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

NCT ID: NCT03299556

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-05
• Study Completion Date: 2019-11-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

WHT

The WHT group includes only patients newly enrolled in the Geisinger MPP program who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up.

WHT

Intervention Type: OTHER

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.

Historic Control

Patients who were enrolled in the MPP in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment.

No interventions assigned to this group

Concurrent Control

Patients being treated for chronic pain in the Geisinger Medical Pain Management (MPM) program over the same time period as the WHT group. These subjects do not receive the MPP educational program nor use WHT as part of their treatment

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admission to the MPP
• Completion of the 3-day MPP training
• Ability to understand and complete the informed consent form prior to the initiation of any study procedures
• Adequate motor skills needed to utilize WHT
• Willingness to utilize personal electronic devices and WHT, as expressed and documented during the informed consenting process
• Ability to understand spoken and written English

Exclusion Criteria

• Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease
• Hospitalization >30 days during the 12 months prior to Index Date
• Nursing home or hospice care during the 12 months prior to Index Date
• Presence of an EHR Diagnosis description "OPT-OUT CENTER RESEARCH" which indicates the subject has opted out of (i.e., does not wish to be included in) any Geisinger retrospective research
• Has a terminated Medicine Use Agreement on their Problem List, indicator for substance abuse/dependence

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: collaborator

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Alfieri, PhD

Role: STUDY_DIRECTOR

Purdue Pharma LP

John J Han, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Health System

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://journals.lww.com/clinicalpain/Fulltext/2022/12000/Long_term_Use_of_Wearable_Health_Technology_by.1.aspx

Long-term Use of Wearable Health Technology by Chronic Pain Patients

Other Identifiers

2017-0196

Identifier Type: -

Identifier Source: org_study_id