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Colorado Adult Joint Assessment Scale (CAJAS) Validation

NCT ID: NCT02284789

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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CAJAS evaluation

Group Type OTHER

Colorado Adult Joint Assessment Evaluation

Intervention Type OTHER

Physical evaluation of 6 joints, ankles, knees and elbows

Interventions

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Colorado Adult Joint Assessment Evaluation

Physical evaluation of 6 joints, ankles, knees and elbows

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Orange, California, United States

Site Status

Aurora, Colorado, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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17819

Identifier Type: -

Identifier Source: org_study_id