NCT03299556

Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 420 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a proof of concept study to measure the effect of Wearable Health Technology (WHT), including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program (MPP). Primary and secondary outcomes include pain, physical function, depression, pain medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The WHT will collect self-reported data on pain, pain management therapies, and medication utilization, and passively collected data on subject activity levels and sleep. Additional data will be collected on device utilization by patients and health care professionals.

Detailed description

This is a prospective, non-randomized, non-blinded trial with historic and concurrent controls to assess the effect of the addition of WHT on patient and health system outcomes. WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed specifically for this study to be used with the watch and phone, and physician and patient dashboards also designed for this study to provide subjects and health care providers data displays of information captured by the WHT. The WHT will consist of: * AppleWatch and iPhone * Patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph) * Prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training Subjects will use the WHT 20 hours per day, every day for a period of 12 months. Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12. Outcome data for control groups will be collected retrospectively from the electronic health record (EHR). Assessments will have occurred as part of their standard of care.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
OTHER	WHT	Incorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training.

Timeline

• Start date: 2017-10-05
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2017-10-03
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States