Validation of Questionnaires HAL and HEP

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02512211

Acronym

VALIDATION

Enrollment

Registered

2015-07-30

Start date

2015-10-31

Completion date

2016-10-31

Last updated

2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia

Keywords

Hemophilia, Validation, Questionnaires, Activities, Sport, Patients

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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.

Countries

Spain

Outcome results