Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia

Haemophilia Clinical Trial

Official title:

Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02582450
• Other study ID #: Veritas-Validation
• Status: Unknown status
• Phase: N/A
• First received: October 19, 2015
• Last updated: October 19, 2015
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Real Fundación Victoria Eugenia
• Contact: Rubén Cuesta-Barriuso, PhD
• Phone: +34 913146508
• Email: ruben.cuestab[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Intervention

Other:
• Patients with haemophilia
Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.

Locations

Country	Name	City	State
Spain	Real Fundación Victoria Eugenia	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Real Fundación Victoria Eugenia	Medtep Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Translation of the original questionnaire (English) to Spanish	Three health experienced in the treatment of hemophilia and knowledge of English, translated into Spanish the HAL and HEP questionnaire. Two native speakers (English and Spanish), reverse-translate the original text of the HAL and HEP questionnaires and the text translated by the Spanish health.	1 day (Screening visit)
Primary	The translated version of the questionnaire	10 patients with hemophilia adults enrolled randomly will participate in the pilotage.; The clarity of the questions in Spanish translated version and the relevance of each of the items of the questionnaires will be evaluated.	1 day (Screening visit)
Primary	Sending the questionnaire to a large sample of patients for final validation	70 patients with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.	1 day (Screening visit)