Chronic Pain
Conditions
Keywords
Wearable Health Technology, iPhone, Apple Watch, Pain Medication
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.
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.
Interventions
OTHERWHT
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.
Sponsors
Geisinger Clinic
Purdue Pharma LP
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Score (NPS) | 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). |
| Patient Health Questionnaire (PHQ-9) | 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). |
| Mean Daily Morphine Equivalents (MEQs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Activity Levels (WHT Group Only) | 12 months | number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure. |
| Sleep (WHT Group Only) | 12 months | quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wearable Health Tracker (WHT) The WHT group includes only patients newly enrolled in the Geisinger Multidisciplinary Pain Program (MPP) who consent to participate in the study. WHT subjects will be recruited over 1 year, with 1 year of follow-up. | 105 |
| Historic Control (MPP) Patients who were enrolled in the Multidisciplinary Pain Program (MPP) in the preceding year. These patients received the MPP educational program but received no WHT as part of their treatment. | 146 |
| Concurrent Control (MPM) 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. | 161 |
| Total | 412 |
Baseline characteristics
| Characteristic | Wearable Health Tracker (WHT) | Historic Control (MPP) | Concurrent Control (MPM) | Total |
|---|---|---|---|---|
| Age, Continuous | 50.1 years STANDARD_DEVIATION 12.8 | 50.4 years STANDARD_DEVIATION 11.8 | 47.1 years STANDARD_DEVIATION 12.5 | 49.0 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 8 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 142 Participants | 153 Participants | 397 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 102 Participants | 139 Participants | 151 Participants | 392 Participants |
| Sex: Female, Male Female | 81 Participants | 93 Participants | 110 Participants | 284 Participants |
| Sex: Female, Male Male | 24 Participants | 53 Participants | 51 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 146 | 0 / 161 |
| other Total, other adverse events | 0 / 113 | 0 / 146 | 0 / 161 |
| serious Total, serious adverse events | 0 / 113 | 0 / 146 | 0 / 161 |
Outcome results
Primary
Mean Daily Morphine Equivalents (MEQs)
calculated from health records, average amount of daily pain medication \[as measured by the daily milligrams of morphine equivalents (MME)\].
Time frame: Baseline, 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wearable Health Tracker (WHT) | Mean Daily Morphine Equivalents (MEQs) | Baseline | 51.38 MME | Standard Deviation 44.84 |
| Wearable Health Tracker (WHT) | Mean Daily Morphine Equivalents (MEQs) | 12-month follow-up | 38.36 MME | Standard Deviation 34.88 |
| Historic Control (MPP) | Mean Daily Morphine Equivalents (MEQs) | Baseline | 56.83 MME | Standard Deviation 76.3 |
| Historic Control (MPP) | Mean Daily Morphine Equivalents (MEQs) | 12-month follow-up | 54.46 MME | Standard Deviation 66.51 |
| Concurrent Control (MPM) | Mean Daily Morphine Equivalents (MEQs) | Baseline | 43.42 MME | Standard Deviation 68.62 |
| Concurrent Control (MPM) | Mean Daily Morphine Equivalents (MEQs) | 12-month follow-up | 43.69 MME | Standard Deviation 51.39 |
Primary
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).
Time frame: Baseline, 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wearable Health Tracker (WHT) | Numerical Pain Score (NPS) | Baseline | 5.48 score on a scale | Standard Deviation 1.5 |
| Wearable Health Tracker (WHT) | Numerical Pain Score (NPS) | 12-month follow-up | 5.22 score on a scale | Standard Deviation 1.53 |
| Historic Control (MPP) | Numerical Pain Score (NPS) | Baseline | 6.50 score on a scale | Standard Deviation 1.57 |
| Historic Control (MPP) | Numerical Pain Score (NPS) | 12-month follow-up | 6.10 score on a scale | Standard Deviation 1.36 |
| Concurrent Control (MPM) | Numerical Pain Score (NPS) | Baseline | 6.48 score on a scale | Standard Deviation 1.7 |
| Concurrent Control (MPM) | Numerical Pain Score (NPS) | 12-month follow-up | 6.15 score on a scale | Standard Deviation 1.54 |
Primary
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).
