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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Haemophilia

Intervention / Treatment
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* Other: Patients with haemophilia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with haemophilia<br>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. | Other: Patients with haemophilia<br>* Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemophilia, Adherence of Treatment, Knowledge of Illness, Medical-patient Relationship, Illness Behavior, Treatment Difficulties, Veritas