StrokePhase 2GOTVEDNCT01622205
GOThenburg Very Early Supported Discharged
A Phase 2 study testing Very early supported discharge (VESD) and Ordinary rehabilitation in people with Stroke, run by Göteborg University at 1 site in Sweden.
Trial summary
Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for more patient days than any other single condition in Swedish health care. The Swedish guidelines for stroke treatment, issued by the national board for health and welfare, recommend early supported discharge for people with mild… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Very early supported discharge (VESD) and Ordinary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to 30 Jun 2019
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed stroke according to WHO´s criteria
- > 18 years of age
- Living within 30 min from the stroke unit
- On day 2 NIHSS (National institute of health stroke scale) (22) of 0-16 points and Barthel 50-100 points.
- MoCA index < 26 if Barthel = 100.
Who cannot join
- NIHSS > 16
- Barthel < 50
- Life expectancy < 1 year (as with severe malignancy)
- Does not speak or communicate in Swedish prior to the incidence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Very Early Supported Discharge From a Stroke Unit in
Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for more patient days than any other single condition in Swedish health care. The Swedish guidelines for stroke treatment, issued by the national board for health and welfare, recommend early supported discharge for people with mild to moderate stroke. This is based on studies in which mean hospitalization was 18 days. The average length of stay in Sweden is 12 days. Policy makers would, however, like to shorten length of stay even further, and many patients are anxious to get home. Where and how to get support at home after discharge varies.
This study is a randomized controlled trial in which half of the subjects are randomly allocated to very early supported discharge and the other half receives usual treatment. The investigators believe that patients discharged very early with support will experience less anxiety compared with controls. The investigators believe that early supported discharge is safe and that there is no difference between groups in bodily function. In order to test differences between the groups, the study requires approximately 110 subjects.
Read more
Everyone who comes to the stroke unit at the hospital with a mild to moderate stroke can be recruited to the study. The intervention is having a team from the stroke unit visiting the patient's home and train him/her according to the individualized goals. The controls are discharged according to routine with support from primary care if needed. Assessments are made by therapists who are not involved in the training upon returning home, at 1 month, 3 to 12 months. The assessments include anxiety, motor activity, gait and balance, and ADL. Interviews will be done to highlight the subject's own experience.
It is important to evaluate new methods and organizational changes prior to their implementation in health care. The investigators hope to show that very early supported discharge with rehabilitation is safe and provides confidence and less anxiety. Then it is possible to introduce a method that simultaneously improves patient outcome and increases availability of hospital beds.
Read the detailed description
Stroke is a common condition that affects one in six people in the world during their lifetime. It is the physical condition that accounts for more patient days than any other single condition in Swedish health care, and stroke is the leading cause of disability in adults. The Swedish guidelines for stroke treatment, issued by the national board for health and welfare, recommend early supported discharge for people with mild to moderate stroke. It also recommends that the patients should be involved in their own care and rehabilitation, and that the effect on close relatives should be taken into account.
The recommendations by the National Board of Health and Welfare are based on older studies with an average hospitalization of 18 days prior to early supported discharge, compared tp 30 days for control patients. Today, however, the average stay of all stroke patients in Sweden is 12 days. Thus, there is a knowledge gap in the sense that the reality on which the previous studies are based no longer exists. Today, policy makers strive towards a shortened hospital stay, and many patients are anxious to get home. There are variations in the nature as well as the extent of the support available to the patient in his/her home.
This study is a randomized controlled trial in which half of the subjects are randomly allocated to very early supported discharge and the other half receives usual treatment. The investigators believe that patients discharged very early with support will experience less anxiety compared with controls. The investigators believe that early supported discharge is safe and that there is no difference between groups in bodily function. In order to test differences between the groups, the study requires approximately 110 subjects. All patients admitted to the stroke unit will be screened and those with mild to moderate stroke, with impaired ability to cope with activities of daily living (ADL) antigen because of motor function or thinking ability, can participate.
Very early supported discharge entails a training period when a team from the stroke unit visits the patient and trains any functions that are perceived awkward by the patient. The others are planned home with support from primary care practitioners if they are deemed to need it. Both groups get home care if necessary. Assessments are made by therapists who are not involved in the training upon returning home, at 1 month, 3 to 12 months. The projections include anxiety, motor activity, gait and balance, and ADL. The patients answer questions whether they think that the different abilities have evolved after stroke onset and rate their quality of life. Related questionnaires administered concern anxiety and perceived burden of caregivers. Interviews with participants and family members to hear what they think of the rehabilitation have also been done. A pilot study, conducted in 2010 with about 20 participants, showed that patients and families were very satisfied. They also said they felt safe when they knew that the guys from the unit would come home to them if needed.
The study is expected to take four years, of which 1 year has passed this summer. We expect enrollment to last 3 years. Each subject will be followed up during 12 months. The policy in Western Gotaland is that early supported discharge should be given to those who so desire. From the pilot study it has, however, been concluded that it is not yet clear how this can be implemented while maintaining a good and safe care.
