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

Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02582450
Enrollment
70
Registered
2015-10-21
Start date
2015-09-30
Completion date
2015-12-31
Last updated
2015-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia

Keywords

Haemophilia, Adherence of Treatment, Knowledge of Illness, Medical-patient Relationship, Illness Behavior, Treatment Difficulties, Veritas

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.

Detailed description

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.

Interventions

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

Sponsors

Medtep Inc.
CollaboratorINDUSTRY
Real Fundación Victoria Eugenia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
13 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Translation of the original questionnaire (English) to Spanish1 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.
The translated version of the questionnaire1 day (Screening visit)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.
Sending the questionnaire to a large sample of patients for final validation1 day (Screening visit)70 patients with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.

Countries

Spain

Contacts

Primary ContactRubén Cuesta-Barriuso, PhD
ruben.cuestab@gmail.com+34 913146508
Backup ContactAna Torres-Ortuño, PhD
atorres.ortuno@gmail.com+34 868887170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026