NCT02512211

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

7 months

First QC Date

July 22, 2014

Last Update Submit

June 30, 2016

Conditions

Haemophilia

Keywords

HemophiliaValidationQuestionnairesActivitiesSportPatients

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (3)

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

Eligibility Criteria

Age8 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
  • Patients with cognitive impairment, or oral or written understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidad de Murcia

Murcia, Murcia, 30100, Spain

Location

Universidad Católica San Antonio, Murcia

Murcia, Murcia, 30107, Spain

Location

MeSH Terms

Conditions

Hemophilia AMotor Activity

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Study Officials

  • RUBEN CUESTA-BARRIUSO, PhD

    Universidad Católica San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 30, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

ES(2)