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

• Conditions: Haemophilia
• Interventions: Other: Patients with haemophilia

• Registration Number: NCT02582450
• Lead Sponsor: Real Fundación Victoria Eugenia

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 Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with haemophilia	Patients with haemophilia	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.

Primary Outcome Measures

Name	Time	Method
Translation of the original questionnaire (English) to Spanish	1 day (Screening visit)	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.
The translated version of the questionnaire	1 day (Screening visit)	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.
Sending the questionnaire to a large sample of patients for final validation	1 day (Screening visit)	70 patients with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.

Trial Locations

Locations (1)

Real Fundación Victoria Eugenia; 🇪🇸 Madrid, Spain