Hemophilia A
Conditions
Keywords
Physical activity, Coagulation factor VIII, Joint health
Brief summary
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.
Detailed description
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.
Interventions
Intervention is given as part of routine medical practice
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of physical non-sedentary activity per week | 30 days at baseline | — |
| Category of physical non-sedentary activity | 30 days at baseline | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between physical activity time per week and annualized bleeding rate (ABR) | 30 days at each visit (baseline, year 1, 2 and 3) | ABR from HEM-POWR study |
| Association between physical activity time per week and joint annualized bleeding rate (JABR) | 30 days at each visit (baseline, year 1, 2 and 3) | JABR from HEM-POWR study |
| Association between physical activity time per week and hemophilia joint health score (HJHS) | 30 days at each visit (baseline, year 1, 2 and 3) | HJHS from HEM-POWR study |
| Association between physical activity time per week and PRO-scores for treatment satisfaction | 30 days at each visit (baseline, year 1, 2 and 3) | Patient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR study |
| 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) | 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 |
| 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) | Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study |
| Time of physical activity per week by intensity | 30 days at each visit (baseline, year 1, 2 and 3) | Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity |
| 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) | — |
| 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) | ABR from HEM-POWR study |
| 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) | JABR from HEM-POWR study |
| Actual wear time per week | 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 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) | — |
| 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) | Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no |
Countries
Belgium, Canada, Italy, Slovenia, Spain, Taiwan, United States
Outcome results
None listed