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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356339
• Other study ID #: 20756
• Status: Completed
• Start date: November 24, 2020
• Est. completion date: November 11, 2021

Study information

• Verified date: July 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 11, 2021
• Est. primary completion date: August 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-beta-1b (BETASERON, BAY 86-5046)
Using the BETACONNECT autoinjector and myBETAapp as prescribed by the physician

Locations

Country	Name	City	State
United States	myBETAapp	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance to therapy	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.	Up to 6 months
Primary	Persistence of therapy	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.	Up to 6 months
Primary	Adherence to therapy	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	Patient satisfaction with the myBETAapp	Patient satisfaction with the myBETAapp will be collected via an online study-specific patient survey.	Up to 6 months
Secondary	Change in health status evaluated by EQ-5D-5L descriptive system	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).	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	Change in prescription and non-prescription medication usage	Prescription and non-prescription medication usage will be collected via an online study-specific patient survey.	Up to 6 months
Secondary	Number of relapses		Up to 6 months
Secondary	Number of participants with treatment with corticosteroids due to relapses		Up to 6 months
Secondary	Number of emergency room visits due to relapse		Up to 6 months
Secondary	Number of hospitalizations due to relapse		Up to 6 months
Secondary	Patient self-assessment	Self-assessment includes assessment for mood, memory, vision, urinary symptoms. The assessment will be collected via an online study-specific patient survey.	Up to 6 months
Secondary	Change in dose of BETASERON prescription		Up to 6 months
Secondary	Change in frequency of BETASERON prescription		Up to 6 months
Secondary	Patient satisfaction with the BETACONNECT autoinjector	Patient satisfaction with the BETACONNECT autoinjector will be collected via an online study-specific patient survey.	Up to 6 months