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| Name | Class |
|---|---|
| Medtep Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with haemophilia | Other | Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with haemophilia around the country that will participate in study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Contact | +34 913146508 | ruben.cuestab@gmail.com | |
| Ana Torres-Ortuño, PhD | Contact | +34 868887170 | atorres.ortuno@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Real Fundación Victoria Eugenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Real Fundación Victoria Eugenia | Recruiting | Madrid | Madrid | 28029 | Spain |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 29, 2016 | |
| Reset | Aug 12, 2016 | |
| Release | Aug 26, 2016 | |
| Reset | Oct 18, 2016 | |
| Release | Dec 30, 2016 | |
| Reset | Feb 21, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2016 | Aug 12, 2016 | |||
| Aug 26, 2016 |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D055809 | Illness Behavior |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C005044 | hydroxyethyl methacrylate |
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| Oct 18, 2016 |
| Dec 30, 2016 | Feb 21, 2017 |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |