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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Interferon-beta-1b (BETASERON, BAY 86-5046)

• Registration Number: NCT04356339
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-19
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-22
• Study Start: 2020-11-24
• Primary Completion: 2021-08-29
• Study Completion: 2021-11-11
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BETASERON	Interferon-beta-1b (BETASERON, BAY 86-5046)	Participants with Multiple Sclerosis treated with BETASERON using BETACONNECT autoinjector and myBETAapp will be enrolled

Primary Outcome Measures

Name	Time	Method
Compliance to therapy	Up to 6 months	Compliance 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.
Persistence of therapy	Up to 6 months	Persistence 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.
Adherence to therapy	Up to 6 months	Adherence 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.

Secondary Outcome Measures

Name	Time	Method
Number of emergency room visits due to relapse	Up to 6 months
Change in dose of BETASERON prescription	Up to 6 months
Number of hospitalizations due to relapse	Up to 6 months
Change in frequency of BETASERON prescription	Up to 6 months
Patient satisfaction with the BETACONNECT autoinjector	Up to 6 months	Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.
Change in patient-reported health-related quality of life (HRQOL)	Up to 6 months	Change in patient-reported health-related quality of life (HRQOL) will be collected via an online study-specific patient survey.
Change in prescription and non-prescription medication usage	Up to 6 months	Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.
Number of participants with treatment with corticosteroids due to relapses	Up to 6 months
Number of relapses	Up to 6 months
Patient satisfaction with the myBETAapp	Up to 6 months	Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.
Change in EQ-Visual Analog Score (EQ-VAS)	Up to 6 months	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.
Patient self-assessment	Up to 6 months	Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.
Change in health status evaluated by EQ-5D-5L descriptive system	Up to 6 months	EQ-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).

Trial Locations

Locations (1)

myBETAapp; 🇺🇸 Whippany, New Jersey, United States