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

Completed

• Conditions: Chronic Pain
• Interventions: Other: WHT

• Registration Number: NCT03299556
• Lead Sponsor: Purdue Pharma LP

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.

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2017-10-05
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WHT	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.

Primary Outcome Measures

Name	Time	Method
Numerical Pain Score (NPS)	Baseline, 12-month follow-up	self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).
Patient Health Questionnaire (PHQ-9)	Baseline, 12-month follow-up	self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Mean Daily Morphine Equivalents (MEQs)	Baseline, 12-month follow-up	calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Baseline, 12-month follow-up	self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.

Trial Locations

Locations (1)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States