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.
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.
Study Type
OBSERVATIONAL
Enrollment
10
Intervention is given as part of routine medical practice
Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
Orange, California, United States
Tulane University
New Orleans, Louisiana, United States
Many Locations
Multiple Locations, Belgium
Many Locations
Multiple Locations, Canada
Many Locations
Multiple Locations, Italy
Many Locations
Multiple Locations, Slovenia
Many Locations
Multiple Locations, Spain
Many Locations
Multiple Locations, Taiwan
Time of physical non-sedentary activity per week
Time frame: 30 days at baseline
Time of physical non-sedentary activity per week
Time frame: 30 days at year 1
Time of physical non-sedentary activity per week
Time frame: 30 days at year 2
Time of physical non-sedentary activity per week
Time frame: 30 days at year 3
Category of physical non-sedentary activity
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time frame: 30 days at baseline
Category of physical non-sedentary activity
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time frame: 30 days at year 1
Category of physical non-sedentary activity
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time frame: 30 days at year 2
Category of physical non-sedentary activity
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time frame: 30 days at year 3
Time of physical activity per week by intensity
Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time frame: 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
Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Association between physical activity time per week and annualized bleeding rate (ABR)
ABR from HEM-POWR study
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Association between physical activity time per week and joint annualized bleeding rate (JABR)
JABR from HEM-POWR study
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Association between physical activity time per week and hemophilia joint health score (HJHS)
HJHS from HEM-POWR study
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Association between physical activity time per week and PRO-scores for treatment satisfaction
Patient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR study
Time frame: 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
Patient reported outcome (PRO) scores from the Hemophilia Quality Life Measures for adults and Hemophilia Quality of Life short form for children questionnaires collected in HEM-POWR study
Time frame: 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
Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study
Time frame: 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
Time frame: 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
Time frame: 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)
ABR from HEM-POWR study
Time frame: 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)
JABR from HEM-POWR study
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Actual wear time per week
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Percentage of actual wear time per week
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
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