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Clinical Trials/NCT04109612
NCT04109612
Completed
Not Applicable

Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes- Stroke Units Necessity for Patients (SUN4P)

National and Kapodistrian University of Athens10 sites in 1 country913 target enrollmentJuly 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Disorders
Sponsor
National and Kapodistrian University of Athens
Enrollment
913
Locations
10
Primary Endpoint
Modified Rankin Scale (mRS) score
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The main objectives of the proposed project are:

  1. To provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement
  2. 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.
  3. To evaluate patients' and physicians' experiences and their impact on stroke management.
  4. To assess severe negative impact of stroke on the life of survivors including quality of life and disability
  5. To measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach
  6. To evaluate the value of care focusing on health outcomes compared with total costs of achieving them

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 17, 2019
End Date
January 13, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

OLGA SISKOU

Senior Researcher

National and Kapodistrian University of Athens

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)
  • Patients with First ever acute stroke

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Modified Rankin Scale (mRS) score

Time Frame: Three months

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)

National Institutes of Health Stroke Scale (NIHSS) score

Time Frame: Three months

NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)

Mortality

Time Frame: Three months

Patient based stroke (inpatient and outpatient) mortality

Cost

Time Frame: Three months

Average cost per patient

Study Sites (10)

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