StrokeNCT00771771
Early Supported Discharge After Stroke in Bergen
A study testing Early supported discharge with day unit rehabilitation and Early supported discharge with home rehabilitation in people with Stroke, run by Haukeland University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Early supported discharge with day unit rehabilitation and Early supported discharge with home rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious psychic illness
- Serious drug abuse
- Serious medical conditions that can influence the patients' cerebrovascular disease or rehabilitation
- Poor knowledge of the Norwegian language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Early supported discharge with day unit rehabilitation, Early supported discharge with home rehabilitation
- Keywords
- Stroke, Rehabilitation, Early Supported Discharge, ESD, RCT
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early supported discharge with day unit rehabilitationOther
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit
Early supported discharge with home rehabilitationOther
Treatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home
| Study group | Role | What they receive |
|---|---|---|
| Day unit rehabilitation | Active comparator | 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. Receives: Other: Early supported discharge with day unit rehabilitation |
| Home rehabilitation | Active comparator | 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. Receives: Other: Early supported discharge with home rehabilitation |
| Treatment as usual | No intervention | Patients will receive rehabilitation treatment after today's principles and routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRS
Modified Rankin Scale
Measured: 6 months
Secondary outcomes (14)
NIHSS
National Institutes of Health Stroke Scale
Measured: 3, 6 and 12 months
BI
Barthel ADL Index
Measured: 3, 6, 12 and 24 months
AMPS
Assessment of Motor and Process Skills
Measured: 3 and 6 months
TIS
Trunk Impairment Scale
Measured: 3 and 6 months
SIS
Stroke Impact Scale
Measured: 12 months
RSS
Relative Stress Scale
Measured: 12 months
PGIC
Patients' Global Impression of Change
Measured: 12 and 24 months
SF-36
Short Form (36) Health Survey
Measured: 12 and 24 months
MRS
Modified Rankin Scale
Measured: 3, 12 and 24 months
PASS (Postural Assessment Scale for Stroke)
Measured: 3 and 6 months
5mTW (5 meter Timed Walk)
Measured: 3 and 6 months
TUG (Timed Up and Go)
Measured: 3 and 6 months
NRS (Numeric Rating Scale)
Measured: 3 and 6 months
Norwegian Basic Test for Aphasia
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Municipality of Bergen, Norway, Kavli Research Centre for Ageing and Dementia
- Responsible party
- Sponsor
- Investigators
- Jan S. Skouen, PhD, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771771
- Sponsor's protocol ID
- 18993
- Status last verified
- Feb 2014
- First submitted
- 10 Oct 2008
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22594689Gjelsvik 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.
PubMed 22191850Hofstad 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.
PubMed 25528166Gjelsvik 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.
PubMed 24833680
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.
- ClinicalTrials.gov ID
- NCT00771771
- Acronym / sponsor ID
- 18993
- Conditions
- Stroke
- Keywords
- Stroke, Rehabilitation, Early Supported Discharge, ESD, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, Municipality of Bergen, Norway, Kavli Research Centre for Ageing and Dementia
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Day unit rehabilitation | Active comparator | Other: Early supported discharge with day unit rehabilitationDischarge 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. |
| Home rehabilitation | Active comparator | Other: Early supported discharge with home rehabilitationDischarge 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. |
| Treatment as usual | No intervention | –Patients will receive rehabilitation treatment after today's principles and routines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Serious psychic illness
- Serious drug abuse
- Serious medical conditions that can influence the patients' cerebrovascular disease or rehabilitation
- Poor knowledge of the Norwegian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early supported discharge with day unit rehabilitationTreatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in a day unit | Other | Day unit rehabilitation |
| Early supported discharge with home rehabilitationTreatment by physiotherapist and occupational therapist up to 4 hours a day for up to 5 weeks in the patient's home | Other | Home rehabilitation |
Primary outcome
MRS
Time frame: 6 months
Modified Rankin Scale
14 secondary outcomes
NIHSS
Time frame: 3, 6 and 12 months
BI
Time frame: 3, 6, 12 and 24 months
AMPS
Time frame: 3 and 6 months
TIS
Time frame: 3 and 6 months
SIS
Time frame: 12 months
RSS
Time frame: 12 months
PGIC
Time frame: 12 and 24 months
SF-36
Time frame: 12 and 24 months
MRS
Time frame: 3, 12 and 24 months
PASS (Postural Assessment Scale for Stroke)
Time frame: 3 and 6 months
5mTW (5 meter Timed Walk)
Time frame: 3 and 6 months
TUG (Timed Up and Go)
Time frame: 3 and 6 months
NRS (Numeric Rating Scale)
Time frame: 3 and 6 months
Norwegian Basic Test for Aphasia
Time frame: 3 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Background: PubMed 22594689Hofstad 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 publication: PubMed 22191850Gjelsvik 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.
- Derived from this study: PubMed 25528166Hofstad 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.
- Derived from this study: PubMed 24833680Gjelsvik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan S. Skouen, PhD study director
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early supported discharge with day unit rehabilitation and Early supported discharge with home rehabilitation in people with Stroke, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00771771, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2014.