Brief Title
Colorado Adult Joint Assessment Scale (CAJAS) Validation
Official Title
Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis
Brief Summary
To obtain evidence of content validity and reliability of the Colorado Adult Joint Assessment Scale (CAJAS), a clinician-reported outcome (ClinRO) measure, as adapted for use in a population of adults with moderate to severe hemophilia A treated with coagulation factor VIII (FVIII) therapy as secondary prophylaxis or episodic treatment.
Study Type
Interventional
Primary Outcome
Colorado Adult Joint Assessment Score (CAJAS)
Condition
Hemophilia A
Intervention
Colorado Adult Joint Assessment Evaluation
Study Arms / Comparison Groups
CAJAS evaluation
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
30
Start Date
February 2015
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility Criteria
Inclusion Criteria: - Male, 18 to 50 years of age - Diagnosis of moderate to severe hemophilia A (documented <1-2% Factor VIII Concentration [FVIII:C]) - Willing to maintain current FVIII treatment regimen, whether prophylactic or on-demand, for the duration of the study Exclusion Criteria: - Routine need for wheelchair or routine need for two canes or crutches - Diagnosis of another bleeding disorder such as von Willebrand Disease - Known event that would interfere with the scheduled CAJAS evaluations (e.g., elective joint surgery, vacation)
Gender
Male
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02284789
Organization ID
17819
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
December 2015