N/A
Completed N=420
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
Source: ClinicalTrials.gov NCT03299556 ↗Enrolled (actual)
420
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Numerical Pain Score (NPS) — 5.48; 6.50; 6.48; 5.22 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Pain Score (NPS) |
5.48; 6.50; 6.48; 5.22; 6.10; 6.15 | — |
| PRIMARY Patient Health Questionnaire (PHQ-9) |
14.07; 15.19; 14.63; 11.78; 12.89; 11.31 | — |
| PRIMARY Mean Daily Morphine Equivalents (MEQs) |
51.38; 56.83; 43.42; 38.36; 54.46; 43.69 | — |
| SECONDARY Oswestry Disability Index (ODI) |
47.67; 55.05; 51.20; 45.46; 53.99; 46.28 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03299556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.