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Early Supported Discharge After Stroke in Bergen

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Early supported discharge with day unit rehabilitation
Early supported discharge with home rehabilitation
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Early Supported Discharge, ESD, RCT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Day unit rehabilitation

Home rehabilitation

Treatment as usual

Arm Description

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 unit, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.

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 multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.

Patients will receive rehabilitation treatment after today's principles and routines.

Outcomes

Primary Outcome Measures

MRS
Modified Rankin Scale

Secondary Outcome Measures

NIHSS
National Institutes of Health Stroke Scale
BI
Barthel ADL Index
AMPS
Assessment of Motor and Process Skills
TIS
Trunk Impairment Scale
SIS
Stroke Impact Scale
RSS
Relative Stress Scale
PGIC
Patients' Global Impression of Change
SF-36
Short Form (36) Health Survey
MRS
Modified Rankin Scale
PASS (Postural Assessment Scale for Stroke)
5mTW (5 meter Timed Walk)
TUG (Timed Up and Go)
NRS (Numeric Rating Scale)
Norwegian Basic Test for Aphasia

Full Information

First Posted
October 10, 2008
Last Updated
February 24, 2014
Sponsor
Haukeland University Hospital
Collaborators
University of Bergen, Municipality of Bergen, Norway, Kavli Research Centre for Ageing and Dementia
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1. Study Identification

Unique Protocol Identification Number
NCT00771771
Brief Title
Early Supported Discharge After Stroke in Bergen
Official Title
Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital
Collaborators
University of Bergen, Municipality of Bergen, Norway, Kavli Research Centre for Ageing and Dementia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study is to evaluate the benefit of early supported discharge (ESD) in rehabilitation of stroke patients in two different outpatient modalities. In a collaborating study, changes in physical function as well as the patients' own perception of physical function, pain and fatigue will be studied. In further collaborating studies, health economics and organizational issues will also be evaluated.
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. In the collaborating study by physiotherapist Bente Gjelsvik a comparison between changes in trunk control, balance, walking and ADL 3 months post stroke, as well as the patients' perceptions of physical function, pain and fatigue, will be the main focus. To assess function, functional change and possible differences between different interventions, there is a need for reliable and valid outcome measures. As a basis for the use of the outcome measure Trunk Impairment Scale (TIS) in this study, the TIS has been translated into Norwegian, Trunk Impairment Scale - Norwegian version (TIS-NV) and will be examined for measurement properties using data from the above study as well as data from patients with brain damage recruited from the Department of Physical Rehabilitation Medicine, Haukeland University Hospital. An examination of a possible connection between localisation and size of the stroke and trunk control will also be performed, as characteristics of the stroke may have therapeutic implications for the choice of intervention for the individual patient. The research questions for the planned doctoral thesis for Bente Gjelsvik are therefore as follows: Is the TIS-NV reliable and valid in patients with brain damage? Are changes in trunk control, balance, walking and daily activities, as well as pain and fatigue 3 months post stroke different in patients who have received interventions from different courses of rehabilitation in the study "Early supported discharge after stroke in Bergen"? To which degree do the patients perceive problems related to balance, physical activity, walking, pain and fatigue? Is there a correlation between localization and size of the stroke as measured by magnetic tomography, and the patients' trunk control? Are initial localization and size of the stroke predictive for the patients' trunk control 3 months post stroke? Another collaborating project is carried out by PhD candidate Hedda Døli (Language outcome after stroke: lesion location, prognosis and consequences). The aim of her first study in the PhD project is to investigate the relationship between lesion location and aphasia severity one week post-stroke. Thereafter a follow-up study of the same patients 12 months post-stroke investigates the prognosis of aphasia and the variables that may influence recovery. In the third study the aim is to investigate the health-related quality of life and the occurrence of depression in patients with aphasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Early Supported Discharge, ESD, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day unit rehabilitation
Arm Type
Active Comparator
Arm Description
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 unit, and multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.
Arm Title
Home rehabilitation
Arm Type
Active Comparator
Arm Description
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 multidisciplinary policlinical follow-ups will be performed 3 and 6 months after inclusion.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Patients will receive rehabilitation treatment after today's principles and routines.
Intervention Type
Other
Intervention Name(s)
Early supported discharge with day unit rehabilitation
Intervention Description
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
Intervention Type
Other
Intervention Name(s)
Early supported discharge with home rehabilitation
Intervention Description
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
Primary Outcome Measure Information:
Title
MRS
Description
Modified Rankin Scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
NIHSS
Description
National Institutes of Health Stroke Scale
Time Frame
3, 6 and 12 months
Title
BI
Description
Barthel ADL Index
Time Frame
3, 6, 12 and 24 months
Title
AMPS
Description
Assessment of Motor and Process Skills
Time Frame
3 and 6 months
Title
TIS
Description
Trunk Impairment Scale
Time Frame
3 and 6 months
Title
SIS
Description
Stroke Impact Scale
Time Frame
12 months
Title
RSS
Description
Relative Stress Scale
Time Frame
12 months
Title
PGIC
Description
Patients' Global Impression of Change
Time Frame
12 and 24 months
Title
SF-36
Description
Short Form (36) Health Survey
Time Frame
12 and 24 months
Title
MRS
Description
Modified Rankin Scale
Time Frame
3, 12 and 24 months
Title
PASS (Postural Assessment Scale for Stroke)
Time Frame
3 and 6 months
Title
5mTW (5 meter Timed Walk)
Time Frame
3 and 6 months
Title
TUG (Timed Up and Go)
Time Frame
3 and 6 months
Title
NRS (Numeric Rating Scale)
Time Frame
3 and 6 months
Title
Norwegian Basic Test for Aphasia
Time Frame
3 and 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan S. Skouen, PhD
Organizational Affiliation
Haukeland University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22594689
Citation
Hofstad H, Naess H, Moe-Nilssen R, Skouen JS. Early supported discharge after stroke in Bergen (ESD Stroke Bergen): a randomized controlled trial comparing rehabilitation in a day unit or in the patients' homes with conventional treatment. Int J Stroke. 2013 Oct;8(7):582-7. doi: 10.1111/j.1747-4949.2012.00825.x. Epub 2012 May 18.
Results Reference
background
PubMed Identifier
22191850
Citation
Gjelsvik B, Breivik K, Verheyden G, Smedal T, Hofstad H, Strand LI. The Trunk Impairment Scale - modified to ordinal scales in the Norwegian version. Disabil Rehabil. 2012;34(16):1385-95. doi: 10.3109/09638288.2011.645113. Epub 2011 Dec 23.
Results Reference
result
PubMed Identifier
25528166
Citation
Hofstad H, Gjelsvik BE, Naess H, Eide GE, Skouen JS. Early supported discharge after stroke in Bergen (ESD Stroke Bergen): three and six months results of a randomised controlled trial comparing two early supported discharge schemes with treatment as usual. BMC Neurol. 2014 Dec 21;14:239. doi: 10.1186/s12883-014-0239-3.
Results Reference
derived
PubMed Identifier
24833680
Citation
Gjelsvik BE, Hofstad H, Smedal T, Eide GE, Naess H, Skouen JS, Frisk B, Daltveit S, Strand LI. Balance and walking after three different models of stroke rehabilitation: early supported discharge in a day unit or at home, and traditional treatment (control). BMJ Open. 2014 May 14;4(5):e004358. doi: 10.1136/bmjopen-2013-004358.
Results Reference
derived

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Early Supported Discharge After Stroke in Bergen

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