Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Haemophilia
- Sponsor
- Real Fundación Victoria Eugenia
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Translation of the original questionnaire (English) to Spanish
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Translation of the original questionnaire (English) to Spanish
Time Frame: 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
Time Frame: 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
Time Frame: 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.