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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299556
• Other study ID #: 2017-0196
• Status: Completed
• Start date: October 5, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2019
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Purdue Pharma LP	Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Activity levels (WHT group only)	number of daily steps as measured by WHT application	12 months
Other	Sleep (WHT group only)	quantity (hours) and quality as measured by WHT application	12 months
Primary	Numerical Pain Score (NPS)	self reported 11-point pain scale	12 months
Primary	Patient Health Questionnaire (PHQ-9)	self reported measurement of depression	12 months
Primary	Mean daily morphine equivalents (MEQs)	calculated from health records, average amount of daily pain medication	12 months
Secondary	Oswestry Disability Index (ODI)	self reported measure of functionality, related to back and neck pain	12 months
Secondary	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
Secondary	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