PROmyBETAappGame: a Study to Learn More About the Medication Usage & 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

• ClinicalTrials.gov Identifier: NCT03808142
• Recruitment Status: Completed
• First Posted: January 17, 2019
• Last Update Posted: August 25, 2021
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Multiple Sclerosis	Other: myBETAapp; Other: PEAK; Drug: Betaferon, BAY86-5046; Device: BETACONNECT

Detailed Description:

The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study

Study Design

• Study Type: Observational
• Actual Enrollment: 79 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: PROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon
• Actual Study Start Date: February 20, 2019
• Actual Primary Completion Date: April 20, 2020
• Actual Study Completion Date: September 2, 2020

Groups and Cohorts

Group/Cohort

Intervention/treatment

Treatment; 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).

Other: myBETAapp; 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.; Other: PEAK; Peak is an application that aims at helping its users to challenge their brains and keep them sharp.; Drug: Betaferon, BAY86-5046; Injection; Device: BETACONNECT; BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.

Outcome Measures

Primary Outcome Measures :

1. Compliance percentage to therapy [ Time Frame: Up to 12 months from informed consent provided ]
   Assessed prospectively
2. Persistence percentage of therapy [ Time Frame: Up to 12 months from informed consent provided ]
   Assessed prospectively
3. Adherence percentage to therapy, assessed prospectively [ Time Frame: Up to 12 months from informed consent provided ]
   Assessed prospectively
4. Absolute number of injections missed per 3-month intervals [ Time Frame: Up to 12 months from informed consent provided ]
   Assessed prospectively
5. Relative proportion of injections missed per 3-month intervals [ Time Frame: Up to 12 months from informed consent provided ]
   Assessed prospectively

Secondary Outcome Measures :

1. Compliance percentage to therapy [ Time Frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 ]
   Assessed retrospectively
2. Persistence percentage of therapy [ Time Frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 ]
   Assessed retrospectively
3. Adherence percentage to therapy [ Time Frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 ]
   Assessed retrospectively
4. Absolute number of injections missed per 3-month intervals [ Time Frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 ]
   Assessed retrospectively
5. Relative proportion of injections missed per 3-month intervals [ Time Frame: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019 ]
   Assessed retrospectively
6. Health-related quality of life assessed by questionnaire EQ-5D-5L [ Time Frame: Up to 12 months from informed consent provided ]

   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.

7. Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II) [ Time Frame: Up to 12 months from informed consent provided ]
8. Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire) [ Time Frame: Up to 12 months from informed consent provided ]
   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".
9. Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire) [ Time Frame: Up to 12 months from informed consent provided ]
   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".
10. Response level of Satisfaction with the myBETAapp (service questionnaire) [ Time Frame: Up to 12 months from informed consent provided ]
    This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied).
11. Feedback based on free text on supporting services or devices [ Time Frame: Up to 12 months from informed consent provided ]
    Single question
12. Number of MS patients using the mobile-based cognitive training tool - PEAK [ Time Frame: Up to 12 months from informed consent provided ]
13. Proportion of MS patients using the mobile-based cognitive training tool - PEAK [ Time Frame: Up to 12 months from informed consent provided ]
14. Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week) [ Time Frame: Up to 12 months from informed consent provided ]
15. Duration of mobile-based cognitive training tool - PEAK usage (days) [ Time Frame: Up to 12 months from informed consent provided ]
16. Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes) [ Time Frame: Up to 12 months from informed consent provided ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Women and men in Germany with the diagnosis of MS that were treated with Betaferon and used the myBETAapp were eligible to participate in the study. The option to enroll in the study was offered after log-in procedure to myBETAapp.

Criteria

Inclusion criteria

• Patients aged ≥ 18 years.
• Patients on treatment with Betaferon (every Betaferon box contains a "Mixject" number, which is a product specific number unrelated to the study. Only patients prescribed Betaferon for their MS will be able to use the myBETAapp and participate in the study).
• Patients must be using the myBETAapp.
• Electronic informed consent must be obtained.

Exclusion criteria

- No exclusion criteria for participation in this study were defined.

Contacts and Locations

Locations

Germany

Many locations

Multiple Locations, Germany

Sponsors and Collaborators

Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer products 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03808142
• Other Study ID Numbers: 20263
• First Posted: January 17, 2019
• Last Update Posted: August 25, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Plan 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Interferon beta-1b; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs