Chronic Pain Clinical Trial
Official title:
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
NCT number | NCT03299556 |
Other study ID # | 2017-0196 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 5, 2017 |
Est. completion date | November 30, 2019 |
Verified date | December 2019 |
Source | Purdue Pharma LP |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Geisinger Health System | Danville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Purdue Pharma LP | Geisinger Clinic |
United States,
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 |
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