Validation of Questionnaires HAL and HEP

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Spanish Validation of Haemophilia Activities List (HAL) and Specific Sport Scale (HEP-Test-Q) Questionnaires

Conditions
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Haemophilia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients adults<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 HAL and HEP questionnaires | |
| Children with haemophilia<br>Sign hemophilia patients under 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the HAL and HEP questionnaires | |
| Parents of children with haemophilia<br>Sample of parents of children with hemophilia under 18 years of age that will participate in piloting of reliability and validity of the Spanish version of the HAL and HEP questionnaires | |

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 | 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. | 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. | 1 day (Screening visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemophilia, Validation, Questionnaires, Activities, Sport, Patients