Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-26 @ 1:25 PM
Study NCT ID:
NCT05741593
Status:
RECRUITING
Last Update Posted:
2024-11-18
First Post:
2023-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of the verbatim from the transcription of the recorded interviews.', 'timeFrame': 'one year', 'description': 'Describing the content of discussions, relating to antithrombotic treatment for secondary prevention, between elderly patients previously treated with antithrombotics and admitted to hospital for an ischemic stroke and a pharmacist'}], 'secondaryOutcomes': [{'measure': "Analysis of verbatim statements from the transcription of recorded interviews on patients' representations and beliefs regarding antithrombotics", 'timeFrame': '15 to 60 minutes per patient', 'description': "Exploring patients' representations and beliefs regarding antithrombotics before and after the onset of stroke or recurrence of stroke"}, {'measure': "Analysis of verbatim statements from the transcription of recorded interviews on patients' medication adherence to antithrombotics", 'timeFrame': '15 to 60 minutes per patient', 'description': "Explore patients' medication adherence to antithrombotics before the onset of stroke or recurrence of stroke"}, {'measure': 'Analysis of verbatim statements from the transcription of recorded interviews on the impact of the occurrence of stroke or recurrence of stroke on medication adherence', 'timeFrame': '15 to 60 minutes per patient', 'description': 'Explore the impact of stroke occurrence or stroke recurrence on patient medication adherence (including motivation, ambivalence, confidence in medication benefits)'}, {'measure': 'Analysis of verbatim statements from the transcription of recorded interviews on the obstacles and levers to medication adherence', 'timeFrame': '15 to 60 minutes per patient', 'description': 'Identify the barriers and levers to drug adherence with antithrombotics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Qualitative study', 'semi-structured interview', 'antithrombotic', 'stroke', 'medication adherence'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. There are brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.', 'detailedDescription': 'Cerebrovascular accident is the 2nd leading cause of death and the leading cause of disability in the world. The probability of stroke recurrence is high: about 25% the first year , and 30 to 40% in the 5 years following the stroke. Recurrent strokes are responsible for significant disability, institutionalization, major neurocognitive disorders, and death.\n\nIn order to reduce the risk of stroke recurrence, multiple secondary prevention strategies have demonstrated their effectiveness, such as the prescription of drugs (in particular statins and antithrombotics), the establishment of a balanced diet, the practice of an activity physical, or even tobacco addiction.\n\nHowever, the effectiveness of these strategies is optimal if and only if patients adhere to them.\n\nIn addition, previous studies have focused on the brakes and levers of medication adherence in the context of secondary prevention treatment in stroke.\n\nIn elderly patients, other obstacles could have been identified by specific studies, such as cognitive, sensory, functional disorders or even isolation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 65 and over, hospitalized for an ischemic stroke or a recurrence of ischemic stroke, being already treated with an antithrombotic treatment hospitalized at the Charpennes hospital with a plan to return home', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 65 and over\n* Patients hospitalized for an ischemic stroke or a recurrence of ischemic stroke, already being treated with an antithrombotic treatment (antiplatelet agent or anticoagulant ) prior to the stroke\n* Patients living at home and with a plan to return home.\n* Patients who did not object to the study and who gave their consent for the recording of the interview\n\nExclusion Criteria:\n\n* Patients with cognitive disorders or stroke sequelae that do not allow a semi-directive interview to be carried out (at medical discretion).\n* Non-French speaking patients'}, 'identificationModule': {'nctId': 'NCT05741593', 'acronym': 'QUATRO', 'briefTitle': 'Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Qualitative Analysis of Interviews Between Pharmacist and Elderly Patients Treated with Antithrombotics for an Ischemic Stroke.', 'orgStudyIdInfo': {'id': '69HCL22_1074'}, 'secondaryIdInfos': [{'id': '2023-A00181-44', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients having had a stroke', 'description': 'elderly patients previously treated with an antithrombotic and admitted to hospital for an ischemic stroke', 'interventionNames': ['Other: Analysis of the verbatim from the transcription of the recorded interviews.']}], 'interventions': [{'name': 'Analysis of the verbatim from the transcription of the recorded interviews.', 'type': 'OTHER', 'description': 'recorded semi-structured interviews between the patients and the pharmacist', 'armGroupLabels': ['Patients having had a stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69100', 'city': 'Villeurbanne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Teddy NOVAIS, PharmD, PhD', 'role': 'CONTACT'}], 'facility': 'institute of aging - Hôpital des Charpennes', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'centralContacts': [{'name': 'Teddy Novais, PharmD, PhD', 'role': 'CONTACT', 'email': 'teddy.novais@chu-lyon.fr', 'phone': '+33472432155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}