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Early Supported Discharge After Stroke in Bergen

This study has been completed.
Sponsor:
Collaborators:
University of Bergen
Municipality of Bergen, Norway
Kavli Research Centre for Ageing and Dementia
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00771771
First received: October 10, 2008
Last updated: February 24, 2014
Last verified: February 2014

October 10, 2008
February 24, 2014
December 2008
June 2012   (final data collection date for primary outcome measure)
MRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Modified Rankin Scale
Modified Rankin Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00771771 on ClinicalTrials.gov Archive Site
  • NIHSS [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    National Institutes of Health Stroke Scale
  • BI [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Barthel ADL Index
  • AMPS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Assessment of Motor and Process Skills
  • TIS [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Trunk Impairment Scale
  • SIS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Stroke Impact Scale
  • RSS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Relative Stress Scale
  • PGIC [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Patients' Global Impression of Change
  • SF-36 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Short Form (36) Health Survey
  • MRS [ Time Frame: 3, 12 and 24 months ] [ Designated as safety issue: No ]
    Modified Rankin Scale
  • PASS (Postural Assessment Scale for Stroke) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • 5mTW (5 meter Timed Walk) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • TUG (Timed Up and Go) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • NRS (Numeric Rating Scale) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Norwegian Basic Test for Aphasia [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Early Supported Discharge After Stroke in Bergen
Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
  • Other: Early supported discharge with day unit rehabilitation
    Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
  • 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
  • Active Comparator: Day unit rehabilitation
    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.
    Intervention: Other: Early supported discharge with day unit rehabilitation
  • Active Comparator: Home rehabilitation
    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.
    Intervention: Other: Early supported discharge with home rehabilitation
  • No Intervention: Treatment as usual
    Patients will receive rehabilitation treatment after today's principles and routines.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
December 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00771771
18993
No
Haukeland University Hospital
Haukeland University Hospital
  • University of Bergen
  • Municipality of Bergen, Norway
  • Kavli Research Centre for Ageing and Dementia
Study Director: Jan S. Skouen, PhD Haukeland University Hospital
Haukeland University Hospital
February 2014

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