Skip to main content
OpenTrials
Completed

NCT Number: NCT03299556

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Numerical Pain Score (NPS)

    Time frame: Baseline, 12-month follow-up

    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).

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline, 12-month follow-up

    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).

  3. Mean Daily Morphine Equivalents (MEQs)

    Time frame: Baseline, 12-month follow-up

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

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Baseline, 12-month follow-up

    self reported measure of functionality, related to back and neck pain. The ODI is a self-administered questionnaire assessing symptoms and severity of back or neck pain on a scale from 0 to 100. This measurement evaluates the loss of function in activities of daily living. Two ODI questionnaires were used in this study, one for neck pain and one for back pain. Interpretation of ODI scoring is as follows: minimal disability (0-20), moderate disability (21-40), severe disability (41-60), and crippled (61-80). Scores over 80 suggest the patient may be bedbound or exaggerating their symptoms and careful evaluation is recommended.

Other outcomes

  1. Activity Levels (WHT Group Only)

    Time frame: 12 months

    number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.

  2. Sleep (WHT Group Only)

    Time frame: 12 months

    quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.

Sponsors and collaborators

Lead sponsor

Purdue Pharma LP

Industry

Collaborators

  • Geisinger Clinic

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.