Improved Stroke Outcome at 6 Months
| Tracking Information | |||||
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| First Received Date ICMJE | July 21, 2005 | ||||
| Last Updated Date | June 23, 2006 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00122798 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improved Stroke Outcome at 6 Months | ||||
| Official Title ICMJE | Improved Stroke Outcome at 6 Months Attained by a Chain of Structured Acute Treatment With Integrated Rehabilitation and Supported Discharge | ||||
| Brief Summary | The investigators implemented a structured chain of acute stroke care with early integrated rehabilitation. The mortality at 6 months was lower (12%) compared to 23% in the International Stroke Trial (IST) and 39% (67%) of the patients were dead or dependent, which is superior compared to international data. |
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| Detailed Description | Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data. Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST) and recent international data. Results: At 6 months, mortality is significantly lower with 12 % (compared to 23 % in the IST trial) and only 39 % (67 %) of the patients are dead or dependent. Stroke severity is similar as in other study populations. Median LOS is 15 days in the acute clinic and 39 days in the rehabilitation institution. The psychosocial outcome compares favorably to a matched control group. Conclusions: A structured chain of acute stroke treatment overlapping with an early integrated rehabilitation is superior compared to national and international ischemic stroke trial data. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE | Stroke | ||||
| Intervention ICMJE | Procedure: Stroke treatment | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 200 | ||||
| Completion Date | January 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00122798 | ||||
| Other Study ID Numbers ICMJE | EK 50 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Kantonsspital Baden | ||||
| Collaborators ICMJE | RehaClinic Zurzach | ||||
| Investigators ICMJE |
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| Information Provided By | Kantonsspital Baden | ||||
| Verification Date | December 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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