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Administrative data

NCT number NCT02582450
Other study ID # Veritas-Validation
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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