Time frame: Baseline, 12-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wearable Health Tracker (WHT) | Patient Health Questionnaire (PHQ-9) | Baseline | 14.07 score on a scale | Standard Deviation 5.65 |
| Wearable Health Tracker (WHT) | Patient Health Questionnaire (PHQ-9) | 12-month follow-up | 11.78 score on a scale | Standard Deviation 6.18 |
| Historic Control (MPP) | Patient Health Questionnaire (PHQ-9) | Baseline | 15.19 score on a scale | Standard Deviation 6.34 |
| Historic Control (MPP) | Patient Health Questionnaire (PHQ-9) | 12-month follow-up | 12.89 score on a scale | Standard Deviation 6.25 |
| Concurrent Control (MPM) | Patient Health Questionnaire (PHQ-9) | Baseline | 14.63 score on a scale | Standard Deviation 4.9 |
| Concurrent Control (MPM) | Patient Health Questionnaire (PHQ-9) | 12-month follow-up | 11.31 score on a scale | Standard Deviation 5.73 |
Secondary
Oswestry Disability Index (ODI)
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.
Time frame: Baseline, 12-month follow-up
Population: The numbers analyzed differ because two different measures were used - the ODI Back was administered only to patients with back pain, the ODI Neck was administered only to patients with neck pain.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Wearable Health Tracker (WHT) | Oswestry Disability Index (ODI) | ODI (Back) Baseline | 47.67 score on a scale | Standard Deviation 13.54 |
| Wearable Health Tracker (WHT) | Oswestry Disability Index (ODI) | ODI (Back) 12-month follow-up | 45.46 score on a scale | Standard Deviation 14.38 |
| Wearable Health Tracker (WHT) | Oswestry Disability Index (ODI) | ODI (Neck) Baseline | 50.07 score on a scale | Standard Deviation 14.51 |
| Wearable Health Tracker (WHT) | Oswestry Disability Index (ODI) | ODI (Neck) 12-month follow-up | 51.03 score on a scale | Standard Deviation 14.5 |
| Historic Control (MPP) | Oswestry Disability Index (ODI) | ODI (Neck) 12-month follow-up | 59.59 score on a scale | Standard Deviation 13.79 |
| Historic Control (MPP) | Oswestry Disability Index (ODI) | ODI (Back) Baseline | 55.05 score on a scale | Standard Deviation 12.43 |
| Historic Control (MPP) | Oswestry Disability Index (ODI) | ODI (Neck) Baseline | 59.23 score on a scale | Standard Deviation 13.96 |
| Historic Control (MPP) | Oswestry Disability Index (ODI) | ODI (Back) 12-month follow-up | 53.99 score on a scale | Standard Deviation 12.99 |
| Concurrent Control (MPM) | Oswestry Disability Index (ODI) | ODI (Neck) 12-month follow-up | 51.40 score on a scale | Standard Deviation 17.27 |
| Concurrent Control (MPM) | Oswestry Disability Index (ODI) | ODI (Back) 12-month follow-up | 46.28 score on a scale | Standard Deviation 16.74 |
| Concurrent Control (MPM) | Oswestry Disability Index (ODI) | ODI (Neck) Baseline | 53.10 score on a scale | Standard Deviation 13.7 |
| Concurrent Control (MPM) | Oswestry Disability Index (ODI) | ODI (Back) Baseline | 51.20 score on a scale | Standard Deviation 11.78 |
Other Pre-specified
Activity Levels (WHT Group Only)
number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Time frame: 12 months
Other Pre-specified
Sleep (WHT Group Only)
quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure.
Time frame: 12 months