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CompletedNCT04109612SUN4PUpdated Apr 13, 2022

Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes-

An observational study in Cerebrovascular Disorders, sponsored by National and Kapodistrian University of Athens. Completed at 10 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by National and Kapodistrian University of Athens · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
913
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Cerebrovascular Disorders

Keywords

  • stroke
  • stroke care
  • stroke units
  • value of stroke care
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 913 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)
  • Patients with First ever acute stroke
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
913 participants (actual)
Target follow-up
3 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Mortality

    Patient based stroke (inpatient and outpatient) mortality

    Time frame: Through hospitalization completion, an average of 10 days

  2. Mortality

    Patient based stroke (inpatient and outpatient) mortality

    Time frame: One month

  3. Mortality

    Patient based stroke (inpatient and outpatient) mortality

    Time frame: Three months

  4. Modified Rankin Scale (mRS) score

    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)

    Time frame: Through hospitalization completion, an average of 10 days

  5. Modified Rankin Scale (mRS) score

    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)

    Time frame: One month

  6. Modified Rankin Scale (mRS) score

    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)

    Time frame: Three months

  7. National Institutes of Health Stroke Scale (NIHSS) score

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

    Time frame: Through hospitalization completion, an average of 10 days

  8. National Institutes of Health Stroke Scale (NIHSS) score

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

    Time frame: One month

  9. National Institutes of Health Stroke Scale (NIHSS) score

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

    Time frame: Three months

  10. Cost

    Average cost per patient

    Time frame: Through hospitalization completion, an average of 10 days

  11. Cost

    Average cost per patient

    Time frame: One month

  12. Cost

    Average cost per patient

    Time frame: Three months

07

Study locations

10 sites
  • National and Kapodistrian University of Athens
    Athens, 11527, Greece
  • Aiginiteio Hospital of Athens
    Athens, Greece
  • General Hospital of Athens Alexandra
    Athens, Greece
  • Hellenic Stroke Organization
    Athens, Greece
  • Laiko General Hospital of Athens
    Athens, Greece
  • Chania General Hospital St George
    Chania, Greece
  • University General Hospital of Ioannina
    Ioannina, Greece
  • General University Hospital of Larisa
    Larisa, Greece
  • University General Hospital of Thessaloniki Ahepa
    Thessaloniki, Greece
  • General Hospital of Tripoli Evaggelistria
    Tripoli, Greece
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04109612
Lead sponsor
National and Kapodistrian University of Athens
Collaborators
Hellenic Foundation for Research and Innovation, General Secretariat for Research and Technology, Hellenic Stroke Organization
Responsible party
OLGA SISKOU (Senior Researcher, National and Kapodistrian University of Athens) — Principal investigator
First posted
Sep 30, 2019
Start date
Jul 17, 2019
Primary completion
Oct 30, 2021
Completion
Jan 13, 2022
Last update
Apr 13, 2022

Study contacts

OLGA SISKOU, PhD
principal investigator · Senior Researcher on Health and Nursing Economics and Management
GEORGE NTAIOS, PhD
principal investigator · Head of Physicians /Nurses Team
GEORGE PAPASTEFANATOS, PhD
principal investigator · Head of IT Team

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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