Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-04-02 @ 1:31 AM
Study NCT ID:
NCT04109612
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2019-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 913}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Through hospitalization completion, an average of 10 days', 'description': 'Patient based stroke (inpatient and outpatient) mortality'}, {'measure': 'Mortality', 'timeFrame': 'One month', 'description': 'Patient based stroke (inpatient and outpatient) mortality'}, {'measure': 'Mortality', 'timeFrame': 'Three months', 'description': 'Patient based stroke (inpatient and outpatient) mortality'}, {'measure': 'Modified Rankin Scale (mRS) score', 'timeFrame': 'Through hospitalization completion, an average of 10 days', 'description': 'mRS measures the degree of disability or dependence in the daily activities of patients after a stroke or other causes of neurological disability (0: no symptoms at all - 6: Dead)'}, {'measure': 'Modified Rankin Scale (mRS) score', 'timeFrame': 'One month', 'description': 'mRS measures the degree of disability or dependence in the daily activities of patients after a stroke or other causes of neurological disability (0: no symptoms at all - 6: Dead)'}, {'measure': 'Modified Rankin Scale (mRS) score', 'timeFrame': 'Three months', 'description': 'mRS measures the degree of disability or dependence in the daily activities of patients after a stroke or other causes of neurological disability (0: no symptoms at all - 6: Dead)'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) score', 'timeFrame': 'Through hospitalization completion, an average of 10 days', 'description': 'NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42:Severe Stroke)'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) score', 'timeFrame': 'One month', 'description': 'NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)'}, {'measure': 'National Institutes of Health Stroke Scale (NIHSS) score', 'timeFrame': 'Three months', 'description': 'NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)'}, {'measure': 'Cost', 'timeFrame': 'Through hospitalization completion, an average of 10 days', 'description': 'Average cost per patient'}, {'measure': 'Cost', 'timeFrame': 'One month', 'description': 'Average cost per patient'}, {'measure': 'Cost', 'timeFrame': 'Three months', 'description': 'Average cost per patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'stroke care', 'stroke units', 'value of stroke care'], 'conditions': ['Cerebrovascular Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sun4patients.gr/en', 'label': 'Project site'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32604692', 'label': "Paper entitled:Access of Stroke Patients' to Optimal Healthcare Technology in Greece: Messages to Policy Makers"}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32604697', 'label': "Paper entitled: Developing Patients' Experiences Database After Hospital Discharge: Another Step In Improving Stroke Care"}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32604689/', 'label': 'Paper entitled: Sun4Patients Web Platform: Facilitating Long-Term Monitoring of Stroke Patients'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35062158/', 'label': 'Paper entitled: Stroke Units Necessity for Patients, Web-Based "SUN4P" Registry: Descriptive Characteristics of the Population'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35062174/', 'label': 'Paper entitled:Assessing Staff\'s and Stroke Patients\' Experiences in 8 Hospitals in Greece: Results from a Prospective Multi-Center Study ("SUN4Patients")'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35062185/', 'label': 'Paper entitled: Inpatient Cost of Stroke Care in Greece: Preliminary Results of the Web-Based "SUN4P" Registry'}]}, 'descriptionModule': {'briefSummary': "The main objectives of the proposed project are:\n\n1. To provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement\n2. To develop an interactive multichannel platform, for collecting, cleansing and curating high quality in-hospital and follow up data, applying multidimensional quality assessment analysis, providing statistical and analytic reports, monitoring behavioral changes and supporting overall project's management.\n3. To evaluate patients' and physicians' experiences and their impact on stroke management.\n4. To assess severe negative impact of stroke on the life of survivors including quality of life and disability\n5. To measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach\n6. To evaluate the value of care focusing on health outcomes compared with total costs of achieving them", 'detailedDescription': 'A prospective cohort multicenter study of patients with first ever acute stroke, hemorrhagic and ischemic, (ICD-10 codes: I61, I63 and I64) admitted within 48 hours of symptoms onset to seven NHS and University hospitals will be conducted. About 1,000 patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of Greek population), reporting 25,000 discharged stroke cases annually (53% of all stroke discharges), according to data derived from Hellenic Statistical Authority. All patients will be followed for three months. Moreover, a sub-group of the 300 firstly recruited patients will be followed for a year to obtain data on post hospital health and social needs, health services utilization (medication, rehabilitation, outpatient visits) and productivity loss . Patient enrolment and follow up is estimated to last 18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'About 1,000 first ever stroke patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of Greek population), reporting 25,000 discharged stroke cases annually. All patients will be followed for three months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)\n* Patients with First ever acute stroke'}, 'identificationModule': {'nctId': 'NCT04109612', 'acronym': 'SUN4P', 'briefTitle': 'Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes- Stroke Units Necessity for Patients (SUN4P)', 'orgStudyIdInfo': {'id': '15117'}}, 'contactsLocationsModule': {'locations': [{'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'National and Kapodistrian University of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Aiginiteio Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens Alexandra', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Hellenic Stroke Organization', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Laiko General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Chania', 'country': 'Greece', 'facility': 'Chania General Hospital St George', 'geoPoint': {'lat': 35.51124, 'lon': 24.02921}}, {'city': 'Ioannina', 'country': 'Greece', 'facility': 'University General Hospital of Ioannina', 'geoPoint': {'lat': 39.66341, 'lon': 20.85187}}, {'city': 'Larissa', 'country': 'Greece', 'facility': 'General University Hospital of Larisa', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'University General Hospital of Thessaloniki Ahepa', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Tripoli', 'country': 'Greece', 'facility': 'General Hospital of Tripoli Evaggelistria', 'geoPoint': {'lat': 37.50959, 'lon': 22.37883}}], 'overallOfficials': [{'name': 'OLGA SISKOU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Senior Researcher on Health and Nursing Economics and Management'}, {'name': 'GEORGE NTAIOS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Physicians /Nurses Team'}, {'name': 'GEORGE PAPASTEFANATOS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of IT Team'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hellenic Foundation for Research and Innovation', 'class': 'UNKNOWN'}, {'name': 'General Secretariat for Research and Technology', 'class': 'UNKNOWN'}, {'name': 'Hellenic Stroke Organization', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'OLGA SISKOU', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}