Observational Study Evaluating the Physical Activity in a Subset of Damoctocog Alfa Pegol Treated Hemophilia A Patients Who Are Enrolled in the HEM-POWR Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Category of physical non-sedentary activity
研究概览
简要总结
In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient's clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients.
The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.
详细描述
The primary objective is to evaluate the change in physical non-sedentary activity as measured by the ActiGraph CentrePoint Insight Watch (ActiGraph LLC, Pensacola, Florida) after 1, 2 and 3 years of treatment with damoctocog alfa pegol.
Secondary objectives are to determine the
- Change in intensity of physical activity,
- Association between physical activities and clinical outcomes / patient-reported outcome scores/ number of bleeds,
- Percentage of patients achieving WHO-recommended levels of activity
- Actual wear time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the HEM-POWR study (NCT03932201)
- •Naïve to damoctocog alfa pegol prior to enrollment to HEM-POWR study
- •Prescribed for prophylaxis treatment for hemophilia with damoctocog alfa pegol
- •Patient is willing to wear the provided device
- •Signed informed consent/assent to participate in LIFE-ACTIVE: Observational study evaluating the physical activity in a subset of damoctocog alfa pegol treated Hemophilia A patients who are enrolled in the HEM-POWR study
排除标准
- •Hypersensitivity to any material of activity monitor (e.g. steel, rubber)
- •Time gap between enrollment to HEM-POWR study and enrollment to LIFE-ACTIVE study is greater than 6 months
研究组 & 干预措施
Hemophilia A patients
Patients with hemophilia A who are being treated with Damoctocog alfa pegol (Jivi, BAY94-9027) in routine medical practice and are enrolled in Bayer-sponsored study NCT03932201
干预措施: Damoctocog alfa pegol (Jivi, BAY94-9027) (Drug)
结局指标
主要结局
Category of physical non-sedentary activity
时间窗: 30 days at year 3
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time of physical non-sedentary activity per week
时间窗: 30 days at year 3
次要结局
- Actual wear time per week(30 days at each visit (baseline, year 1, 2 and 3))
- Percentage of children (under 18) with ≥60 min per day of moderate to vigorous intensity physical activity(30 days at each visit (baseline, year 1, 2 and 3))
- Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR)(30 days at each visit (baseline, year 1, 2 and 3))
- Time of physical activity per week by intensity stratified by sedentary and locomotion activity(30 days at each visit (baseline, year 1, 2 and 3))
- Association between physical activity time per week and hemophilia joint health score (HJHS)(30 days at each visit (baseline, year 1, 2 and 3))
- Association between physical activity time per week and PRO-scores for treatment satisfaction(30 days at each visit (baseline, year 1, 2 and 3))
- Association between physical activity time per week and PRO-scores for health-related life quality(30 days at each visit (baseline, year 1, 2 and 3))
- Association between physical activity time per week and annualized bleeding rate (ABR)(30 days at each visit (baseline, year 1, 2 and 3))
- Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR)(30 days at each visit (baseline, year 1, 2 and 3))
- Percentage of actual wear time per week(30 days at each visit (baseline, year 1, 2 and 3))
- Percentage of adults (age 18 to 64) with ≥150 min per week of moderate to vigorous intensity physical activity or with ≥75 min per week of vigorous intensity physical activity(30 days at each visit (baseline, year 1, 2 and 3))
- Time of physical activity per week by intensity(30 days at each visit (baseline, year 1, 2 and 3))
- Association between physical activity time per week and joint annualized bleeding rate (JABR)(30 days at each visit (baseline, year 1, 2 and 3))
- Association between physical activity time per week and PRO-scores for work productivity/ activity impairment(30 days at each visit (baseline, year 1, 2 and 3))