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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary: 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.
Sponsor: Real Fundación Victoria Eugenia

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Real Fundación Victoria Eugenia

Dates:
Date Received: October 19, 2015
Date Started: September 2015
Date Completion: December 2015
Last Updated: October 19, 2015
Last Verified: October 2015