Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02582450
Status:
UNKNOWN
Last Update Posted:
2015-10-21
First Post:
2015-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-08-12', 'releaseDate': '2016-06-29'}, {'resetDate': '2016-10-18', 'releaseDate': '2016-08-26'}, {'resetDate': '2017-02-21', 'releaseDate': '2016-12-30'}], 'estimatedResultsFirstSubmitDate': '2016-06-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D055809', 'term': 'Illness Behavior'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005044', 'term': 'hydroxyethyl methacrylate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2015-10-19', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Translation of the original questionnaire (English) to Spanish', 'timeFrame': '1 day (Screening visit)', 'description': '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.'}, {'measure': 'The translated version of the questionnaire', 'timeFrame': '1 day (Screening visit)', 'description': '10 patients with hemophilia adults enrolled randomly will participate in the pilotage.\n\nThe clarity of the questions in Spanish translated version and the relevance of each of the items of the questionnaires will be evaluated.'}, {'measure': 'Sending the questionnaire to a large sample of patients for final validation', 'timeFrame': '1 day (Screening visit)', 'description': '70 patients with hemophilia will participate in the pilotage. The validity and reliability of the Spanish version translated from the questionnaires will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haemophilia', 'Adherence of Treatment', 'Knowledge of Illness', 'Medical-patient Relationship', 'Illness Behavior', 'Treatment Difficulties', 'Veritas'], 'conditions': ['Haemophilia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with haemophilia around the country that will participate in study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with hemophilia A and B\n* Patients who have previously signed the informed consent document\n\nExclusion Criteria:\n\n* Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)\n* Patients with cognitive impairment, or oral or written understanding"}, 'identificationModule': {'nctId': 'NCT02582450', 'briefTitle': 'Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Real Fundación Victoria Eugenia'}, 'officialTitle': 'Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia. Veritas-Pro Project', 'orgStudyIdInfo': {'id': 'Veritas-Validation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with haemophilia', 'description': '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.', 'interventionNames': ['Other: Patients with haemophilia']}], 'interventions': [{'name': 'Patients with haemophilia', 'type': 'OTHER', 'description': 'Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.', 'armGroupLabels': ['Patients with haemophilia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28029', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'CONTACT', 'email': 'ruben.cuestab@gmail.com', 'phone': '+34 913146508'}], 'facility': 'Real Fundación Victoria Eugenia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'CONTACT', 'email': 'ruben.cuestab@gmail.com', 'phone': '+34 913146508'}, {'name': 'Ana Torres-Ortuño, PhD', 'role': 'CONTACT', 'email': 'atorres.ortuno@gmail.com', 'phone': '+34 868887170'}], 'overallOfficials': [{'name': 'Rubén Cuesta-Barriuso, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Real Fundación Victoria Eugenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Real Fundación Victoria Eugenia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtep Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-06-29', 'type': 'RELEASE'}, {'date': '2016-08-12', 'type': 'RESET'}, {'date': '2016-08-26', 'type': 'RELEASE'}, {'date': '2016-10-18', 'type': 'RESET'}, {'date': '2016-12-30', 'type': 'RELEASE'}, {'date': '2017-02-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Real Fundación Victoria Eugenia'}}}}