Validation of Questionnaires HAL and HEP

NCT ID: NCT02512211

Last Updated: 2016-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Haemophilia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients adults

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

No interventions assigned to this group

Children with haemophilia

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

No interventions assigned to this group

Parents of children with haemophilia

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Rubén Cuesta-Barriuso, PhD

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RUBEN CUESTA-BARRIUSO, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio

Locations

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Universidad de Murcia

Murcia, Murcia, Spain

Site Status

Universidad Católica San Antonio, Murcia

Murcia, Murcia, Spain

Site Status

Countries

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Spain

Other Identifiers

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VALIDATION

Identifier Type: -

Identifier Source: secondary_id

VALIDATION

Identifier Type: -

Identifier Source: org_study_id

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