Clinical trial NCT03299556: Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
Official title: Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Wearable Health Technology
iPhone
Apple Watch
Pain Medication
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
Collaborators: name: Geisinger Clinic
First posted: 2017-10-03
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Numerical Pain Score (NPS)
timeFrame: Baseline, 12-month follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 12-month follow-up
measure: Mean Daily Morphine Equivalents (MEQs)
timeFrame: Baseline, 12-month follow-up
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, 12-month follow-up
Other outcomes:
measure: Activity Levels (WHT Group Only)
timeFrame: 12 months
measure: Sleep (WHT Group Only)
timeFrame: 12 months
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Purdue Pharma LP
name: Thomas Alfieri, PhD
role: STUDY_DIRECTOR
affiliation: Geisinger Clinic
name: John J Han, MD
role: PRINCIPAL_INVESTIGATOR
References: