<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/NCT03308188</url>
  </required_header>
  <id_info>
    <org_study_id>2017-2301</org_study_id>
    <secondary_id>1R01DA044248-01</secondary_id>
    <nct_id>NCT03308188</nct_id>
  </id_info>
  <brief_title>EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications</brief_title>
  <official_title>EMPOWER: Evaluating the Ability to Reduce Morphine Equivalent Dose for Chronic Pain Patients Receiving Opioid-therapy Through a Web-based E-Health Self-management Program: a Randomized Multi-site Clinical Trial in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</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 10-month internet-based randomized controlled trial to evaluate whether an online&#xD;
      chronic pain management program (&quot;E-Health&quot;) can assist with reduced opioid reliance in&#xD;
      chronic pain patients. About half of the eligible participants will receive access to the&#xD;
      E-Health program in addition to their standard chronic pain treatment; the other half will&#xD;
      just continue receiving their standard chronic pain treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will determine whether an innovative, accessible E-health intervention can assist&#xD;
      with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of&#xD;
      unintended opioid overdose and death. Importantly, the study will contribute to a better&#xD;
      understanding of the mechanisms contributing to opioid use reduction while managing pain. The&#xD;
      findings may assist in developing treatment options for a population at risk for opioid&#xD;
      adverse effects.&#xD;
&#xD;
      Potential participants will be identified through electronic health record (EHR) queries at&#xD;
      participating sites. Participants will be assessed at baseline, at the end of the 4-month&#xD;
      treatment period, and at 6 months following end-of-treatment through an electronic data&#xD;
      capture system accessed by the participants. Other outcome data will be obtained from the&#xD;
      participant's EHR data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2018</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in Morphine Equivalent Dose (MED)</measure>
    <time_frame>Baseline and 10 months</time_frame>
    <description>Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>Baseline and 10 months</time_frame>
    <description>Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">402</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-Health+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>E-health program</intervention_name>
    <description>The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.</description>
    <arm_group_label>E-Health+</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 25-80 years of age&#xD;
&#xD;
          -  Be able to understand the study, and having understood, provide informed consent in&#xD;
             English&#xD;
&#xD;
          -  Have a daily average prescribed MED ≥ 20 mg over a recent three-month period&#xD;
&#xD;
          -  Have a chronic pain-related diagnosis&#xD;
&#xD;
          -  Self-report current use of opioid medication(s) to treat pain&#xD;
&#xD;
          -  Have a Brief Pain Inventory Pain Intensity score ≥3&#xD;
&#xD;
          -  Have internet access and a working email account&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Be anyone who, in the judgment of study staff, would be unlikely to complete the study&#xD;
             (e.g., planning to change to a different primary care clinic, have a terminal illness,&#xD;
             etc.)&#xD;
&#xD;
          -  Be unwilling/unable to complete the WebNeuro assessments&#xD;
&#xD;
          -  Be pregnant&#xD;
&#xD;
          -  Be a prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theresa Winhusen, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Health</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Health</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>T. John Winhusen, PhD</investigator_full_name>
    <investigator_title>Professor; Vice Chair and Division Director of Addiction Sciences</investigator_title>
  </responsible_party>
  <keyword>Opioid therapy</keyword>
  <keyword>web-based intervention</keyword>
  <keyword>self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 9, 2023</submitted>
    <returned>August 29, 2023</returned>
    <submitted>September 1, 2023</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/NCT03308188
org study id: 2017-2301
secondary id: 1R01DA044248-01
nct id: NCT03308188
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a 10-month internet-based randomized controlled trial to evaluate whether an online
      chronic pain management program ("E-Health") can assist with reduced opioid reliance in
      chronic pain patients. About half of the eligible participants will receive access to the
      E-Health program in addition to their standard chronic pain treatment; the other half will
      just continue receiving their standard chronic pain treatment.
This study will determine whether an innovative, accessible E-health intervention can assist
      with reduced opioid reliance in chronic pain patients, which can, ultimately, reduce risks of
      unintended opioid overdose and death. Importantly, the study will contribute to a better
      understanding of the mechanisms contributing to opioid use reduction while managing pain. The
      findings may assist in developing treatment options for a population at risk for opioid
      adverse effects.

      Potential participants will be identified through electronic health record (EHR) queries at
      participating sites. Participants will be assessed at baseline, at the end of the 4-month
      treatment period, and at 6 months following end-of-treatment through an electronic data
      capture system accessed by the participants. Other outcome data will be obtained from the
      participant's EHR data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decrease in Morphine Equivalent Dose (MED)
time frame: Baseline and 10 months
description: Whether (yes/no) there was a ≥15% decrease in MED, between baseline and 10-month post-randomization follow-up.
measure: Pain Intensity
time frame: Baseline and 10 months
description: Whether (yes/no) there is a clinically meaningful decrease in pain intensity (at least 2 points) as measured by the Brief Pain Inventory (BPI), between baseline and 10-month post-randomization follow-up.
arm group label: Treatment As Usual
arm group type: No Intervention
description: Participants randomized to Treatment As Usual will receive treatment for chronic pain as typically provided by their clinician -- they will receive no extra treatment from the study.
arm group label: E-Health+
arm group type: Experimental
description: Participants randomized to the E-health+ arm will receive treatment as typically provided by their clinician plus a 4-month subscription to the E-health program, which is an internet based chronic pain program.
intervention type: Behavioral
intervention name: E-health program
description: The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
arm group label: E-Health+
criteria: 
gender: All
minimum age: 25 Years
maximum age: 80 Years
healthy volunteers: No
last name: Theresa Winhusen, Ph.D.
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: T. John Winhusen, PhD
investigator title: Professor; Vice Chair and Division Director of Addiction Sciences
mesh term: Chronic Pain
submitted: August 9, 2023
returned: August 29, 2023
submitted: September 1, 2023