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

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

Sponsors

Lead Sponsor: Stanford University

Collaborator: Stryker Nordic

Source Stanford University
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.

Overall Status Not yet recruiting
Start Date June 1, 2020
Completion Date September 1, 2022
Primary Completion Date May 31, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure 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) 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) 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) 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) 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) 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
Enrollment 200
Condition
Intervention

Intervention Type: Device

Intervention Name: Apple Watch and App

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.

Arm Group Label: Apple Watch and App

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Corinna Zygourakis, MD Principal Investigator Department of Neurosurgery at Stanford University
Overall Contact

Last Name: Christopher Leung, BA

Phone: 2404996681

Email: [email protected]

Location
Facility: Contact: Stanford University Hospital Christopher Leung, BA 240-499-6681 [email protected]
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Stanford University

Investigator Full Name: Corinna Zygourakis

Investigator Title: Assistant Professor of Neurosurgery

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: No Intervention

Description: Participants will receive standard care.

Label: Apple Watch and App

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov