Validation of Questionnaires HAL and HEP

Haemophilia Clinical Trial

— VALIDATION  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02512211
• Other study ID #: VALIDATION
• Secondary ID: VALIDATION
• Status: Active, not recruiting
• Phase: N/A
• First received: July 22, 2014
• Last updated: June 30, 2016
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: June 2016
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Haemophilia

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio, Murcia	Murcia
Spain	Universidad de Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

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)	No
Primary	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)	No
Primary	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)	No