Early Supported Discharge After Stroke in Bergen

Study Overview
=================
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.

Official Title
-----------------
Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Early supported discharge with day unit rehabilitation
* Other: Early supported discharge with home rehabilitation


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day unit rehabilitation<br>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. | Other: Early supported discharge with day unit rehabilitation<br>* Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit<br>|
| Active Comparator: Home rehabilitation<br>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. | Other: Early supported discharge with home rehabilitation<br>* Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home<br>|
| No Intervention: Treatment as usual<br>Patients will receive rehabilitation treatment after today's principles and routines. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRS | Modified Rankin Scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS | National Institutes of Health Stroke Scale | 3, 6 and 12 months | 
| BI | Barthel ADL Index | 3, 6, 12 and 24 months | 
| AMPS | Assessment of Motor and Process Skills | 3 and 6 months | 
| TIS | Trunk Impairment Scale | 3 and 6 months | 
| SIS | Stroke Impact Scale | 12 months | 
| RSS | Relative Stress Scale | 12 months | 
| PGIC | Patients' Global Impression of Change | 12 and 24 months | 
| SF-36 | Short Form (36) Health Survey | 12 and 24 months | 
| MRS | Modified Rankin Scale | 3, 12 and 24 months | 
| PASS (Postural Assessment Scale for Stroke) |  | 3 and 6 months | 
| 5mTW (5 meter Timed Walk) |  | 3 and 6 months | 
| TUG (Timed Up and Go) |  | 3 and 6 months | 
| NRS (Numeric Rating Scale) |  | 3 and 6 months | 
| Norwegian Basic Test for Aphasia |  | 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Rehabilitation, Early Supported Discharge, ESD, RCT