Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-04-21 @ 1:03 PM
Study NCT ID:
NCT02647957
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2015-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy of the Code Stroke in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2015-12-26', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery rate of the Intravenous trombolysis treatment', 'timeFrame': '1 month', 'description': 'Number of patients showing an adequate recovery after Intravenous trombolysis treatment as assessed by the criteria of the Quality Indicator Board of the German Stroke Registers Study Group and the National Sentinel Audit of Stroke.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '1 month', 'description': 'Patient Satisfaction Scale'}, {'measure': 'Patient engage', 'timeFrame': '1 month', 'description': 'Health literacy Scale'}, {'measure': 'response capacity', 'timeFrame': '1 day', 'description': 'Response time for the initial evaluation and treatment'}, {'measure': 'Treatment adequacy: Intravenous trombolysis treatment', 'timeFrame': '1 month', 'description': 'Intravenous trombolysis treatment applied in eligible ischemic stroke patients'}, {'measure': 'Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis', 'timeFrame': '1 month', 'description': 'Recombinant tissue plasminogen activator complication rates'}, {'measure': 'Mortality rates of the Intravenous trombolysis treatment', 'timeFrame': '1 month', 'description': 'Mortality rates of the Intravenous trombolysis treatment when applied in eligible ischemic stroke patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute ischemic stroke', 'quality'], 'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '10604170', 'type': 'RESULT', 'citation': 'Alvarez Sabin J, Molina C, Abilleira S, Montaner J, Garcia F, Alijotas J. ["Stroke code". Shortening the delay in reperfusion treatment of acute ischemic stroke]. Med Clin (Barc). 1999 Oct 23;113(13):481-3. Spanish.'}]}, 'descriptionModule': {'briefSummary': 'Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).', 'detailedDescription': 'In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent.\n\nA Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute ischemic stroke in-patients\n\nExclusion Criteria:\n\n* Patients who refuse participate'}, 'identificationModule': {'nctId': 'NCT02647957', 'acronym': 'QICS', 'briefTitle': 'A Study of the Efficacy of the Code Stroke in Spain', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain', 'orgStudyIdInfo': {'id': '489/2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Hospital using Code Stroke', 'interventionNames': ['Procedure: Code Stroke']}, {'type': 'NO_INTERVENTION', 'label': 'Group B', 'description': 'Hospital not using Code Stroke'}], 'interventions': [{'name': 'Code Stroke', 'type': 'PROCEDURE', 'description': 'Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.', 'armGroupLabels': ['Group A']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, {'name': 'Hospital Serranía de Ronda', 'class': 'UNKNOWN'}, {'name': 'Hospital of Navarra', 'class': 'OTHER'}, {'name': 'Hospital Virgen de la Concha', 'class': 'UNKNOWN'}, {'name': 'Hospital of Jaen', 'class': 'OTHER'}, {'name': 'Hospital General San Jorge', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'José Joaquín Mira', 'investigatorAffiliation': 'Universidad Miguel Hernandez de Elche'}}}}