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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03134573 |
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Date of registration:
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26/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study
PROmyBETAapp |
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Scientific title:
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PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study |
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Date of first enrolment:
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September 15, 2017 |
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Target sample size:
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96 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03134573 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion 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.
Exclusion Criteria:
-There are no exclusion criteria for participation in this study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Device: Betaconnect auto-injector
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Device: myBETAapp
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Drug: Interferon beta-1b (Betaferon, BAY86-5046)
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Primary Outcome(s)
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Adherence to therapy (yes, no)
[Time Frame: 6 months]
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Compliance to therapy (%)
[Time Frame: 6 months]
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Persistence of therapy (yes, no)
[Time Frame: 6 months]
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Secondary Outcome(s)
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Proportion of patients consenting to participate in this study among those using the myBETAapp
[Time Frame: 3 months]
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Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp
[Time Frame: 3 months]
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Secondary ID(s)
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BF1504
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18462
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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