Multiple SclerosisPROmyBETAappNCT03134573
Medication Usage and Patient Reported Outcomes Evaluation Via myBETAapp in Patients With Multiple Sclerosis Treated With Betaferon: a Pilot Study
An observational study of Multiple Sclerosis, run by Bayer at 1 site in Germany.
Trial summary
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. 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?
- Interferon beta-1b (Betaferon, BAY86-5046), Betaconnect auto-injector and myBETAapp
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- 15 Sep 2017to 9 May 2018
- 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: The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the 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
- -There are no exclusion criteria for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1b (Betaferon, BAY86-5046), Betaconnect auto-injector, myBETAapp
- Keywords
- Relapsing Remitting Multiple Sclerosis (RRMS),, Clinically isolated Syndrome (CIS),, Secondary Progressive Multiple Sclerosis (SPMS)
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Carcinoma in Situ, Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaferon, BAY86-5046)Drug
Solution for injection
Betaconnect auto-injectorDevice
Auto-injector for application of Betaferon solution which automatically covers injection related data
myBETAappDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Women and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp Receives: Drug: Interferon beta-1b (Betaferon, BAY86-5046); Device: Betaconnect auto-injector; Device: myBETAapp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance to therapy (%)
Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100
Measured: 6 months
Persistence of therapy (yes, no)
Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)
Measured: 6 months
Adherence to therapy (yes, no)
Patients will be defined as being adherent to therapy if they fulfill the following criteria:
- They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and
- They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)
Measured: 6 months
Secondary outcomes (2)
Proportion of patients consenting to participate in this study among those using the myBETAapp
All patients registering their myBETAapp will be asked to participate in the study. Patients consenting to participate in the study will be flagged in the database. The proportion of patients consenting will then be calculated by dividing the number of patients giving consent by all patients asked.
Measured: 3 months
Proportion of patients volunteering to record wellness related data in each of the following categories on the "Wellness chart" on the myBETAapp
Wellness Chart:(1) ability to walk, (2) coordination, (3) energy level, (4) bladder control, (5) exercise level,(6) memory, (7) vision, (8) bowel control, (9) emotions, and (10) eating habits
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start15 Sep 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134573
- Sponsor's protocol ID
- 18462
- Other IDs
- BF1504
- Acronym
- PROmyBETAapp
- Status last verified
- Mar 2019
- First submitted
- 26 Apr 2017
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31359863
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROmyBETAapp: Ascertaining Medication Usage & Documentation of Patient Reported Outcomes Utilizing the myBETAapp® in Patients With Multiple Sclerosis Treated With Betaferon®: a Pilot Study
- ClinicalTrials.gov ID
- NCT03134573
- Acronym / sponsor ID
- PROmyBETAapp / 18462
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Remitting Multiple Sclerosis (RRMS),, Clinically isolated Syndrome (CIS),, Secondary Progressive Multiple Sclerosis (SPMS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | – | Drug: Interferon beta-1b (Betaferon, BAY86-5046), Device: Betaconnect auto-injector, Device: myBETAappWomen and men in Germany with the diagnosis of MS that are treated with Betaferon and use the myBETAapp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with multiple sclerosis who are treated with Betaferon and who are using the myBETAapp.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -There are no exclusion criteria for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon beta-1b (Betaferon, BAY86-5046)Solution for injection | Drug | Multiple Sclerosis |
| Betaconnect auto-injectorAuto-injector for application of Betaferon solution which automatically covers injection related data | Device | Multiple Sclerosis |
| myBETAappMedical 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 | Device | Multiple Sclerosis |
Primary outcome
Compliance to therapy (%)
Time frame: 6 months
Compliance (%) = ((true # of treatment days as derived from the data stored in the BETACONNECT)/(expected # of treatment days during observation period based on the injection frequency stipulated by the label))x100
Persistence of therapy (yes, no)
Time frame: 6 months
Persistence will be evaluated from the day of the first injection recorded in the BETACONNECT until the day of the last recorded injection or the end of observation (whichever comes first)
Adherence to therapy (yes, no)
Time frame: 6 months
Patients will be defined as being adherent to therapy if they fulfill the following criteria: 1. They have been at least 80% compliant, i.e. applied ≥80% of the expected Betaferon injections and 2. They have not dropped out of the study prior to the time of evaluation (i.e. they did not (1) stop using the myBETAapp or (2) withdraw their consent to participate in the study)
2 secondary outcomes
Proportion of patients consenting to participate in this study among those using the myBETAapp
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Derived from this study: PubMed 31359863Limmroth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
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 26 Mar 2019. 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 to therapy (%) (time frame: 6 months). The study lists 3 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 NCT03134573, which also lists 1 linked publication.
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 26 Mar 2019.