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Cerebrovascular DisordersSUN4PNCT04109612

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

An observational study of Cerebrovascular Disorders, run by National and Kapodistrian University of Athens at 10 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebrovascular Disorders
How many people
913 participants
Where
10 sitesGreece
Study dates
17 Jul 2019to 13 Jan 2022
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Greece10 sites

  • National and Kapodistrian University of Athens

    Athens, 11527

  • Aiginiteio Hospital of Athens

    Athens

  • General Hospital of Athens Alexandra

    Athens

  • Hellenic Stroke Organization

    Athens

  • Laiko General Hospital of Athens

    Athens

  • Chania General Hospital St George

    Chania

  • University General Hospital of Ioannina

    Ioannina

  • General University Hospital of Larisa

    Larissa

  • University General Hospital of Thessaloniki Ahepa

    Thessaloniki

  • General Hospital of Tripoli Evaggelistria

    Tripoli

Other trials in Greece

About this study

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

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.

Keywords
stroke, stroke care, stroke units, value of stroke care
Medical subject headings
Cerebrovascular Disorders, Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Patient based stroke (inpatient and outpatient) mortality

    Measured: Through hospitalization completion, an average of 10 days

  2. Mortality

    Patient based stroke (inpatient and outpatient) mortality

    Measured: One month

  3. Mortality

    Patient based stroke (inpatient and outpatient) mortality

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: Three months

  10. Cost

    Average cost per patient

    Measured: Through hospitalization completion, an average of 10 days

  11. Cost

    Average cost per patient

    Measured: One month

  12. Cost

    Average cost per patient

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2019
  2. Study start17 Jul 2019
  3. Primary completion30 Oct 2021
  4. Study completion13 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
913 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04109612
Sponsor's protocol ID
15117
Acronym
SUN4P
Status last verified
Apr 2022
First submitted
27 Sep 2019
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrovascular Disorders, run by National and Kapodistrian University of Athens at 10 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: Through hospitalization completion, an average of 10 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04109612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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