PROmyBETAappGame: Ascertaining Medication Usage & Patient Reported Outcomes Via the myBETAapp and Exploring Gamification in Patients With Multiple Sclerosis Treated With Betaferon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Persistence percentage of therapy
研究概览
简要总结
In this study researchers wanted to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with Betaferon using the myBETAapp which includes the elements to what extent
- taking medication matched the presciber´s recommendation (adherence, compliance),
- treatment for the prescribed duration (persistence) was continued and
- injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study also collected information on the health-related quality of life, treatment satisfaction and satisfaction with treatment support.
详细描述
The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).
干预措施: myBETAapp (Other)
Treatment
During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).
干预措施: PEAK (Other)
Treatment
During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).
干预措施: Betaferon, BAY86-5046 (Drug)
Treatment
During a 3-months period all patients with an active myBETAapp account were invited to participate in the study (3-month invitation period=enrollment period). Patients seek more information about the study were able to access a detailed informed consent form via their app providing step-by-step background information. Those patients were wishing to participate in the study were able to provide (electronic) informed consent (ICF).
干预措施: BETACONNECT (Device)
结局指标
主要结局
Persistence percentage of therapy
时间窗: Up to 12 months from informed consent provided
Assessed prospectively
Relative proportion of injections missed per 3-month intervals
时间窗: Up to 12 months from informed consent provided
Assessed prospectively
Compliance percentage to therapy
时间窗: Up to 12 months from informed consent provided
Assessed prospectively
Adherence percentage to therapy, assessed prospectively
时间窗: Up to 12 months from informed consent provided
Assessed prospectively
Absolute number of injections missed per 3-month intervals
时间窗: Up to 12 months from informed consent provided
Assessed prospectively
次要结局
- Scores of Treatment Satisfaction Questionnaire for Medication version 2 (TSQM v.II)(Up to 12 months from informed consent provided)
- Response level of Satisfaction with the BETAPLUS patient support program (service questionnaire)(Up to 12 months from informed consent provided)
- Relative proportion of injections missed per 3-month intervals(Retrospective analysis from 01-Sep-2015 to 15-Apr-2019)
- Health-related quality of life assessed by questionnaire EQ-5D-5L(Up to 12 months from informed consent provided)
- Response level of Satisfaction with the BETACONNECT autoinjector (service questionnaire)(Up to 12 months from informed consent provided)
- Compliance percentage to therapy(Retrospective analysis from 01-Sep-2015 to 15-Apr-2019)
- Persistence percentage of therapy(Retrospective analysis from 01-Sep-2015 to 15-Apr-2019)
- Adherence percentage to therapy(Retrospective analysis from 01-Sep-2015 to 15-Apr-2019)
- Absolute number of injections missed per 3-month intervals(Retrospective analysis from 01-Sep-2015 to 15-Apr-2019)
- Response level of Satisfaction with the myBETAapp (service questionnaire)(Up to 12 months from informed consent provided)
- Feedback based on free text on supporting services or devices(Up to 12 months from informed consent provided)
- Number of MS patients using the mobile-based cognitive training tool - PEAK(Up to 12 months from informed consent provided)
- Proportion of MS patients using the mobile-based cognitive training tool - PEAK(Up to 12 months from informed consent provided)
- Frequency of mobile-based cognitive training tool - PEAK usage (trainings/week)(Up to 12 months from informed consent provided)
- Duration of mobile-based cognitive training tool - PEAK usage (days)(Up to 12 months from informed consent provided)
- Cumulative time played per game of mobile-based cognitive training tool - PEAK usage (minutes)(Up to 12 months from informed consent provided)