Extended Stroke Unit Service in Bergen - Tabular View

Tracking Information

First Received Date ^ICMJE

October 10, 2008

Last Updated Date

April 30, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Modified Rankin Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00771771 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Extended Stroke Unit Service in Bergen

Official Title ^ICMJE

Extended Stroke Unit Service in Bergen. A RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Other: Early supported discharge with day institution rehabilitation
Other: Early supported discharge with home rehabilitation

Study Arms / Comparison Groups

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.
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.
No Intervention: Patients will receive rehabilitation treatment after today's principles and routines.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

December 2013

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00771771

Responsible Party

Dr. Jan Sture Skouen, Haukeland University Hospital, Bergen, Norway

Study ID Numbers ^ICMJE

18993

Study Sponsor ^ICMJE

Haukeland University Hospital

Collaborators ^ICMJE

University of Bergen
Municipality of Bergen, Norway
Kavli Research Centre for Ageing and Dementia
Innovest AS

Investigators ^ICMJE

Study Director:

Jan S. Skouen, PhD

Haukeland University Hospital

Information Provided By

Haukeland University Hospital

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP