Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT05315232
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2022-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Experiences of People Who Live With Glanzmanns Thrombasthenia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013915', 'term': 'Thrombasthenia'}], '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': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2022-03-15', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to understand the impact of GT on quality of life of affected individuals and their families.', 'timeFrame': 'one year', 'description': 'Incidence of reported impact of GT on daily life using validated questionnaires EQ5D, MIQ, PHQ9, Rosenbergs self esteem scale.'}], 'secondaryOutcomes': [{'measure': 'Identify levels of acceptability of current treatments and management approaches', 'timeFrame': 'one year', 'description': 'Rate of reported satisfaction with current treatments using self efficacy to manage disease assessment tool'}, {'measure': 'Identify areas of unmet need among people with GT', 'timeFrame': 'one year', 'description': 'Rate of reported unmet need using ED5D and MIQ'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glanzmann Thrombasthenia']}, 'descriptionModule': {'briefSummary': 'To understand the lived experiences of people with Glanzmanns Thrombasthenia', 'detailedDescription': 'A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey, qualitative in-depth interviews and bleed diary completion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns Thrombasthenia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of congenital (inherited) Glanzmanns Thrombasthenia\n\nExclusion Criteria:\n\nAcquired Glanzmanns Thrombasthenia'}, 'identificationModule': {'nctId': 'NCT05315232', 'briefTitle': 'The Experiences of People Who Live With Glanzmanns Thrombasthenia.', 'organization': {'class': 'OTHER', 'fullName': 'Haemnet'}, 'officialTitle': 'Glanzmanns 360. The Lived Experience of People With Glanzmanns.', 'orgStudyIdInfo': {'id': 'Glanzmanns 360'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Qualitative assessment', 'description': 'Survey (using validated quality of life assessment questionnaires) and one to one interviews of people and family members living with Glanzmanns Thrombasthenia', 'interventionNames': ['Other: survey and interview']}, {'label': 'Bleed diary', 'description': 'Daily bleed diary completion over 12 weeks', 'interventionNames': ['Other: survey and interview']}], 'interventions': [{'name': 'survey and interview', 'type': 'OTHER', 'otherNames': ['diary completion'], 'description': 'qualitative assessment', 'armGroupLabels': ['Bleed diary', 'Qualitative assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Mike Holland, BSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Haemnet'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF', 'CSR'], 'timeFrame': '3-6 months', 'ipdSharing': 'YES', 'description': 'The second part of the study will be conducted by Haemnet and Hemab - participant information will be shared after reconsenting'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haemnet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hemab ApS', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}