Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT02581735
Status:
UNKNOWN
Last Update Posted:
2016-06-30
First Post:
2015-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-07-12', 'releaseDate': '2017-09-26'}, {'resetDate': '2019-05-31', 'releaseDate': '2019-02-19'}], 'estimatedResultsFirstSubmitDate': '2017-09-26'}}, '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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-10-19', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Registration of the uPatient platform', 'timeFrame': 'Screening visit', 'description': 'This register indicates the number of infusions'}, {'measure': 'Change from baseline the quality of life at 6 months and at the end of the study', 'timeFrame': 'Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year', 'description': 'Quality of life questionnaire (SF-36)'}, {'measure': 'Change from baseline the perception of disease at 6 months and at the end of the study', 'timeFrame': 'Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year', 'description': 'Questionnaire to evaluate the perception of disease (Questionnaire IPQ-R)'}, {'measure': 'Change from baseline the compliance to the prophylactic treatment at 6 months and at the end of the study', 'timeFrame': 'Screening visit, up to 4 weeks, up to 24 weeks and through study completion, an average of 1 year', 'description': 'Spanish version of the questionnaire for compliance to prophylactic treatment in patients with haemophilia (Veritas-Pro).'}, {'measure': 'Change from baseline the joint status at the end of the study', 'timeFrame': 'Screening visit and through study completion, an average of 1 year', 'description': 'Spanish version of the Haemophilia Joint Health Score (HJHS), to assess the joint status in patients with hemophilia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Haemophilia', 'Adherence', 'Prophylaxis treatment', 'Quality of Life', 'Illness Behavior', 'Veritas-Pro questionnaire', 'uPatient'], 'conditions': ['Haemophilia']}, 'descriptionModule': {'briefSummary': 'Research project whose main objective is to evaluate the use of a technology platform (uPatient) to register the prophylactic treatment of patients with hemophilia treated in different Hematology and Hemotherapy services of several hospitals in Spain.', 'detailedDescription': 'The data obtained in this project will identify the level of compliance to the pharmacological treatment of patients with hemophilia prophylaxis. They will use different psychosocial questionnaires based on scientific evidence and the reliability of these, as well as its specific design for patients with hemophilia. Clinical data were also obtained regarding the joint of patients participating in the study state.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with haemophilia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with hemophilia A or B\n* Patients over 13 years old\n* Patients on prophylactic treatment.\n\nExclusion Criteria:\n\n* Patients who do not sign the informed consent document\n* Patients who do not make domiciliary self-treatment\n* Patients who do not have good adhesion to prophylactic treatment'}, 'identificationModule': {'nctId': 'NCT02581735', 'acronym': 'uPatient', 'briefTitle': 'Effectiveness of the uPatient Platform in Prophylactic Treatment in Hemophilia', 'organization': {'class': 'OTHER', 'fullName': 'Real Fundación Victoria Eugenia'}, 'officialTitle': 'Effectiveness of the uPatient Platform in the Fulfillment of the Prophylactic Treatment in Patients With Hemophilia', 'orgStudyIdInfo': {'id': 'uPatient'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with haemophilia', 'description': 'Using the platform Upatient, patients with hemophilia will register for one year, the prophylactic treatment who receive at home. Likewise, they indicate a replacement therapy as a result of joint bleeds.\n\nAt baseline, a month, 6 months and at the end of the study, patients shall complete two questionnaires. The same way in the initial evaluation and end of the study, the clinical joint status will be evaluated with HJHS scale .', 'interventionNames': ['Other: Patients with haemophilia']}], 'interventions': [{'name': 'Patients with haemophilia', 'type': 'OTHER', 'description': 'Using the platform Upatient, patients with hemophilia will register for one year, the prophylactic treatment who receive at home. Likewise, they indicate a replacement therapy as a result of joint bleeds.\n\nAt baseline, a month, 6 months and at the end of the study, patients shall complete two questionnaires. The same way in the initial evaluation and end of the study, the clinical joint status will be evaluated with HJHS scale .', 'armGroupLabels': ['Patients with haemophilia']}]}, 'contactsLocationsModule': {'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': 'Universidad de Murcia', 'class': 'OTHER'}, {'name': 'Medtep Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-26', 'type': 'RELEASE'}, {'date': '2018-07-12', 'type': 'RESET'}, {'date': '2019-02-19', 'type': 'RELEASE'}, {'date': '2019-05-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Real Fundación Victoria Eugenia'}}}}