Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-02 @ 10:02 AM
Study NCT ID:
NCT00212459
Status:
COMPLETED
Last Update Posted:
2013-03-27
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study and control groups will be compared with respect to the % of bleeds reported to the HTC and % of recommended therapy recorded in bleeding logs after a 6 month period', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Study and control groups will be compared with respect to time between initiation of target joint bleeding and the identification and treatment of such by HTC personnel', 'timeFrame': '6 months'}, {'measure': 'Clotting factor consumption and the cost of therapy in each group will be compared', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bleeding logs', 'Factor Infusions'], 'conditions': ['Hemophilia A', 'Hemophilia B']}, 'descriptionModule': {'briefSummary': 'The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.', 'detailedDescription': 'The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.To do this subjects will be randomized into a control group and a group who will receive consistent counselling by a pharmacist about their bleeding logs.\n\nThe aims of the study are:\n\n* To provide a new method of bleeding and treatment documentation in the home setting (logs) to adolescent subjects with Hemophilia A or B\n* To counsel these subjects about adherence to their treatment regimen prescribed by physician and the importance of keeping accurate documentation of each bleeding episode and its treatment.\n* To improve maintenance of logs, to allow for 1) assessment of bleeding frequency and treatment efficacy and 2) early detection of target joint bleeding and the potential need for prophylactic factor replacement.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 12 through 20\n* Severe or moderate Hemophilia A or B\n* Self-infusing or transitioning to self infusion in the home setting\n* Already assigned responsibility of monitoring bleeding logs\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00212459', 'briefTitle': 'The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs', 'organization': {'class': 'OTHER', 'fullName': 'New York Presbyterian Hospital'}, 'officialTitle': 'A Prospective Randomized Pilot Study on the Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs', 'orgStudyIdInfo': {'id': 'Bleeding Logs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients are contacted every two weeks after initial counseling to discuss completion of bleeding records.', 'interventionNames': ['Behavioral: Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'After the initial counseling with regards to bleeding records, there are no more contacts made with the control patients.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Counseling', 'type': 'BEHAVIORAL', 'description': 'Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.', 'armGroupLabels': ['1']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'No more contacts are made with control patients after the initial counseling session.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Donna M DiMichele, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York Presbyterian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Donna DiMichele, MD', 'oldOrganization': 'New York Presbyterian Hospital'}}}}