Extended Stroke Unit Service in Bergen - Full Text View

Sponsor:	Haukeland University Hospital
Collaborators:	University of Bergen Municipality of Bergen, Norway Kavli Research Centre for Ageing and Dementia Innovest AS
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00771771

Purpose

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
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.

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities Rehabilitation

U.S. FDA Resources

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:

Modified Rankin Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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
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.	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
Treatment as usual: No Intervention Patients will receive rehabilitation treatment after today's principles and routines.

Detailed Description:

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:

ESD with treatment at a day institution until 4 hrs. per day for up to 5 weeks
ESD with treatment in the patients' home until 4 hrs. per day for up to 5 weeks
Rehabilitation treatment "as usual", with a longer hospital stay, but without any specific treatment or follow-up after discharge

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Living in own home in the community of Bergen, Norway
Inclusion within 1-7 days (24-168 hours) after debut of symptoms
Inclusion within 6-120 hours after admission to Department of Neurology
NIHSS score 2-26 at inclusion OR NIHSS score < 2 if Modified Rankin Scale is 2 or higher when being 0 before the stroke
The patient must be awake and informed consent must be given by patient or relatives

Exclusion Criteria:

Serious psychic illness
Serious drug abuse
Serious medical conditions that can influence the patients' cerebrovascular disease or rehabilitation
Poor knowledge of the Norwegian language

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771771

Contacts

Contact: Jan S. Skouen, PhD	4755918500	jan.skouen@helse-bergen.no
Contact: Håkon Hofstad, MD	4755918416	hhof@helse-bergen.no

Locations

Norway
Haukeland University Hospital	Recruiting
Bergen, Norway, N-5021
Haukeland University Hospital	Recruiting
Bergen, Norway, N-5021
Principal Investigator: Jan S. Skouen, PhD
Sub-Investigator: Håkon Hofstad, MD

Sponsors and Collaborators

Haukeland University Hospital

University of Bergen

Municipality of Bergen, Norway

Kavli Research Centre for Ageing and Dementia

Innovest AS

Investigators

Study Director:

Jan S. Skouen, PhD

Haukeland University Hospital

More Information

No publications provided

Responsible Party:	Haukeland University Hospital, Bergen, Norway ( Dr. Jan Sture Skouen )
Study ID Numbers:	18993
Study First Received:	October 10, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00771771 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Haukeland University Hospital:

Stroke
Rehabilitation
Early Supported Discharge
ESD

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 27, 2009