Clinical trial NCT02652091: Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
Official title: Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Adherence
Persistence
Patient satisfaction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-01-11
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS)

Brief summary: The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).

The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.


Eligibility criteria: Inclusion Criteria:

* Male and females greater than or equal to 18 years of age
* Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS)
* Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study)
* Confirmation of insurance coverage for BETASERON treatment
* Access to a personal computer to complete online patient satisfaction survey at Week 6

Exclusion Criteria:

* Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment
* Documented substance abuse within the previous 6 months prior to study enrollment
* Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study
* Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study
* Pregnant or nursing

Primary outcomes:
measure: Number of BETASERON injections as captured by the BETACONNECT device
timeFrame: At 6 months
measure: Time (days) between BETASERON injections as captured by BETACONNECT device
timeFrame: At 6 months
Secondary outcomes:
measure: Patient reported satisfaction by a questionnaire
timeFrame: At 6 weeks
Other outcomes:
Locations:
city: Cullman
country: United States
state: Alabama
city: Boca Raton
country: United States
state: Florida
city: New Port Richey
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Fulton
country: United States
state: Maryland
city: Foxboro
country: United States
state: Massachusetts
city: Deckerville
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Stratford
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Staten Island
country: United States
state: New York
city: Medford
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Bala-Cynwyd
country: United States
state: Pennsylvania
city: Lititz
country: United States
state: Pennsylvania
city: Franklin
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Lubbock
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: