<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/NCT04462250</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2020001699</org_study_id>
    <nct_id>NCT04462250</nct_id>
  </id_info>
  <brief_title>Mobile Health (mHealth) App for Safe Opioid Use</brief_title>
  <official_title>Development of a Mobile Health App to Improve the Safe Use, Storage, and Disposal of Opioid Medications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A key driver of the current opioid overdose epidemic is the misuse of legitimately prescribed&#xD;
      opioid medications. Patient education through use of mobile technology may help to increase&#xD;
      knowledge of appropriate use of opioid medications; however, knowledge does not always&#xD;
      translate into behavior modification. Therefore, there is a need for more research into&#xD;
      patient-facing technology that can increase both knowledge and behaviors consistent with&#xD;
      appropriate opioid use. These needs have been amplified by the severe acute respiratory&#xD;
      syndrome coronavirus-2 (COVID-19) pandemic, which has exposed healthcare disparities,&#xD;
      heightened the risk for mental and behavioral health disorders, and dramatically increased&#xD;
      reliance on telehealth technologies. It is critically important that telehealth solutions be&#xD;
      accessible and user-friendly for all consumers, particularly members of underserved&#xD;
      communities with limited digital health literacy. This feasibility study will develop a&#xD;
      mobile health app to improve appropriate use of opioid medications among patients with a&#xD;
      prescription to treat non-cancer pain. The study will use focus groups with consumers and&#xD;
      providers to determine the content and features to be included in the app and will test the&#xD;
      feasibility of implementing a contingency management approach (i.e., rewards system) with the&#xD;
      app using a randomized control trial. The key outcome of interest is confirmation of the&#xD;
      design and operating specifications of the app, including the use of contingency management.&#xD;
      Secondary outcomes of interest are the overall rating of the app and an increase in knowledge&#xD;
      among users regarding the safe use, storage, and disposal of opioid medications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2022</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>Device Feasibility</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants will enter all data using a numeric identifier assigned by a third-party recruiter</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Device functionality</measure>
    <time_frame>Assessed at the end of the one-week trial</time_frame>
    <description>Confirmation that the app features work as intended based on user input</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mobile App Rating Scale (MARS)</measure>
    <time_frame>Data collected through app and telephone interviews at the end of the one-week trial</time_frame>
    <description>Participants' assessment of functionality and utility of app with 19 items scored from 1 to 5 (overall score range 19 to 95) where higher scores indicate better app rating</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge quiz score</measure>
    <time_frame>Change in score as assessed at the end of the one-week trial</time_frame>
    <description>Participants will show an increase in knowledge related to the safe used, storage, and disposal of opioid medications based on a 10-item, investigator created, pre/post quiz (total score range of 1 to 10) designed to address key educational components of the app</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contingency Management - Virtual Pet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which can be used in the care of a virtual pet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contingency Management - Monetary</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which will be paid out at the end of the one-week trial in the form of a monetary reward.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prescription Opioid Management App</intervention_name>
    <description>Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal</description>
    <arm_group_label>Contingency Management - Monetary</arm_group_label>
    <arm_group_label>Contingency Management - Virtual Pet</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has current prescription for opioid medication&#xD;
&#xD;
          -  Any ethnic group&#xD;
&#xD;
          -  Served through the following programs of partnering organization: primary medical&#xD;
             care, transgender medical care, HIV and sexually transmitted infection (STI) screening&#xD;
             and counseling, LGBTQ services, pre-exposure prophylaxis and post exposure prophylaxis&#xD;
             services, health education, clinical research, case management, psychosocial services,&#xD;
             nutrition counseling, treatment adherence&#xD;
&#xD;
          -  Owns an Android-base smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Currently being treated for/history of mental health or substance use disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann D Bagchi, PhD,DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers, The State University of New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Jersey Community Research Initiative</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Ann D. Bagchi, PhD, DNP</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share individual participant data</ipd_description>
  </patient_data>
  <!-- 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/NCT04462250
org study id: Pro2020001699
nct id: NCT04462250
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A key driver of the current opioid overdose epidemic is the misuse of legitimately prescribed
      opioid medications. Patient education through use of mobile technology may help to increase
      knowledge of appropriate use of opioid medications; however, knowledge does not always
      translate into behavior modification. Therefore, there is a need for more research into
      patient-facing technology that can increase both knowledge and behaviors consistent with
      appropriate opioid use. These needs have been amplified by the severe acute respiratory
      syndrome coronavirus-2 (COVID-19) pandemic, which has exposed healthcare disparities,
      heightened the risk for mental and behavioral health disorders, and dramatically increased
      reliance on telehealth technologies. It is critically important that telehealth solutions be
      accessible and user-friendly for all consumers, particularly members of underserved
      communities with limited digital health literacy. This feasibility study will develop a
      mobile health app to improve appropriate use of opioid medications among patients with a
      prescription to treat non-cancer pain. The study will use focus groups with consumers and
      providers to determine the content and features to be included in the app and will test the
      feasibility of implementing a contingency management approach (i.e., rewards system) with the
      app using a randomized control trial. The key outcome of interest is confirmation of the
      design and operating specifications of the app, including the use of contingency management.
      Secondary outcomes of interest are the overall rating of the app and an increase in knowledge
      among users regarding the safe use, storage, and disposal of opioid medications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Device Feasibility
masking: Double (Participant, Investigator)
masking description: Participants will enter all data using a numeric identifier assigned by a third-party recruiter
measure: Device functionality
time frame: Assessed at the end of the one-week trial
description: Confirmation that the app features work as intended based on user input
measure: Mobile App Rating Scale (MARS)
time frame: Data collected through app and telephone interviews at the end of the one-week trial
description: Participants' assessment of functionality and utility of app with 19 items scored from 1 to 5 (overall score range 19 to 95) where higher scores indicate better app rating
measure: Change in knowledge quiz score
time frame: Change in score as assessed at the end of the one-week trial
description: Participants will show an increase in knowledge related to the safe used, storage, and disposal of opioid medications based on a 10-item, investigator created, pre/post quiz (total score range of 1 to 10) designed to address key educational components of the app
arm group label: Control
arm group type: Active Comparator
description: Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points but there will be no reward provided.
arm group label: Contingency Management - Virtual Pet
arm group type: Active Comparator
description: Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which can be used in the care of a virtual pet.
arm group label: Contingency Management - Monetary
arm group type: Active Comparator
description: Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which will be paid out at the end of the one-week trial in the form of a monetary reward.
intervention type: Device
intervention name: Prescription Opioid Management App
description: Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal
arm group label: Contingency Management - Monetary
arm group label: Contingency Management - Virtual Pet
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ann D Bagchi, PhD,DNP
role: Principal Investigator
affiliation: Rutgers, The State University of New Jersey
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Ann D. Bagchi, PhD, DNP
investigator title: Assistant Professor
mesh term: Analgesics, Opioid
sharing ipd: No
ipd description: There is no plan to share individual participant data