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

PROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance percentage to therapy	Assessed prospectively	Up to 12 months from informed consent provided
Persistence percentage of therapy	Assessed prospectively	Up to 12 months from informed consent provided
Adherence percentage to therapy, assessed prospectively	Assessed prospectively	Up to 12 months from informed consent provided
Absolute number of injections missed per 3-month intervals	Assessed prospectively	Up to 12 months from informed consent provided
Relative proportion of injections missed per 3-month intervals	Assessed prospectively	Up to 12 months from informed consent provided

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance percentage to therapy	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Persistence percentage of therapy	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Adherence percentage to therapy	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Absolute number of injections missed per 3-month intervals	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Relative proportion of injections missed per 3-month intervals	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Health-related quality of life assessed by questionnaire EQ-5D-5L	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.	Up to 12 months from informed consent provided
Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)		Up to 12 months from informed consent provided
Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire)	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".	Up to 12 months from informed consent provided
Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)	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".	Up to 12 months from informed consent provided
Response level of Satisfaction with the myBETAapp (service questionnaire)	This question can be answered on a 5-point Likert Scale (Very satisfied/satisfied/neither satisfied nor dissatisfied/ dissatisfied/ very dissatisfied).	Up to 12 months from informed consent provided
Feedback based on free text on supporting services or devices	Single question	Up to 12 months from informed consent provided
Number of MS patients using the mobile-based cognitive training tool - PEAK		Up to 12 months from informed consent provided
Proportion of MS patients using the mobile-based cognitive training tool - PEAK		Up to 12 months from informed consent provided
Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)		Up to 12 months from informed consent provided
Duration of mobile-based cognitive training tool - PEAK usage (days)		Up to 12 months from informed consent provided
Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)		Up to 12 months from informed consent provided

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): September 2, 2020

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Interferon beta-1b
• Other Study ID Numbers: 20263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No