<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/NCT03808142</url>
  </required_header>
  <id_info>
    <org_study_id>20263</org_study_id>
    <nct_id>NCT03808142</nct_id>
  </id_info>
  <brief_title>PROmyBETAappGame: a Study to Learn More About the Medication Usage &amp; Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With Betaferon</brief_title>
  <official_title>PROmyBETAappGame: Ascertaining Medication Usage &amp; Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study researchers wanted to learn more about the medication usage behavior among&#xD;
      multiple sclerosis (MS) patients treated with Betaferon using the myBETAapp which includes&#xD;
      the elements to what extent&#xD;
&#xD;
        -  taking medication matched the presciber´s recommendation (adherence, compliance),&#xD;
&#xD;
        -  treatment for the prescribed duration (persistence) was continued and&#xD;
&#xD;
        -  injections were missed. Among MS patients treated with Betaferon using the myBETAapp the&#xD;
           study also collected information on the health-related quality of life, treatment&#xD;
           satisfaction and satisfaction with treatment support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional,&#xD;
      observational cohort study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">September 2, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance percentage to therapy</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Assessed prospectively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Persistence percentage of therapy</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Assessed prospectively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence percentage to therapy, assessed prospectively</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Assessed prospectively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute number of injections missed per 3-month intervals</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Assessed prospectively</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative proportion of injections missed per 3-month intervals</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Assessed prospectively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance percentage to therapy</measure>
    <time_frame>Retrospective analysis from 01-Sep-2015 to 15-Apr-2019</time_frame>
    <description>Assessed retrospectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistence percentage of therapy</measure>
    <time_frame>Retrospective analysis from 01-Sep-2015 to 15-Apr-2019</time_frame>
    <description>Assessed retrospectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence percentage to therapy</measure>
    <time_frame>Retrospective analysis from 01-Sep-2015 to 15-Apr-2019</time_frame>
    <description>Assessed retrospectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute number of injections missed per 3-month intervals</measure>
    <time_frame>Retrospective analysis from 01-Sep-2015 to 15-Apr-2019</time_frame>
    <description>Assessed retrospectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative proportion of injections missed per 3-month intervals</measure>
    <time_frame>Retrospective analysis from 01-Sep-2015 to 15-Apr-2019</time_frame>
    <description>Assessed retrospectively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life assessed by questionnaire EQ-5D-5L</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.&#xD;
Each dimension has 5 levels: (1) no problems , (2) slight problems, (3) moderate problems, (4) severe problems and (5) extreme problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied) also including the option &quot;not participating&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied) also including the option &quot;not using&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response level of Satisfaction with the myBETAapp (service questionnaire)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feedback based on free text on supporting services or devices</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
    <description>Single question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of MS patients using the mobile-based cognitive training tool - PEAK</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of MS patients using the mobile-based cognitive training tool - PEAK</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mobile-based cognitive training tool - PEAK usage (days)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)</measure>
    <time_frame>Up to 12 months from informed consent provided</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">79</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <description>During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>myBETAapp</intervention_name>
    <description>Patients choosing to use the myBETAapp were required to insert the Mixject number from their prescribed Betaferon box, which serves as an opening key for the app. Obtaining a new Betaferon box and obtaining a new Mixject number was not interfere with the process of continuously allocating data to a single patient; each patient had a unique personal identifier in the database. All data recorded in the myBETAapp including demographic and injection-related data were stored in the database once the mobile device was connected to the internet.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEAK</intervention_name>
    <description>Peak is an application that aims at helping its users to challenge their brains and keep them sharp.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betaferon, BAY86-5046</intervention_name>
    <description>Injection</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BETACONNECT</intervention_name>
    <description>BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women and men in Germany with the diagnosis of MS that were treated with Betaferon and used&#xD;
        the myBETAapp were eligible to participate in the study. The option to enroll in the study&#xD;
        was offered after log-in procedure to myBETAapp.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Patients aged ≥ 18 years.&#xD;
&#xD;
          -  Patients on treatment with Betaferon (every Betaferon box contains a &quot;Mixject&quot; number,&#xD;
             which is a product specific number unrelated to the study. Only patients prescribed&#xD;
             Betaferon for their MS will be able to use the myBETAapp and participate in the&#xD;
             study).&#xD;
&#xD;
          -  Patients must be using the myBETAapp.&#xD;
&#xD;
          -  Electronic informed consent must be obtained.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        - No exclusion criteria for participation in this study were defined.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 20, 2021</last_update_submitted>
  <last_update_submitted_qc>August 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferon beta-1b</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access.&#xD;
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.&#xD;
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</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/NCT03808142
org study id: 20263
nct id: NCT03808142
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study researchers wanted to learn more about the medication usage behavior among
      multiple sclerosis (MS) patients treated with Betaferon using the myBETAapp which includes
      the elements to what extent

