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

NCT03299556 | Completed Results DMC

• 1 other identifier: 2017-0196
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Wearable Health Technology; iPhone; Apple Watch; Pain Medication

Outcome Measures

Primary Outcomes (3)

• Numerical Pain Score (NPS)

  self reported 11-point pain scale. The numeric pain score (NPS) is self-reported by the patient on a scale of 0 to 10, with the following scale labels: no pain (0), mild pain (2), moderate pain (4), severe pain (6), very severe pain (8), and worst pain possible (10).

  Baseline, 12-month follow-up

• Patient Health Questionnaire (PHQ-9)

  self reported measurement of depression. The scale ranges from 0 to 27, indicating the following levels of depression severity: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).

  Baseline, 12-month follow-up

• Mean Daily Morphine Equivalents (MEQs)

  calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].

  Baseline, 12-month follow-up

Secondary Outcomes (1)

• Oswestry Disability Index (ODI)

  Baseline, 12-month follow-up

Other Outcomes (2)

• Activity Levels (WHT Group Only)

  12 months

• Sleep (WHT Group Only)

  12 months

Study Arms (3)

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

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

Interventions

WHT OTHER

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.

WHT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue Pharma LP: lead
• Geisinger Clinic: collaborator

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Links

• Long-term Use of Wearable Health Technology by Chronic Pain Patients

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Alfieri, PhD - Director, Medical Affairs Strategic Research
• Organization: Purdue Pharma L.P.

thomas.alfieri@pharma.com

(475) 299-6085

Study Officials

• Thomas Alfieri, PhD

  Purdue Pharma LP

  STUDY DIRECTOR

• John J Han, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: October 5, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)