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:
National and Kapodistrian University of Athens
Organization:
Study Overview
Official Title:
Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes- Stroke Units Necessity for Patients (SUN4P)
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUN4P
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
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: