Trial Condition(s):
Multiple Sclerosis
US PROmyBETAapp2.0: A study to learn more about the medication usage and patient reported outcomes via the myBETAapp in medical care of patients with multiple sclerosis treated with BETASERON using BETACONNECT autoinjector
Bayer Identifier:
20756
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
In this study researchers want to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with BETASERON using the myBETAapp. Multiple sclerosis (MS) is a disease in which the covering called "myelin" around the nerves of the central nervous system degenerate. MS is a lifelong disease therefore requiring continuous treatment to delay the disease progression and reduce the rate of relapse (the return of signs and symptoms of). BETASERON is an approved medicine used to reduce the relapse in patients with MS. It is injected into the tissue under the skin using BETACONNECT autoinjector, which automatically captures injection data including injection date, time, speed, and depth and uploads the data into paired myBETAapp. This allows patients to organize and track their progress and share the injection information with their physicians. The medication usage behavior to be collected in this study includes the elements to what extent
- taking medication matches the presciber′s recommendation (adherence, compliance),
- treatment for the prescribed duration (persistence) is continued and
- injections were missed.
Among MS patients treated with Betaferon using the myBETAapp the study will also collect information on the health-related quality of life , treatment satisfaction and satisfaction with treatment support.
Inclusion Criteria
- Aged ≥18 years - Treated with BETASERON using the BETACONNECT autoinjector - Registered with myBETAapp - Provided electronic informed consent
Exclusion Criteria
- There are no exclusion criteria for participation in this study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations myBETAapp Whippany, United States, 07981 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
US PROmyBETAapp2.0: Ascertaining medication usage and patient-reported outcomes (PROs) via the myBETAapp™ in patients with Multiple Sclerosis treated with BETASERON® using BETACONNECT™ autoinjector
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Compliance to therapyCompliance is defined as the the proportion of BETASERON administrations with the correct injection interval within some window. Windows will be set for each individual patient based on prescribed injection frequency.Timeframe: Up to 6 months
- Persistence of therapyPersistence to BETASERON using the BETACONNECT device will be measured as the number of days between the initial BETASERON administration and the earlier of the last BETASERON administration using the BETACONNECT device or before a minimum 60-day gap in therapy.Timeframe: Up to 6 months
- Adherence to therapyAdherence to BETASERON using the BETACONNECT device is a dichotomous variable (adherent or non-adherent) defined as receiving at least 80% of the expected number of injections during 6 months of treatment (or up to the point of early termination) as captured by the BETACONNECT device.Timeframe: Up to 6 months
Secondary Outcome
- Change in patient-reported health-related quality of life (HRQOL)Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.Timeframe: Up to 6 months
- Patient satisfaction with the myBETAappPatient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.Timeframe: Up to 6 months
- Change in health status evaluated by EQ-5D-5L descriptive systemEQ-5D-5L is a standardized measure of general health status. The EQ-5D-5L descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), where respondents indicate their health state on each dimension based on 5 response options (no problems, slight problems, moderate problems, severe problems, and extreme problems).Timeframe: Up to 6 months
- Change in EQ-Visual Analog Score (EQ-VAS)The EQ-Visual Analog Score (EQ-VAS) allows respondents to rate their health on a 20 cm vertical, visual analog scale with endpoints labelled ‘the best health you can imagine’ and ‘the worst health you can imagine’ and provides a single quantitative measure of health.Timeframe: Up to 6 months
- Change in prescription and non-prescription medication usagePrescription and non-prescription medication usage will be collected via an online study-specific patient survey.Timeframe: Up to 6 months
- Number of relapsesTimeframe: Up to 6 months
- Number of participants with treatment with corticosteroids due to relapsesTimeframe: Up to 6 months
- Number of emergency room visits due to relapseTimeframe: Up to 6 months
- Number of hospitalizations due to relapseTimeframe: Up to 6 months
- Patient self-assessmentSelf-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.Timeframe: Up to 6 months
- Change in dose of BETASERON prescriptionTimeframe: Up to 6 months
- Change in frequency of BETASERON prescriptionTimeframe: Up to 6 months
- Patient satisfaction with the BETACONNECT autoinjectorPatient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.Timeframe: Up to 6 months
Additional Information
Not Available
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