Haemophilia Clinical Trial
— VALIDATIONOfficial title:
Spanish Validation of "Haemophilia Activities List" (HAL) and "Specific Sport Scale" (HEP-Test-Q) Questionnaires
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 |
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
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 coaghulopatÃas (eg, Von Willebrand's disease) - Patients with cognitive impairment, or oral or written understanding |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Católica San Antonio, Murcia | Murcia | |
Spain | Universidad de Murcia | Murcia |
Lead Sponsor | Collaborator |
---|---|
Universidad Católica San Antonio de Murcia |
Spain,
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 |
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