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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Pain Other: WHT

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 Design

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
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.
Historic Control
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.
Concurrent Control
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


Outcome Measures

Primary Outcome Measures :
  1. Numerical Pain Score (NPS) [ Time Frame: 12 months ]
    self reported 11-point pain scale

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: 12 months ]
    self reported measurement of depression

  3. Mean daily morphine equivalents (MEQs) [ Time Frame: 12 months ]
    calculated from health records, average amount of daily pain medication


Secondary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 12 months ]
    self reported measure of functionality, related to back and neck pain

  2. 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

  3. 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


Other Outcome Measures:
  1. Activity levels (WHT group only) [ Time Frame: 12 months ]
    number of daily steps as measured by WHT application

  2. Sleep (WHT group only) [ Time Frame: 12 months ]
    quantity (hours) and quality as measured by WHT application


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Purdue Pharma LP
Geisinger Clinic
Investigators
Study Director: Thomas Alfieri, PhD Purdue Pharma LP
Principal Investigator: John J Han, MD Geisinger Clinic
More Information

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT03299556     History of Changes
Other Study ID Numbers: 2017-0196
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Purdue Pharma LP:
Wearable Health Technology
iPhone
Apple Watch
Pain Medication

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms