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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: myBETAapp; Other: PEAK; Drug: Betaferon, BAY86-5046; Device: BETACONNECT

• Registration Number: NCT03808142
• Lead Sponsor: Bayer

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Study Start: 2019-02-20
• Primary Completion: 2020-04-20
• Study Completion: 2020-09-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	PEAK	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).
Treatment	Betaferon, BAY86-5046	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).
Treatment	myBETAapp	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).
Treatment	BETACONNECT	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Relative proportion of injections missed per 3-month intervals	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019	Assessed retrospectively
Health-related quality of life assessed by questionnaire EQ-5D-5L	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.
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)	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".
Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)	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".
Compliance percentage to therapy	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019	Assessed retrospectively
Persistence percentage of therapy	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019	Assessed retrospectively
Adherence percentage to therapy	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019	Assessed retrospectively
Absolute number of injections missed per 3-month intervals	Retrospective analysis from 01-Sep-2015 to 15-Apr-2019	Assessed retrospectively
Response level of Satisfaction with the myBETAapp (service questionnaire)	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).
Feedback based on free text on supporting services or devices	Up to 12 months from informed consent provided	Single question
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

Trial Locations

Locations (1)

Many locations; 🇩🇪 Multiple Locations, Germany