Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study

NCT ID: NCT03134573

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2018-05-09

Brief Summary

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The planned study will be a prospective, non-interventional, observational cohort study using the structure of a registry. Medication usage behavior will be observed for 6 months, while documentation behavior on the wellness tracker in the myBETAapp will be observed for 3 months.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Sclerosis

Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp

Interferon beta-1b (Betaferon, BAY86-5046)

Intervention Type DRUG

Solution for injection

Betaconnect auto-injector

Intervention Type DEVICE

Auto-injector for application of Betaferon solution which automatically covers injection related data

myBETAapp

Intervention Type DEVICE

Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker

Interventions

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Interferon beta-1b (Betaferon, BAY86-5046)

Solution for injection

Intervention Type DRUG

Betaconnect auto-injector

Auto-injector for application of Betaferon solution which automatically covers injection related data

Intervention Type DEVICE

myBETAapp

Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many locations

Multiple Locations, , Germany

Site Status

Countries

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Germany

References

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Limmroth V, Hechenbichler K, Muller C, Schurks M. Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp). J Med Internet Res. 2019 Jul 29;21(7):e14373. doi: 10.2196/14373.

Reference Type DERIVED
PMID: 31359863 (View on PubMed)

Related Links

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https://clinicaltrials.bayer.com/

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

Other Identifiers

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BF1504

Identifier Type: OTHER

Identifier Source: secondary_id

18462

Identifier Type: -

Identifier Source: org_study_id

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