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Completed

NCT Number: NCT04109612

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

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

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Key information

Conditions

Cerebrovascular Disorders Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aiginiteio Hospital of Athens, Athens, Greece

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Mortality

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

    Patient based stroke (inpatient and outpatient) mortality

  2. Mortality

    Time frame: One month

    Patient based stroke (inpatient and outpatient) mortality

  3. Mortality

    Time frame: Three months

    Patient based stroke (inpatient and outpatient) mortality

  4. Modified Rankin Scale (mRS) score

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

    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)

  5. Modified Rankin Scale (mRS) score

    Time frame: One month

    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)

  6. 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)

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

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

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

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

    Time frame: One month

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

  9. 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)

  10. Cost

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

    Average cost per patient

  11. Cost

    Time frame: One month

    Average cost per patient

  12. Cost

    Time frame: Three months

    Average cost per patient

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • General Secretariat for Research and Technology
  • Hellenic Foundation for Research and Innovation
  • Hellenic Stroke Organization

Registry information

Official study title

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

Acronym: SUN4P

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 30, 2019
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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