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

October 19, 2015 updated by: Real Fundación Victoria Eugenia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

70

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
      • Madrid, Spain, 28029
        • Recruiting
        • Real Fundación Victoria Eugenia

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia around the country that will participate in study.

Description

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

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
Intervention / Treatment
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.
Other: Patients with haemophilia
Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.

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)

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
Time Frame: 1 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.
1 day (Screening visit)

Collaborators and Investigators

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

Sponsor

Real Fundación Victoria Eugenia

Collaborators

Medtep Inc.

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

September 1, 2015

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (ESTIMATE)

October 21, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 19, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Veritas-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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