Validation of Questionnaires HAL and HEP

Universidad Católica San Antonio de Murcia60 enrolled

Overview

Spanish Validation of HAL and HEP questionnaire by double translation (English-Spanish-English), with a pilotage pediatric patients with hemophilia and adults and parents of children with hemophilia. The final validity will be obtained with a sample of 60-100 patients with hemophilia

Validation of the Spanish hemophilia specific questionnaires: HAL and HEP (adult version version version children and parents). To do this, there will be a double inverse translation, a pilotage of validity and clarity with a small sample of subjects and analysis of reliability and validity with more than 100 patients and parents of children with hemophilia to complete the validation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Haemophilia

Eligibility

Sex: ALLMin age: 8 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with hemophilia A and B * Parents of children with hemophilia A and B, under 18 * 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

Locations (2)

Universidad de Murcia

Murcia, Murcia, Spain

Universidad Católica San Antonio, Murcia

Murcia, Murcia, Spain

Outcomes

Primary Outcomes

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

Time frame: 1 day (Screening visit)

the translated version of the questionnaire

5 patients with hemophilia under 16, 5 patients with hemophilia adults , and 5 parents of children with hemophilia 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.

Time frame: 1 day (Screening visit)

Sending the questionnaire to a large sample of patients for final validation

40 hemophilia patients under 16 years old, 60 adult patients with hemophilia and 60 parents of children with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.

Time frame: 1 day (Screening visit)

Data from ClinicalTrials.gov

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