Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02241694
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2014-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], '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': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2014-09-01', 'studyFirstSubmitQcDate': '2014-09-12', 'lastUpdatePostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative assessments of perceived impact on daily life', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Perceived disease control', 'timeFrame': 'Day 1'}, {'measure': 'Carrier status and reactions to haemophilia diagnosis', 'timeFrame': 'Day 1'}, {'measure': 'Genetic counselling and testing', 'timeFrame': 'Day 1'}, {'measure': 'Impact of haemophilia in siblings', 'timeFrame': 'Day 1'}, {'measure': 'Satisfaction with support from partners, family, friends, others', 'timeFrame': 'Day 1'}, {'measure': 'Sexual intimacy with partners in long-term relationships', 'timeFrame': 'Day 1'}, {'measure': 'Treatment method, compliance and location', 'timeFrame': 'Day 1'}, {'measure': 'Modified WHO-5 (World Health Organization-Five Well Being Index)', 'timeFrame': 'Day 1'}, {'measure': 'Knowledge and information about haemophilia', 'timeFrame': 'Day 1'}, {'measure': 'Improvements in haemophilia care', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Haemophilia A', 'Haemophilia B', 'Haemophilia A With Inhibitors', 'Haemophilia B With Inhibitors', 'Relatives to/Carers of Patients']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult males with haemophilia and parents/carers of children with haemophilia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or B (with or without inhibitors); only one subject per household will be able to participate\n* Patients currently receiving one of the following treatments: a. replacement factor VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous haemorrhage into one or more joints within the last 12 months\n* The participants (patients with haemophilia and parents/caregivers for patients under 18 years old) must be able to complete a paper questionnaire in order to participate in the study\n* Providing informed consent before the start of any study-related activities\n\nExclusion Criteria:\n\n* Inability for the patients or parents/caregivers to understand and comply with verbal instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or by a relative. (No other conditions were established for patients who cannot read or write to be able to participate in this study in addition to the need of help from a member of HTC or by a relative.)'}, 'identificationModule': {'nctId': 'NCT02241694', 'acronym': 'HERO', 'briefTitle': 'To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Haemophilia, Experiences, Results and Opportunities (HERO) in Brazil: Assessment of Psychological Effects of Haemophilia on Patients and Caregivers', 'orgStudyIdInfo': {'id': 'F7HAEM-4146'}, 'secondaryIdInfos': [{'id': 'U1111-1147-4202', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'survey', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'No treatment given. Participants are to complete a questionnaire in the study.', 'armGroupLabels': ['survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05001-400', 'city': 'Säo Paulo', 'country': 'Brazil'}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452), GZZF', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}