Validation of Questionnaires HAL and HEP

• Conditions: Haemophilia

• Registration Number: NCT02512211
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Study Start: 2015-10
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-01
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Translation of the original questionnaire (English) to Spanish	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
Sending the questionnaire to a large sample of patients for final validation	1 day (Screening visit)	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.
the translated version of the questionnaire	1 day (Screening visit)	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.

Trial Locations

Locations (2)

Universidad de Murcia; 🇪🇸 Murcia, Spain

Universidad Católica San Antonio, Murcia; 🇪🇸 Murcia, Spain