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Sponsors and Collaborators: |
Haukeland University Hospital University of Bergen Municipality of Bergen, Norway Municipality of Fjell, Norway Municipality of Os, Hordaland, Norway Kavli Research Centre for Ageing and Dementia Innovest AS |
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Information provided by: | Haukeland University Hospital |
ClinicalTrials.gov Identifier: | NCT00771771 |
The purpose of this study is to evaluate the benefit of early supported discharge (ESD) in rehabilitation of stroke patients in two different outpatient modalities.
Condition | Intervention |
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Stroke |
Other: Early supported discharge with day institution rehabilitation Other: Early supported discharge with home rehabilitation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Extended Stroke Unit Service in Bergen. A RCT Looking at the Collaboration Between Hospital Service and Primary Health Care. |
Estimated Enrollment: | 750 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Day institution rehabilitation: Experimental
Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation in a day institution, and systematic multidisciplinary policlinical follow-ups will be performed 2 and 6 months after inclusion.
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Other: Early supported discharge with day institution rehabilitation
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day institution
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Home rehabilitation: Experimental
Discharge from the hospital to the patients' homes as soon as possible, supported by an out-patient ambulatory coordinating multidisciplinary team. The patients will be offered rehabilitation treatment in their homes, and systematic multidisciplinary policlinical follow-ups will be performed 2 and 6 months after inclusion.
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Other: Early supported discharge with home rehabilitation
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
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Treatment as usual: No Intervention
Patients will receive rehabilitation treatment after today's principles and routines.
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Early supported discharge (ESD) seems to be at least as effective as hospital rehabilitation after stroke, and possibly better. In this study patients with recent stroke will be randomized to one of three different treatment arms:
The patients in the two ESD arms will in addition be followed closely by a multidisciplinary coordinating team during the stay in hospital and the 5 week period of treatment after discharge, and they will be offered follow-ups at 3 and 6 months after inclusion into the study.
Patients in all 3 arms will be systematically examined with a set of measuring instruments as well as objective physical and function tests. This will be performed at inclusion and at 3, 6, 12 and 24 months after inclusion.
Health economics and organizational issues will also be evaluated in this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan S. Skouen, PhD | 4755918500 | jan.skouen@helse-bergen.no |
Contact: Halvor Næss, PhD | 4755975040 | haln@helse-bergen.no |
Norway | |
Haukeland University Hospital | |
Bergen, Norway, N-5021 |
Study Director: | Jan S. Skouen, PhD | Haukeland University Hospital |
Responsible Party: | Haukeland University Hospital, Bergen, Norway ( Dr. Jan Sture Skouen ) |
Study ID Numbers: | 18993 |
Study First Received: | October 10, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00771771 |
Health Authority: | Norway: Norwegian Social Science Data Services |
Stroke Rehabilitation Early Supported Discharge ESD |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |