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| Name | Class |
|---|---|
| Geisinger Clinic | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Levels (WHT Group Only) | number of daily steps as measured by WHT application. Insufficient data collected for analysis of this outcome measure. | 12 months |
| Sleep (WHT Group Only) | quantity (hours) and quality as measured by WHT application. Insufficient data collected for analysis of this outcome measure. |
Inclusion Criteria:
Exclusion Criteria:
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Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently receiving treatment in the MPM program.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Alfieri, PhD | Purdue Pharma LP | Study Director |
| John J Han, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Health System | Danville | Pennsylvania | 17822 | United States |
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| Label | URL |
|---|---|
| Long-term Use of Wearable Health Technology by Chronic Pain Patients | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Historic Control (MPP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12-month follow-up |
|
Adverse events were collected up to 12 months for participants in the WHT group. Up to a 12-month retrospective review of AE data was performed for the patients in the MPP and MPM control groups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Alfieri, PhD - Director, Medical Affairs Strategic Research | Purdue Pharma L.P. | (475) 299-6085 | thomas.alfieri@pharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2017 | Oct 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Baseline, 12-month follow-up |
| 12 months |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12-month follow-up |
|
|
|
| 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)]. | Posted | Mean | Standard Deviation | MME | Baseline, 12-month follow-up |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Deviation | score on a scale | Baseline, 12-month follow-up |
|
|
|
| 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. | Not Posted | 12 months | Participants |
| 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. | Not Posted | 12 months | Participants |
| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | 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. | 0 | 146 | 0 | 146 | 0 | 146 |
| EG002 | 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. | 0 | 161 | 0 | 161 | 0 | 161 |
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| ODI (Back) 12-month follow-up |
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| ODI (Neck) Baseline |
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| ODI (Neck) 12-month follow-up |
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