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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808142
• Other study ID #: 20263
• Status: Completed
• Start date: February 20, 2019
• Est. completion date: September 2, 2020

Study information

• Verified date: August 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: September 2, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance percentage to therapy	Assessed prospectively	Up to 12 months from informed consent provided
Primary	Persistence percentage of therapy	Assessed prospectively	Up to 12 months from informed consent provided
Primary	Adherence percentage to therapy, assessed prospectively	Assessed prospectively	Up to 12 months from informed consent provided
Primary	Absolute number of injections missed per 3-month intervals	Assessed prospectively	Up to 12 months from informed consent provided
Primary	Relative proportion of injections missed per 3-month intervals	Assessed prospectively	Up to 12 months from informed consent provided
Secondary	Compliance percentage to therapy	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Secondary	Persistence percentage of therapy	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Secondary	Adherence percentage to therapy	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Secondary	Absolute number of injections missed per 3-month intervals	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Secondary	Relative proportion of injections missed per 3-month intervals	Assessed retrospectively	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019
Secondary	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
Secondary	Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)		Up to 12 months from informed consent provided
Secondary	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
Secondary	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
Secondary	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
Secondary	Feedback based on free text on supporting services or devices	Single question	Up to 12 months from informed consent provided
Secondary	Number of MS patients using the mobile-based cognitive training tool - PEAK		Up to 12 months from informed consent provided
Secondary	Proportion of MS patients using the mobile-based cognitive training tool - PEAK		Up to 12 months from informed consent provided
Secondary	Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)		Up to 12 months from informed consent provided
Secondary	Duration of mobile-based cognitive training tool - PEAK usage (days)		Up to 12 months from informed consent provided
Secondary	Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)		Up to 12 months from informed consent provided

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