Patient Reported Outcomes Burdens and Experiences - Phase 2 (PROBE)
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ClinicalTrials.gov Identifier: NCT02439710 |
Recruitment Status :
Completed
First Posted : May 12, 2015
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
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Sponsor:
McMaster University
Collaborator:
National Hemophilia Foundation
Information provided by (Responsible Party):
McMaster University
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Study Type | Observational |
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Study Design | Observational Model: Other; Time Perspective: Prospective |
Condition |
Hemophilia |
Intervention |
Other: Quality of life measure (survey) |
Enrollment | 656 |
Participant Flow
Recruitment Details | Participants were recruited through NGOs utilizing their existing membership rosters, social media outlets and meetings or events. |
Pre-assignment Details | Participants were required to meet one of two inclusion criteria: (1) PWH (haemophilia A or B with any degree of disease severity) or (2) "Controls" (individuals with no bleeding disorders) |
Arm/Group Title | Enrolled Participants |
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"Patients with hemophilia" (haemophilia A or B with any degree of disease severity) or "Controls" (individuals with no bleeding disorders) |
Period Title: Overall Study | |
Started | 656 |
Completed | 656 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Enrolled Population | |
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Patients with hemophilia A or hemophilia B with any degree of disease severity or controls | |
Overall Number of Baseline Participants | 656 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 656 participants | |
41.9 (17.0) | ||
Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 646 participants | |
Female |
454 70.3%
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Male |
192 29.7%
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[1]
Measure Analysis Population Description: Missing data
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | |
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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Argentina | Number Analyzed | 656 participants |
35 5.3%
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Australia | Number Analyzed | 656 participants |
39 5.9%
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Brazil | Number Analyzed | 656 participants |
20 3.0%
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Canada | Number Analyzed | 656 participants |
60 9.1%
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France | Number Analyzed | 656 participants |
46 7.0%
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Germany | Number Analyzed | 656 participants |
17 2.6%
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Hungary | Number Analyzed | 656 participants |
34 5.2%
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Ireland | Number Analyzed | 656 participants |
38 5.8%
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Italy | Number Analyzed | 656 participants |
50 7.6%
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Japan | Number Analyzed | 656 participants |
29 4.4%
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Mexico | Number Analyzed | 656 participants |
39 5.9%
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Netherlands | Number Analyzed | 656 participants |
49 7.5%
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New Zealand | Number Analyzed | 656 participants |
43 6.6%
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Spain | Number Analyzed | 656 participants |
17 2.6%
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United Kingdom | Number Analyzed | 656 participants |
22 3.4%
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United States | Number Analyzed | 656 participants |
84 12.8%
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Venezuela | Number Analyzed | 656 participants |
34 5.2%
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Years of education
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 656 participants | |
14.58 (4.67) | ||
Marital status (married)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 656 participants | |
421 64.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Mark W Skinner |
Organization: | Institute for Policy Advancement Ltd |
Phone: | +1-202-253-8342 |
EMail: | mskinnerdc@gmail.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | McMaster University |
ClinicalTrials.gov Identifier: | NCT02439710 |
Other Study ID Numbers: |
HIREB-15-260D |
First Submitted: | April 28, 2015 |
First Posted: | May 12, 2015 |
Results First Submitted: | May 15, 2018 |
Results First Posted: | October 31, 2019 |
Last Update Posted: | October 31, 2019 |