Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | October 5, 2017 |
| End Date: | October 2019 |
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.
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.
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.
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.
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
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