Overview

This trial is active, not recruiting.

Condition haemophilia
Sponsor Universidad Católica San Antonio de Murcia
Start date October 2015
End date May 2016
Trial size 60 participants
Trial identifier NCT02512211, VALIDATION

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
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
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

Primary Outcomes

Measure
Translation of the original questionnaire (English) to Spanish
time frame: 1 day (Screening visit)
the translated version of the questionnaire
time frame: 1 day (Screening visit)
Sending the questionnaire to a large sample of patients for final validation
time frame: 1 day (Screening visit)

Eligibility Criteria

Male or female participants from 8 years up to 65 years old.

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

Additional Information

Official title Spanish Validation of "Haemophilia Activities List" (HAL) and "Specific Sport Scale" (HEP-Test-Q) Questionnaires
Principal investigator RUBEN CUESTA-BARRIUSO, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Universidad Católica San Antonio de Murcia.