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

Primary Purpose

Spine Disease, Spine Degeneration, Spinal Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple Watch and App
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spine Disease focused on measuring Spine Surgery, Apple Watch, Objective Tracking of Spine Surgery Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Apple Watch and App

Arm Description

Participants will receive standard care.

Participants will receive standard care, and an Apple Watch to record activity through the App.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Change in Objective Outcome Measures (Steps, Distance Travelled, etc from Apple Watch) Before and After Surgery
Patient Compliance with Wearing Apple Watch
Patient Compliance with Wearing Apple Watch
Patient Compliance with Wearing Apple Watch
Patient Compliance with Wearing Apple Watch
Patient Compliance with Wearing Apple Watch
Patient Satisfaction with their Spine Care
Patient Satisfaction with their Spine Care
Patient Satisfaction with their Spine Care
Patient Satisfaction with their Spine Care

Secondary Outcome Measures

Full Information

First Posted
April 30, 2020
Last Updated
April 11, 2023
Sponsor
Stanford University
Collaborators
Stryker Nordic
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1. Study Identification

Unique Protocol Identification Number
NCT04379921
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Stryker Nordic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery, Spine Fusion
Keywords
Spine Surgery, Apple Watch, Objective Tracking of Spine Surgery Outcomes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive standard care.
Arm Title
Apple Watch and App
Arm Type
Experimental
Arm Description
Participants will receive standard care, and an Apple Watch to record activity through the App.
Intervention Type
Device
Intervention Name(s)
Apple Watch and App
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
2-6 weeks pre-operatively
Title
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)
Description
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.
Time Frame
4-6 weeks post-operatively
Title
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)
Description
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.
Time Frame
3 months post-operatively
Title
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)
Description
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.
Time Frame
6 months post-operatively
Title
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)
Description
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.
Time Frame
12 months post-operatively
Title
Change in Objective Outcome Measures (Steps, Distance Travelled, etc from Apple Watch) Before and After Surgery
Time Frame
2-6 weeks pre-operatively; 4-6 weeks, 3 months, 6 months, and 12 months post-operatively
Title
Patient Compliance with Wearing Apple Watch
Time Frame
2-6 weeks pre-operatively
Title
Patient Compliance with Wearing Apple Watch
Time Frame
4-6 weeks post-operatively
Title
Patient Compliance with Wearing Apple Watch
Time Frame
3 months post-operatively
Title
Patient Compliance with Wearing Apple Watch
Time Frame
6 months post-operatively
Title
Patient Compliance with Wearing Apple Watch
Time Frame
12 months post-operatively
Title
Patient Satisfaction with their Spine Care
Time Frame
4-6 weeks post-operatively
Title
Patient Satisfaction with their Spine Care
Time Frame
3 months post-operatively
Title
Patient Satisfaction with their Spine Care
Time Frame
6 months post-operatively
Title
Patient Satisfaction with their Spine Care
Time Frame
12 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Tang, BA
Phone
8312779234
Email
metang@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinna Zygourakis, MD
Organizational Affiliation
Department of Neurosurgery at Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Tang, BA
Phone
831-277-9234
Email
metang@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28660102
Citation
Bernstein DN, Brodell D, Li Y, Rubery PT, Mesfin A. Impact of the Economic Downturn on Elective Lumbar Spine Surgery in the United States: A National Trend Analysis, 2003 to 2013. Global Spine J. 2017 May;7(3):213-219. doi: 10.1177/2192568217694151. Epub 2017 Apr 6.
Results Reference
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Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979-1990. Spine (Phila Pa 1976). 1994 May 15;19(10):1117-23; discussion 1123-4. doi: 10.1097/00007632-199405001-00003.
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PubMed Identifier
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Citation
O'Lynnger TM, Zuckerman SL, Morone PJ, Dewan MC, Vasquez-Castellanos RA, Cheng JS. Trends for Spine Surgery for the Elderly: Implications for Access to Healthcare in North America. Neurosurgery. 2015 Oct;77 Suppl 4:S136-41. doi: 10.1227/NEU.0000000000000945.
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Parker SL, Chotai S, Devin CJ, Tetreault L, Mroz TE, Brodke DS, Fehlings MG, McGirt MJ. Bending the Cost Curve-Establishing Value in Spine Surgery. Neurosurgery. 2017 Mar 1;80(3S):S61-S69. doi: 10.1093/neuros/nyw081.
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Epstein NE. A review article on the benefits of early mobilization following spinal surgery and other medical/surgical procedures. Surg Neurol Int. 2014 Apr 16;5(Suppl 3):S66-73. doi: 10.4103/2152-7806.130674. eCollection 2014.
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Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.
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Lu TC, Fu CM, Ma MH, Fang CC, Turner AM. Healthcare Applications of Smart Watches. A Systematic Review. Appl Clin Inform. 2016 Sep 14;7(3):850-69. doi: 10.4338/ACI-2016-03-R-0042.
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Links:
URL
https://acl.gov/sites/default/files/Aging%20and%20Disability%20in%20America/2017OlderAmericansProfile.pdf
Description
2017 Profile of Older Americans
URL
https://www.strategyanalytics.com/access-services/devices/wearables/market-data/report-detail/global-smartwatch-vendor-market-share-by-region-q4-2018
Description
Global Smartwatch Vendor Market Share

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

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