        -  taking medication matched the presciber´s recommendation (adherence, compliance),

        -  treatment for the prescribed duration (persistence) was continued and

        -  injections were missed. Among MS patients treated with Betaferon using the myBETAapp the
           study also collected information on the health-related quality of life, treatment
           satisfaction and satisfaction with treatment support.
The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional,
      observational cohort study
observational model: Cohort
time perspective: Other
measure: Compliance percentage to therapy
time frame: Up to 12 months from informed consent provided
description: Assessed prospectively
measure: Persistence percentage of therapy
time frame: Up to 12 months from informed consent provided
description: Assessed prospectively
measure: Adherence percentage to therapy, assessed prospectively
time frame: Up to 12 months from informed consent provided
description: Assessed prospectively
measure: Absolute number of injections missed per 3-month intervals
time frame: Up to 12 months from informed consent provided
description: Assessed prospectively
measure: Relative proportion of injections missed per 3-month intervals
time frame: Up to 12 months from informed consent provided
description: Assessed prospectively
measure: Compliance percentage to therapy
time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
description: Assessed retrospectively
measure: Persistence percentage of therapy
time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
description: Assessed retrospectively
measure: Adherence percentage to therapy
time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
description: Assessed retrospectively
measure: Absolute number of injections missed per 3-month intervals
time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
description: Assessed retrospectively
measure: Relative proportion of injections missed per 3-month intervals
time frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
description: Assessed retrospectively
measure: Health-related quality of life assessed by questionnaire EQ-5D-5L
time frame: Up to 12 months from informed consent provided
description: Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: (1) no problems , (2) slight problems, (3) moderate problems, (4) severe problems and (5) extreme problems.
measure: Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)
time frame: Up to 12 months from informed consent provided
measure: Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire)
time frame: Up to 12 months from informed consent provided
description: This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied) also including the option "not participating".
measure: Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)
time frame: Up to 12 months from informed consent provided
description: This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied) also including the option "not using".
measure: Response level of Satisfaction with the myBETAapp (service questionnaire)
time frame: Up to 12 months from informed consent provided
description: This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied).
measure: Feedback based on free text on supporting services or devices
time frame: Up to 12 months from informed consent provided
description: Single question
measure: Number of MS patients using the mobile-based cognitive training tool - PEAK
time frame: Up to 12 months from informed consent provided
measure: Proportion of MS patients using the mobile-based cognitive training tool - PEAK
time frame: Up to 12 months from informed consent provided
measure: Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)
time frame: Up to 12 months from informed consent provided
measure: Duration of mobile-based cognitive training tool - PEAK usage (days)
time frame: Up to 12 months from informed consent provided
measure: Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)
time frame: Up to 12 months from informed consent provided
arm group label: Treatment
description: During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).
intervention type: Other
intervention name: myBETAapp
description: Patients choosing to use the myBETAapp were required to insert the Mixject number from their prescribed Betaferon box, which serves as an opening key for the app. Obtaining a new Betaferon box and obtaining a new Mixject number was not interfere with the process of continuously allocating data to a single patient; each patient had a unique personal identifier in the database. All data recorded in the myBETAapp including demographic and injection-related data were stored in the database once the mobile device was connected to the internet.
arm group label: Treatment
intervention type: Other
intervention name: PEAK
description: Peak is an application that aims at helping its users to challenge their brains and keep them sharp.
arm group label: Treatment
intervention type: Drug
intervention name: Betaferon, BAY86-5046
description: Injection
arm group label: Treatment
intervention type: Device
intervention name: BETACONNECT
description: BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.
arm group label: Treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Interferon beta-1b
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.