5Dp-value: 0.37244637Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to NDIp-value: 0.9304017Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to ODIp-value: 0.38647114Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to SF-36p-value: 0.7155239Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to EQ-5Dp-value: 0.35456143Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to NDIp-value: 0.9304017Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to ODIp-value: 0.42512141Wilcoxon (Mann-Whitney)
Primary
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
Population: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to SF-36 | 0.299619225 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to EQ-5D | 0.313524073 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to PROMIS | -0.086753507 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to NDI | -0.239505761 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to ODI | -0.322504210 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to SF-36 | 0.293769111 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to EQ-5D | 0.308525815 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to PROMIS | -0.067371364 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to NDI | -0.234173267 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to ODI | -0.325285216 correlation coefficient |
Comparison: Analysis of correlation: steps to SF-36p-value: 0.06340316Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to EQ-5Dp-value: 0.08121447Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to NDIp-value: 0.59932922Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to ODIp-value: 0.3581397Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to SF-36p-value: 0.06340316Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to EQ-5Dp-value: 0.08121447Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to NDIp-value: 0.59932922Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to ODIp-value: 0.3581397Wilcoxon (Mann-Whitney)
Primary
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
Population: Participants with data for the respective time frame and patient-reported outcome. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to SF-36 | 0.160804476 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to EQ-5D | 0.170547163 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to PROMIS | 0.03133065 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to NDI | -0.287227624 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Steps to ODI | -0.245495419 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to SF-36 | 0.156072138 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to EQ-5D | 0.165543596 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to PROMIS | 0.047067760 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to NDI | -0.288155169 correlation coefficient |
| Apple Watch and App | Correlation Between Objective Patient Measures (Steps, Distance Travelled, From Apple Watch) and Patient-Reported Outcome Measures (SF-36, EQ-5D, PROMIS, NDI, ODI) | Distance traveled (meters) to ODI | -0.238599412 correlation coefficient |
Comparison: Analysis of correlation: steps to SF-36p-value: 0.26801155Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to EQ-5Dp-value: 0.27520264Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to NDIp-value: 0.5623012Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: steps to ODIp-value: 0.3581397Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to SF-36p-value: 0.26801155Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to EQ-5Dp-value: 0.08121447Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to PROMISp-value: 0.95547874Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to NDIp-value: 0.59932922Wilcoxon (Mann-Whitney)
Comparison: Analysis of correlation: distance (meters) to ODIp-value: 0.3581397Wilcoxon (Mann-Whitney)
Primary
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
Population: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apple Watch and App | Patient Compliance With Wearing Apple Watch - Wear Time | 14.26 hours per day | Standard Deviation 3.37 |
Primary
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
Population: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apple Watch and App | Patient Compliance With Wearing Apple Watch - Wear Time | 14.05 hours per day | Standard Deviation 3 |
Primary
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
Population: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apple Watch and App | Patient Compliance With Wearing Apple Watch - Wear Time | 14.47 hours per day | Standard Deviation 3.63 |
Primary
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
Population: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apple Watch and App | Patient Compliance With Wearing Apple Watch - Wear Time | 14.49 hours per day | Standard Deviation 3.3 |
Primary
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
Population: Participants with available data. This outcome was evaluated on the Apple Watch and App group only (the Control group was not assigned an Apple Watch).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apple Watch and App | Patient Compliance With Wearing Apple Watch - Wear Time | 14.15 hours per day | Standard Deviation 3.62 |
Primary
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 6 weeks post-operatively
Population: Participants who completed the survey at this time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 0 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 63 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 6 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 20 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 2 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 2 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 23 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 51 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 1 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 7 Participants |
Primary
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 3 months post-operatively
Population: Participants who completed the survey at this time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 17 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 4 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 4 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 0 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 49 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 0 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 39 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 19 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 4 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 4 Participants |
Primary
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 6 months post-operatively
Population: Participants who completed the survey at this time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 19 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 3 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 5 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 0 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 39 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 2 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 29 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 17 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 2 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 2 Participants |
Primary
Patient Satisfaction With Their Spine Care
Reported as the number of participants, by response category.
Time frame: 12 months post-operatively
Population: Participants who completed the survey at this time point
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 22 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 1 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 4 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 3 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 52 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Not at all satisfied | 4 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Extremely satisfied | 33 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Very satisfied | 17 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Somewhat satisfied | 13 Participants |
| Apple Watch and App | Patient Satisfaction With Their Spine Care | Neutral | 1 Participants |