Validation of Questionnaires HAL and HEP (VALIDATION)

June 30, 2016 updated by: Rubén Cuesta-Barriuso, PhD, Universidad Católica San Antonio de Murcia

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

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30100
        • Universidad de Murcia
      • Murcia, Spain, 30107
        • Universidad Católica San Antonio, Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia and parents of children with hemophilia around the country that will participate in study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Translation of the original questionnaire (English) to Spanish
Time Frame: 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
1 day (Screening visit)
the translated version of the questionnaire
Time Frame: 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.
1 day (Screening visit)
Sending the questionnaire to a large sample of patients for final validation
Time Frame: 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.
1 day (Screening visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALIDATION

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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