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Patient Reported Outcomes Burdens and Experiences - Phase 2 (PROBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439710
Recruitment Status : Completed
First Posted : May 12, 2015
Results First Posted : October 31, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
National Hemophilia Foundation
Information provided by (Responsible Party):
McMaster University

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Hemophilia
Intervention Other: Quality of life measure (survey)
Enrollment 656
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
Hide Arm/Group Description

"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
Arm/Group Title Enrolled Population
Hide Arm/Group Description Patients with hemophilia A or hemophilia B with any degree of disease severity or controls
Overall Number of Baseline Participants 656
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 656 participants
41.9  (17.0)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 646 participants
Female
454
  70.3%
Male
192
  29.7%
[1]
Measure Analysis Population Description: Missing data
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Argentina Number Analyzed 656 participants
35
   5.3%
Australia Number Analyzed 656 participants
39
   5.9%
Brazil Number Analyzed 656 participants
20
   3.0%
Canada Number Analyzed 656 participants
60
   9.1%
France Number Analyzed 656 participants
46
   7.0%
Germany Number Analyzed 656 participants
17
   2.6%
Hungary Number Analyzed 656 participants
34
   5.2%
Ireland Number Analyzed 656 participants
38
   5.8%
Italy Number Analyzed 656 participants
50
   7.6%
Japan Number Analyzed 656 participants
29
   4.4%
Mexico Number Analyzed 656 participants
39
   5.9%
Netherlands Number Analyzed 656 participants
49
   7.5%
New Zealand Number Analyzed 656 participants
43
   6.6%
Spain Number Analyzed 656 participants
17
   2.6%
United Kingdom Number Analyzed 656 participants
22
   3.4%
United States Number Analyzed 656 participants
84
  12.8%
Venezuela Number Analyzed 656 participants
34
   5.2%
Years of education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 656 participants
14.58  (4.67)
Marital status (married)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 656 participants
421
  64.2%
1.Primary Outcome
Title Response Rate
Hide Description number of filled questionnaires compared to the total number that were sent out
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
patients with hemophilia (hemophilia A or B with any degree of disease severity) or controls
Arm/Group Title Enrolled Participants
Hide Arm/Group Description:

"Patients with hemophilia" (haemophilia A or B with any degree of disease severity) or

“Controls” (individuals with no bleeding disorders)

Overall Number of Participants Analyzed 656
Overall Number of Units Analyzed
Type of Units Analyzed: Questionnaires
1871
Count of Units
Unit of Measure: Questionnaires
656
  35.1%
2.Primary Outcome
Title Number of Participant Completing the Questionnaire Within 15 Minutes
Hide Description Number of participants completing the questionnaire within 15 minutes
Time Frame Up to 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enrolled Participants
Hide Arm/Group Description:

"Patients with hemophilia" (haemophilia A or B with any degree of disease severity) or

“Controls” (individuals with no bleeding disorders)

Overall Number of Participants Analyzed 656
Measure Type: Number
Unit of Measure: participants
474
3.Primary Outcome
Title Cost Per Completed Survey
Hide Description Human and financial resources used by local organization to run the survey - measured as median and full range
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enrolled Participants
Hide Arm/Group Description:

"Patients with hemophilia" (haemophilia A or B with any degree of disease severity) or

“Controls” (individuals with no bleeding disorders)

Overall Number of Participants Analyzed 656
Median (Full Range)
Unit of Measure: Dollars (USD) per participants
8.50
(1.20 to 64.30)
Time Frame 1 year
Adverse Event Reporting Description Although it is not anticipated that the PROBE Study Team would receive reports of adverse events within the scope of the Study, if the Investigators are made aware of an adverse event involving a product manufactured by a study sponsor , the Investigators commit to notify sponsor within one (1) business day of actually becoming aware of any significant product complaint, unexpected adverse event, or governmental investigation or inquiry involving a sponsor's product.
 
Arm/Group Title Enrolled Participants
Hide Arm/Group Description

"Patients with hemophilia" (haemophilia A or B with any degree of disease severity) or

“Controls” (individuals with no bleeding disorders)

All-Cause Mortality
Enrolled Participants
Affected / at Risk (%)
Total   0/656 (0.00%) 
Hide Serious Adverse Events
Enrolled Participants
Affected / at Risk (%)
Total   0/656 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled Participants
Affected / at Risk (%)
Total   0/656 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark W Skinner
Organization: Institute for Policy Advancement Ltd
Phone: +1-202-253-8342
EMail: mskinnerdc@gmail.com
Layout table for additonal information
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