Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System
Conditions: Chronic Pain
Sponsor: Purdue Pharma LP

Official Title: Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger 
Health System 
NCT#: NCT03299556 
Date of Document: September 12, 2017 

Protocol Synopsis 
Protocol 
Number: 
2017-0196 
Title: 
Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger 
Health System 
Sponsor: 
Purdue Pharma L.P. 
One Stamford Forum 
201 Tresser Boulevard 
Stamford, CT 06901-3431 
Study Phase: Phase 4 
Study Sites: 
The study will be conducted in the United States at 1 site, the Multidisciplinary Pain
Program at Geisinger Health System 
Indication: 
Chronic Pain 
Background: Care for the chronic pain patients can be challenging. Providers are dependent on patients’ 
recall of their symptoms between visits to gauge disease severity and treatment progress.
Providers often lack timely access to patients’ data on symptom severity, thereby limiting
the providers’ ability to effectively manage and optimize long-term treatment regimens for
their patients. 
Recent use of wearable health technology (WHT) has been effective in improving patient
outcomes. Many wearable biosensors and their applications have been introduced in 
different stand-alone or interactive formats. WHT apps may have interactive capabilities
involving active health or behavior change information that collects data from the user.
WHT can detect abnormal and unforeseen situations and monitor physiological parameters 
and symptoms through these trackers. This technology has transformed healthcare by
allowing continuous monitoring of patients without hospitalization. Medical monitoring of 
patients’ body temperature, heart rate, brain activity, muscle motion and other critical data
can be delivered through these trackers. When integrated with an expert-directed chronic
pain intervention program like Geisinger’s Multidisciplinary Pain Program (MPP), WHT
(eg iPhone, Apple Watch) may improve comprehensive patient management and outcomes
for patients living with chronic disease. WHT can also provide real-time data, allowing a
healthcare provider to engage in more proactive patient care. 
Objectives 
To assess whether the addition of WHT to the Geisinger MPP leads to improvements in 
clinically meaningful patient outcomes, reductions in healthcare utilization and costs.  
 

Patient 
Population: 
The study population will be adult (≥18 to <76 years) chronic pain patients being treated 
at pain clinics in the Geisinger healthcare system.  
There will 3 study groups, a WHT treatment group, a concurrent Medical Pain 
Management (MPM) control, and an historic MPP control: 
1. WHT treatment group: patients admitted to the MPP during a predefined 12-
month period who consented to participate in the study. 
2. MPM control group: patients from MPM clinics within Geisinger during the same 
12-month period. 
3. Historic MPP control group: patients who completed the MPP 12 months before 
the start of this study (ie, before WHT was introduced to the MPP in August 
2017). 
Study Design: This is a prospective, non-randomized, non-blinded trial with historic and concurrent 
controls to assess the effect of the addition of WHT (Apple Watch, iPhone, Pain App, and
physician and patient dashboards) on patient and health system outcomes. The WHT 
intervention group will include patients enrolled in the Geisinger’s MPP Program over 1 
year, with 1 year of follow up. Patients in the WHT group will be compared to patients in 
2 control groups: patients enrolled in the MPP in the preceding year (historic control 
group), and patients enrolled on the MPM over the same period (concurrent control 
group). 
The WHT intervention will consist of the following: 
• 
Patient and HCP tracking of patient-reported pain, pain management, disability, 
depression and medication usage over time 
• 
Patient and HCP tracking of quality of sleep and activity over time 
• 
Prompts to patients to engage in self-care, including non-pharmaceutical pain 
management therapies consistent with their MPP training 
• 
HCP alerts if patients exceed pre-specified thresholds in pain or functioning 
Patients will use the WHT 20 hours per day, every day for a period of 12 months. 
Patients will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12. Patients 
consented into the WHT group will participate in the study for 12 months from the day of 
enrollment. 
Outcome data for control patients will be collected retrospectively from the electronic 
health record (EHR).  Assessments will have occurred as part of their standard of care. 
Estimated 
Study 
Duration: 
Twelve months of enrollment, with 12 months of follow-up, for a total of 24 months.   

Outcome 
Measures: 
Study Aim 1 (Between- Group Differences) 
• 
Primary Clinical Endpoints 
o A difference in the change in pain scores over time from baseline to 
month 12 (M12) as measured by the Numerical Pain Score (NPS) 
o A difference in the change in depression scores over time from baseline 
to M12 as measured by the Patient Health Questionnaire (PHQ-9) 
o A difference in the change in pain medication use over time from 
baseline to M12, calculated as mean daily morphine equivalents (MEQs)  
• 
Secondary Clinical Endpoints 
o A difference in the change in physical function/disability over time from 
baseline to M12 as measured by the Oswestry Disability Index (ODI) 
• 
Endpoints Related to Resource Utilization 
o A difference in the change in healthcare resource utilization over time 
(quarterly) from baseline to M12: number of hospitalizations, emergency 
department (ED) visits, inpatient, outpatient visits, rehabilitation visits, 
and pharmacy/medication orders 
o A difference in the change in healthcare costs over time (quarterly) from 
baseline to M12: total, inpatient, outpatient, rehabilitation, and pharmacy 
Study Aim 2 Comparisons within WHT Group 
• 
Sleep: change in number of hours and number of restful hours per night over time
from month 1 (M1) to M12 
• 
Activity level: change in number of steps and minutes of exercise per day over 
time from M1 to M12  
• 
Daily pain scores: change in worst pain of the day (mean value for the month), 
number of episodes of breakthrough pain (episodes per 7 days), and mean level 
of breakthrough pain (mean value for month) over time from M1 to M12 
Sample  
Size: 
Sample size estimated to be at least 240 WHT patients, 1000 MPM patients, and 
150 historic MPP patients. Based on these sample sizes, and assuming a 10% drop-out 
rate, detectable effect sizes at 80% power for the primary clinical outcomes as analyzed 
by repeated measures analysis of variance (ANOVA) model and using an omnibus F test 
(difference in changes between the groups at any time) are: 
• 
NPS: 0.35 versus MPM; 0.42 versus historic MPP 
• 
PHQ-8: 1.40 versus MPM; 1.81 versus historic MPP 
• 
MEQs: 11.51 versus MPM; 17.58 versus historic MPP 

Statistical 
Methods: 
For clinical outcomes (primary, secondary, and exploratory), the effects of WHT will be 
quantified by calculating the change from baseline in clinical outcome variables in the 
WHT group over 12 months.  For primary and secondary outcomes that are measured in 
the WHT group plus at least 1 control group, generalized linear modeling or 
nonparametric methods (depending on the score distributions) will be used to compare 
outcomes across the cohorts. Patient demographic and clinical characteristics that differ 
between groups at baseline will be included in multivariate adjusted models. 
Repeated measures models will be used to generate point estimates and 95% confidence 
intervals (CIs) for least square mean (LSM) differences, odds ratios (ORs), or risk ratios 
(RRs). Where appropriate an overall F statistic will be generated to compare the change 
in groups across the study period (interaction of group*time). 
For the analysis of healthcare utilization, a log-link function with a Poisson or negative 
binomial distribution will be used. For cost outcomes, a log-link function with a gamma 
distribution will be used. Otherwise, the same techniques described above (eg, GLM 
methods to account for matched groups, estimates, and CIs) will be used. 
For analysis related to clinical outcomes collected only in the WHT group, the effects of 
WHT will be quantified by calculating the change from baseline over 12 months and 
using repeated measures ANCOVA models to compare to the null hypothesis (0 change). 
Date of 
Protocol: 
12 September 2017