Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia

NCT ID: NCT02582450

Last Updated: 2015-10-21

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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The validated questionnaire obtained in this project will identify the actual degree of patient compliance to drug therapy, using as gold standard the difference between the treatment prescribed and administered.

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 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.

Patients with haemophilia

Intervention Type OTHER

Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.

Interventions

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Patients with haemophilia

Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with hemophilia A and B
* 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

13 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medtep Inc.

INDUSTRY

Sponsor Role collaborator

Real Fundación Victoria Eugenia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Real Fundación Victoria Eugenia

Locations

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Real Fundación Victoria Eugenia

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rubén Cuesta-Barriuso, PhD

Role: CONTACT

+34 913146508

Ana Torres-Ortuño, PhD

Role: CONTACT

+34 868887170

Facility Contacts

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Rubén Cuesta-Barriuso, PhD

Role: primary

+34 913146508

Other Identifiers

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Veritas-Validation

Identifier Type: -

Identifier Source: org_study_id

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