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
  Purpose

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.


Condition Intervention
Stroke
Other: Early supported discharge with day unit rehabilitation
Other: Early supported discharge with home rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • MRS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Modified Rankin Scale


Secondary Outcome Measures:
  • 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 ]

Enrollment: 306
Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
No Intervention: Treatment as usual
Patients will receive rehabilitation treatment after today's principles and routines.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771771

Locations
Norway
Haukeland University Hospital
Bergen, Norway, N-5021
Sponsors and Collaborators
Haukeland University Hospital
University of Bergen
Municipality of Bergen, Norway
Kavli Research Centre for Ageing and Dementia
Investigators
Study Director: Jan S. Skouen, PhD Haukeland University Hospital
  More Information

Publications:
Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00771771     History of Changes
Other Study ID Numbers: 18993
Study First Received: October 10, 2008
Last Updated: February 24, 2014
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Haukeland University Hospital:
Stroke
Rehabilitation
Early Supported Discharge
ESD
RCT

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 22, 2014