<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299556</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0196</org_study_id>
    <nct_id>NCT03299556</nct_id>
  </id_info>
  <brief_title>Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System</brief_title>
  <official_title>Effect of Wearable Health Technology on Patients Treated for Chronic Pain at Geisinger Health System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue Pharma LP</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Purdue Pharma LP</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a proof of concept study to measure the effect of Wearable Health Technology (WHT),&#xD;
      including the Apple Watch, iPhone, Pain App and Provider Dashboards on important clinical&#xD;
      outcomes in patients treated for chronic pain. WHT will be tested in a group of chronic pain&#xD;
      patients treated at a specialty pain clinic, the Geisinger Multidisciplinary Pain Program&#xD;
      (MPP). Primary and secondary outcomes include pain, physical function, depression, pain&#xD;
      medicine use, amount of sleep, activity levels, healthcare resource utilization and cost. The&#xD;
      WHT will collect self-reported data on pain, pain management therapies, and medication&#xD;
      utilization, and passively collected data on subject activity levels and sleep. Additional&#xD;
      data will be collected on device utilization by patients and health care professionals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, non-blinded trial with historic and concurrent&#xD;
      controls to assess the effect of the addition of WHT on patient and health system outcomes.&#xD;
      WHT used in this study are the Apple Watch and iPhone, a pain application (Pain App) designed&#xD;
      specifically for this study to be used with the watch and phone, and physician and patient&#xD;
      dashboards also designed for this study to provide subjects and health care providers data&#xD;
      displays of information captured by the WHT.&#xD;
&#xD;
      The WHT will consist of:&#xD;
&#xD;
        -  AppleWatch and iPhone&#xD;
&#xD;
        -  Patient and provider tracking of patient-reported pain, pain management, medication&#xD;
           usage, functionality, depression, activity and sleep (measured by 3 axis actigraph)&#xD;
&#xD;
        -  Prompts to subjects to engage in self-care, including non-pharmaceutical pain management&#xD;
           therapies consistent with MPP training&#xD;
&#xD;
      Subjects will use the WHT 20 hours per day, every day for a period of 12 months.&#xD;
&#xD;
      Subjects will attend study visits at baseline and months 2, 4, 6, 8, 10 and 12.&#xD;
&#xD;
      Outcome data for control groups will be collected retrospectively from the electronic health&#xD;
      record (EHR). Assessments will have occurred as part of their standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Pain Score (NPS)</measure>
    <time_frame>12 months</time_frame>
    <description>self reported 11-point pain scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>12 months</time_frame>
    <description>self reported measurement of depression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean daily morphine equivalents (MEQs)</measure>
    <time_frame>12 months</time_frame>
    <description>calculated from health records, average amount of daily pain medication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>12 months</time_frame>
    <description>self reported measure of functionality, related to back and neck pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource utilization</measure>
    <time_frame>6 months before WHT-use compared to months 7-12 post WHT-use</time_frame>
    <description>number of hospitalizations, emergency department visits, outpatient visits, rehabilitation visits, and pharmacy/medication orders</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct medical costs</measure>
    <time_frame>6 months before WHT-use compared to months 7-12 post WHT-use</time_frame>
    <description>total costs, and costs related to inpatient, outpatient, rehabilitation, and pharmacy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Activity levels (WHT group only)</measure>
    <time_frame>12 months</time_frame>
    <description>number of daily steps as measured by WHT application</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep (WHT group only)</measure>
    <time_frame>12 months</time_frame>
    <description>quantity (hours) and quality as measured by WHT application</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">135</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>WHT</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historic Control</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concurrent Control</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>WHT</intervention_name>
    <description>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.</description>
    <arm_group_label>WHT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Geisinger chronic pain patients, currently or previously enrolled in the MPP or currently&#xD;
        receiving treatment in the MPM program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to the MPP&#xD;
&#xD;
          -  Completion of the 3-day MPP training&#xD;
&#xD;
          -  Ability to understand and complete the informed consent form prior to the initiation&#xD;
             of any study procedures&#xD;
&#xD;
          -  Adequate motor skills needed to utilize WHT&#xD;
&#xD;
          -  Willingness to utilize personal electronic devices and WHT, as expressed and&#xD;
             documented during the informed consenting process&#xD;
&#xD;
          -  Ability to understand spoken and written English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer diagnosis, AIDS, end-stage liver disease or end-stage renal disease&#xD;
&#xD;
          -  Hospitalization &gt;30 days during the 12 months prior to Index Date&#xD;
&#xD;
          -  Nursing home or hospice care during the 12 months prior to Index Date&#xD;
&#xD;
          -  Presence of an EHR Diagnosis description &quot;OPT-OUT CENTER RESEARCH&quot; which indicates the&#xD;
             subject has opted out of (i.e., does not wish to be included in) any Geisinger&#xD;
             retrospective research&#xD;
&#xD;
          -  Has a terminated Medicine Use Agreement on their Problem List, indicator for substance&#xD;
             abuse/dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Alfieri, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Purdue Pharma LP</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John J Han, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Health System</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 12, 2019</last_update_submitted>
  <last_update_submitted_qc>December 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wearable Health Technology</keyword>
  <keyword>iPhone</keyword>
  <keyword>Apple Watch</keyword>
  <keyword>Pain Medication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 21, 2022</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299556
org study id: 2017-0196
nct id: NCT03299556
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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:

        -  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.
observational model: Cohort
time perspective: Prospective
measure: Numerical Pain Score (NPS)
time frame: 12 months
description: self reported 11-point pain scale
measure: Patient Health Questionnaire (PHQ-9)
time frame: 12 months
description: self reported measurement of depression
measure: Mean daily morphine equivalents (MEQs)
time frame: 12 months
description: calculated from health records, average amount of daily pain medication
measure: Oswestry Disability Index (ODI)
time frame: 12 months
description: self reported measure of functionality, related to back and neck pain
measure: Healthcare resource utilization
time frame: 6 months before WHT-use compared to months 7-12 post WHT-use
description: number of hospitalizations, emergency department visits, outpatient visits, rehabilitation visits, and pharmacy/medication orders
measure: Direct medical costs
time frame: 6 months before WHT-use compared to months 7-12 post WHT-use
description: total costs, and costs related to inpatient, outpatient, rehabilitation, and pharmacy
measure: Activity levels (WHT group only)
time frame: 12 months
description: number of daily steps as measured by WHT application
measure: Sleep (WHT group only)
time frame: 12 months
description: quantity (hours) and quality as measured by WHT application
arm group label: WHT
description: 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.
arm group label: Historic Control
description: 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.
arm group label: Concurrent Control
description: 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
intervention type: Other
intervention name: WHT
description: 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.
arm group label: WHT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Alfieri, PhD
role: Study Director
affiliation: Purdue Pharma LP
last name: John J Han, MD
role: Principal Investigator
affiliation: Geisinger Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: No
submitted: November 21, 2022