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

Not Applicable

Active, not recruiting

• Conditions: Spinal Stenosis; Surgery; Spine Disease; Spine Fusion; Spine Degeneration
• Interventions: Device: Apple Watch and App

• Registration Number: NCT04379921
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-30
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-08
• Study Start: 2020-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2024-11-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• English-speaking.
• Undergoing elective spine surgery by attending physicians at Stanford University.
• Own iPhone

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Exclusion Criteria

• Patients with spine trauma, tumors, or infection.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	12 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	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.
Patient Satisfaction with their Spine Care	12 months post-operatively

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Palo Alto, California, United States