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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379921
• Other study ID #: 52367
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Diseases
• Spinal Stenosis
• Spine Degeneration
• Spine Disease
• Spine Fusion
• Surgery

Intervention

Device:
• Apple 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.

Locations

Country	Name	City	State
United States	Stanford University Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Stryker Nordic

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Breteler MJ, Janssen JH, Spiering W, Kalkman CJ, van Solinge WW, Dohmen DA. Measuring Free-Living Physical Activity With Three Commercially Available Activity Monitors for Telemonitoring Purposes: Validation Study. JMIR Form Res. 2019 Apr 24;3(2):e11489. doi: 10.2196/11489. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Henriksen A, Haugen Mikalsen M, Woldaregay AZ, Muzny M, Hartvigsen G, Hopstock LA, Grimsgaard S. Using Fitness Trackers and Smartwatches to Measure Physical Activity in Research: Analysis of Consumer Wrist-Worn Wearables. J Med Internet Res. 2018 Mar 22;20(3):e110. doi: 10.2196/jmir.9157. — View Citation

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. — View Citation

Mobbs RJ, Phan K, Maharaj M, Rao PJ. Physical Activity Measured with Accelerometer and Self-Rated Disability in Lumbar Spine Surgery: A Prospective Study. Global Spine J. 2016 Aug;6(5):459-64. doi: 10.1055/s-0035-1565259. Epub 2015 Oct 13. — View 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. — View Citation

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. — View Citation

Phan K, Mobbs RJ. Long-Term Objective Physical Activity Measurements using a Wireless Accelerometer Following Minimally Invasive Transforaminal Interbody Fusion Surgery. Asian Spine J. 2016 Apr;10(2):366-9. doi: 10.4184/asj.2016.10.2.366. Epub 2016 Apr 15. — View Citation

Reeder B, David A. Health at hand: A systematic review of smart watch uses for health and wellness. J Biomed Inform. 2016 Oct;63:269-276. doi: 10.1016/j.jbi.2016.09.001. Epub 2016 Sep 6. — View Citation

Veerabhadrappa P, Moran MD, Renninger MD, Rhudy MB, Dreisbach SB, Gift KM. Tracking Steps on Apple Watch at Different Walking Speeds. J Gen Intern Med. 2018 Jun;33(6):795-796. doi: 10.1007/s11606-018-4332-y. — View Citation

Xie J, Wen D, Liang L, Jia Y, Gao L, Lei J. Evaluating the Validity of Current Mainstream Wearable Devices in Fitness Tracking Under Various Physical Activities: Comparative Study. JMIR Mhealth Uhealth. 2018 Apr 12;6(4):e94. doi: 10.2196/mhealth.9754. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Patient Compliance with Wearing Apple Watch		2-6 weeks pre-operatively
Primary	Patient Compliance with Wearing Apple Watch		4-6 weeks post-operatively
Primary	Patient Compliance with Wearing Apple Watch		3 months post-operatively
Primary	Patient Compliance with Wearing Apple Watch		6 months post-operatively
Primary	Patient Compliance with Wearing Apple Watch		12 months post-operatively
Primary	Patient Satisfaction with their Spine Care		4-6 weeks post-operatively
Primary	Patient Satisfaction with their Spine Care		3 months post-operatively
Primary	Patient Satisfaction with their Spine Care		6 months post-operatively
Primary	Patient Satisfaction with their Spine Care		12 months post-operatively

External Links

•   2017 Profile of Older Americans
•   Global Smartwatch Vendor Market Share