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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: WHT

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.

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Pain Score (NPS)	self reported 11-point pain scale	12 months
Patient Health Questionnaire (PHQ-9)	self reported measurement of depression	12 months
Mean daily morphine equivalents (MEQs)	calculated from health records, average amount of daily pain medication	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index (ODI)	self reported measure of functionality, related to back and neck pain	12 months
Healthcare resource utilization	number of hospitalizations, emergency department visits, outpatient visits, rehabilitation visits, and pharmacy/medication orders	6 months before WHT-use compared to months 7-12 post WHT-use
Direct medical costs	total costs, and costs related to inpatient, outpatient, rehabilitation, and pharmacy	6 months before WHT-use compared to months 7-12 post WHT-use

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity levels (WHT group only)	number of daily steps as measured by WHT application	12 months
Sleep (WHT group only)	quantity (hours) and quality as measured by WHT application	12 months

Collaborators and Investigators

• Sponsor: Purdue Pharma LP
• Collaborators: Geisinger Clinic
• Investigators: Study Director: Thomas Alfieri, PhD, Purdue Pharma LP; Principal Investigator: John J Han, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2017
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (ACTUAL): October 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: iPhone; Apple Watch; Wearable Health Technology; Pain Medication
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2017-0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No