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Multiple SclerosisNCT03808142

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

An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
myBETAapp, PEAK and Betaferon, BAY86-5046
How many people
79 participants
Where
1 siteGermany
Study dates
20 Feb 2019to 2 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Many locations

    Multiple Locations

Other trials in Germany

About this study

Official title: 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.
Read the detailed description

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

Being tested
myBETAapp, PEAK, Betaferon, BAY86-5046, BETACONNECT
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • myBETAappOther

    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.

  • PEAKOther

    Peak is an application that aims at helping its users to challenge their brains and keep them sharp.

  • Betaferon, BAY86-5046Drug

    Injection

  • BETACONNECTDevice

    BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.

Study groups in NCT03808142
Study groupRoleWhat they receive
TreatmentDuring 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).
Receives: Other: myBETAapp; Other: PEAK; Drug: Betaferon, BAY86-5046; Device: BETACONNECT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance percentage to therapy

    Assessed prospectively

    Measured: Up to 12 months from informed consent provided

  2. Persistence percentage of therapy

    Assessed prospectively

    Measured: Up to 12 months from informed consent provided

  3. Adherence percentage to therapy, assessed prospectively

    Assessed prospectively

    Measured: Up to 12 months from informed consent provided

  4. Absolute number of injections missed per 3-month intervals

    Assessed prospectively

    Measured: Up to 12 months from informed consent provided

  5. Relative proportion of injections missed per 3-month intervals

    Assessed prospectively

    Measured: Up to 12 months from informed consent provided

Secondary outcomes (16)

  1. Compliance percentage to therapy

    Assessed retrospectively

    Measured: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

  2. Persistence percentage of therapy

    Assessed retrospectively

    Measured: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

  3. Adherence percentage to therapy

    Assessed retrospectively

    Measured: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

  4. Absolute number of injections missed per 3-month intervals

    Assessed retrospectively

    Measured: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

  5. Relative proportion of injections missed per 3-month intervals

    Assessed retrospectively

    Measured: Retrospective analysis from 01-Sep-2015 to 15-Apr-2019

  6. 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.

    Measured: Up to 12 months from informed consent provided

  7. Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)

    Measured: Up to 12 months from informed consent provided

  8. 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".

    Measured: Up to 12 months from informed consent provided

  9. 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".

    Measured: Up to 12 months from informed consent provided

  10. 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).

    Measured: Up to 12 months from informed consent provided

  11. Feedback based on free text on supporting services or devices

    Single question

    Measured: Up to 12 months from informed consent provided

  12. Number of MS patients using the mobile-based cognitive training tool - PEAK

    Measured: Up to 12 months from informed consent provided

  13. Proportion of MS patients using the mobile-based cognitive training tool - PEAK

    Measured: Up to 12 months from informed consent provided

  14. Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)

    Measured: Up to 12 months from informed consent provided

  15. Duration of mobile-based cognitive training tool - PEAK usage (days)

    Measured: Up to 12 months from informed consent provided

  16. Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)

    Measured: Up to 12 months from informed consent provided

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2019
  2. Study start20 Feb 2019
  3. Primary completion20 Apr 2020
  4. Study completion2 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03808142
Sponsor's protocol ID
20263
Status last verified
Aug 2021
First submitted
10 Jan 2019
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance percentage to therapy (time frame: Up to 12 months from informed consent provided). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03808142.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.

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Clinical Trial NCT03808142 | AzTrials