Brief Title
Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia
Official Title
Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project
Brief Summary
Research project for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and reliability analysis with large sample of patients.
Detailed Description
The validated questionnaire obtained in this project will identify the actual degree of patient compliance to drug therapy, using as gold standard the difference between the treatment prescribed and administered.
Study Type
Observational
Primary Outcome
Translation of the original questionnaire (English) to Spanish
Condition
Haemophilia
Intervention
Patients with haemophilia
Study Arms / Comparison Groups
Patients with haemophilia
Description: Sample of patients with haemophilia over 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.
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
70
Start Date
September 2015
Completion Date
December 2015
Primary Completion Date
October 2015
Eligibility Criteria
Inclusion Criteria: - Patients with hemophilia A and B - Patients who have previously signed the informed consent document Exclusion Criteria: - Patients with other congenital coaghulopatías (eg, Von Willebrand's disease) - Patients with cognitive impairment, or oral or written understanding
Gender
Male
Ages
13 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Rubén Cuesta-Barriuso, PhD, +34 913146508, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02582450
Organization ID
Veritas-Validation
Responsible Party
Sponsor
Study Sponsor
Real Fundación Victoria Eugenia
Collaborators
Medtep Inc.
Study Sponsor
Rubén Cuesta-Barriuso, PhD, Principal Investigator, Real Fundación Victoria Eugenia
Verification Date
October 2015