Colorado Adult Joint Assessment Scale (CAJAS) Validation (CAJAS)

December 2, 2015 updated by: Bayer

Content and Psychometric Validation Study of the Colorado Adult Joint Assessment Scale (CAJAS) in Subjects With Moderate to Severe Hemophilia A Treated on Prophylaxis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Oregon
      • Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CAJAS evaluation
Other: Colorado Adult Joint Assessment Evaluation
Physical evaluation of 6 joints, ankles, knees and elbows

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Colorado Adult Joint Assessment Score (CAJAS)
Time Frame: Up to 25 days
Up to 25 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17819

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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