Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
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|ClinicalTrials.gov Identifier: NCT03299556|
Recruitment Status : Enrolling by invitation
First Posted : October 3, 2017
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment|
|Chronic Pain||Other: WHT|
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|
|Estimated Enrollment :||240 participants|
|Official Title:||Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System|
|Actual Study Start Date :||October 5, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
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.
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.
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.
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
- Numerical Pain Score (NPS) [ Time Frame: 12 months ]self reported 11-point pain scale
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 months ]self reported measurement of depression
- Mean daily morphine equivalents (MEQs) [ Time Frame: 12 months ]calculated from health records, average amount of daily pain medication
- Oswestry Disability Index (ODI) [ Time Frame: 12 months ]self reported measure of functionality, related to back and neck pain
- Healthcare resource utilization [ Time Frame: 6 months before WHT-use compared to months 7-12 post WHT-use ]number of hospitalizations, emergency department visits, outpatient visits, rehabilitation visits, and pharmacy/medication orders
- Direct medical costs [ Time Frame: 6 months before WHT-use compared to months 7-12 post WHT-use ]total costs, and costs related to inpatient, outpatient, rehabilitation, and pharmacy
- Activity levels (WHT group only) [ Time Frame: 12 months ]number of daily steps as measured by WHT application
- Sleep (WHT group only) [ Time Frame: 12 months ]quantity (hours) and quality as measured by WHT application
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299556
|United States, Pennsylvania|
|Geisinger Health System|
|Danville, Pennsylvania, United States, 17822|
|Study Director:||Thomas Alfieri, PhD||Purdue Pharma LP|
|Principal Investigator:||John J Han, MD||Geisinger Clinic|