Clinical trial NCT00771771: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Early Supported Discharge
ESD
RCT
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Municipality of Bergen, Norway
name: Kavli Research Centre for Ageing and Dementia
First posted: 2008-10-13
Enrollment: 306
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. Is the TIS-NV reliable and valid in patients with brain damage?
2. 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?
3. 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.

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

Primary outcomes:
measure: MRS
timeFrame: 6 months
Secondary outcomes:
measure: NIHSS
timeFrame: 3, 6 and 12 months
measure: BI
timeFrame: 3, 6, 12 and 24 months
measure: AMPS
timeFrame: 3 and 6 months
measure: TIS
timeFrame: 3 and 6 months
measure: SIS
timeFrame: 12 months
measure: RSS
timeFrame: 12 months
measure: PGIC
timeFrame: 12 and 24 months
measure: SF-36
timeFrame: 12 and 24 months
measure: MRS
timeFrame: 3, 12 and 24 months
measure: PASS (Postural Assessment Scale for Stroke)
timeFrame: 3 and 6 months
measure: 5mTW (5 meter Timed Walk)
timeFrame: 3 and 6 months
measure: TUG (Timed Up and Go)
timeFrame: 3 and 6 months
measure: NRS (Numeric Rating Scale)
timeFrame: 3 and 6 months
measure: Norwegian Basic Test for Aphasia
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Jan S. Skouen, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.