Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia
1 other identifier
observational
70
1 country
1
Brief Summary
Research project for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and reliability analysis with large sample of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 21, 2015
October 1, 2015
1 month
October 19, 2015
October 19, 2015
Conditions
Keywords
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
10 patients with hemophilia adults 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
70 patients 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 (1)
Patients with haemophilia
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 Veritas-Pro questionnaire.
Interventions
Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.
Eligibility Criteria
Patients with haemophilia around the country that will participate in study.
You may qualify if:
- Patients with hemophilia A and B
- 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
- Real Fundación Victoria Eugenialead
- Medtep Inc.collaborator
Study Sites (1)
Real Fundación Victoria Eugenia
Madrid, Madrid, 28029, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubén Cuesta-Barriuso, PhD
Real Fundación Victoria Eugenia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 21, 2015
Study Start
September 1, 2015
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
October 21, 2015
Record last verified: 2015-10