When the project is finished, the investigators hope to show that patients with very early supported discharge are confident and satisfied with the care they have received and have lower levels of anxiety.
- Conditions
- Stroke
- Being tested
- Very early supported discharge (VESD), Ordinary rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very early supported discharge (VESD)Other
Also called VESD Very early supported discharge
A rehabilitation team made up of physiotherapists, occupational therapists and a stroke nurse from the stroke care unit continues the rehabilitation in the patient's home. The intervention has a person-centered approach which is based on who the person is: their context, their history, their next of kin, their individual strengths and weaknesses (28). Goal setting using questions as in the Canadian Occupational Performance Measure (29) takes part before the discharge. Examples of goals can be: to be able to go to the local store to buy milk, to be able to hang the laundry or to be able to travel on the tram to the daughter or how to manage the bills.
Ordinary rehabilitationOther
Also called C Control
Ordinary rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Early supported discharge Receives: Other: Very early supported discharge (VESD) |
| Control | Other | Ordinary rehabilitation Receives: Other: Ordinary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression (HADS)
Anxiety is main outcome
Measured: At 1 month, 3 months and 12 months, change from baseline
Secondary outcomes (5)
Barthel index
Measured: At 1 month, 3 months and 12 months
Balance
Measured: At 1 month, 3 months and 12 months
EQ5D
Health related Quality of life
Measured: At 1 month, 3 months and 12 months
Impact of stroke
SIS
Measured: At 1 month, 3 months and 12 months
Re-hospitalisation
Measured: At 1 month, 3 months 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 posted19 Jun 2012 (estimated)
- Study startMay 2011
- Primary completion31 Dec 2017
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Very early supported discharge vs ordinary discharge
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katharina Stibrant Sunnerhagen, MD, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622205
- Sponsor's protocol ID
- GOTVED
- Acronym
- GOTVED
- Status last verified
- Apr 2025
- First submitted
- 24 May 2012
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Rafsten L, Palstam A, Sunnerhagen KS. Gothenburg very early supported discharge: evaluating differences in costs and environmental impact due to rehabilitation consumption during the first year in patients hospitalized due to mild stroke. BMC Health Serv Res. 2025 Mar 19;25(1):406. doi: 10.1186/s12913-025-12509-y.
PubMed 40108578Nelsone L, Rafsten L, Abzhandadze T, Sunnerhagen KS. A cohort study on anxiety and perceived recovery 3 and 12 months after mild to moderate stroke. Front Neurol. 2023 Oct 10;14:1273864. doi: 10.3389/fneur.2023.1273864. eCollection 2023.
PubMed 37900595Rafsten L, Danielsson A, Sunnerhagen KS. Self-perceived postural balance correlates with postural balance and anxiety during the first year after stroke: a part of the randomized controlled GOTVED study. BMC Neurol. 2020 Nov 9;20(1):410. doi: 10.1186/s12883-020-01982-z.
PubMed 33167877Buvarp D, Rafsten L, Sunnerhagen KS. Predicting Longitudinal Progression in Functional Mobility After Stroke: A Prospective Cohort Study. Stroke. 2020 Jul;51(7):2179-2187. doi: 10.1161/STROKEAHA.120.029913. Epub 2020 Jun 17.
PubMed 32568652Rafsten L, Danielsson A, Nordin A, Bjorkdahl A, Lundgren-Nilsson A, Larsson MEH, Sunnerhagen KS. Gothenburg Very Early Supported Discharge study (GOTVED): a randomised controlled trial investigating anxiety and overall disability in the first year after stroke. BMC Neurol. 2019 Nov 9;19(1):277. doi: 10.1186/s12883-019-1503-3.
PubMed 31706292Sunnerhagen KS, Danielsson A, Rafsten L, Bjorkdahl A, Axelsson AB, Nordin A, Petersson CA, Lundgren-Nilsson A, Frojd K. Gothenburg very early supported discharge study (GOTVED) NCT01622205: a block randomized trial with superiority design of very early supported discharge for patients with stroke. BMC Neurol. 2013 Jun 24;13:66. doi: 10.1186/1471-2377-13-66.
PubMed 23800106
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Very Early Supported Discharge From a Stroke Unit in
- ClinicalTrials.gov ID
- NCT01622205
- Acronym / sponsor ID
- GOTVED / GOTVED
- Conditions
- Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Jun 2012 (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.
Stroke is a generic term for cerebral infarction and cerebral haemorrhage and accounts for more patient days than any other single condition in Swedish health care. The Swedish guidelines for stroke treatment, issued by the national board for health and welfare, recommend early supported discharge for people with mild to moderate stroke. This is based on studies in which mean hospitalization was 18 days. The average length of stay in Sweden is 12 days. Policy makers would, however, like to shorten length of stay even further, and many patients are anxious to get home. Where and how to get support at home after discharge varies.
This study is a randomized controlled trial in which half of the subjects are randomly allocated to very early supported discharge and the other half receives usual treatment. The investigators believe that patients discharged very early with support will experience less anxiety compared with controls. The investigators believe that early supported discharge is safe and that there is no difference between groups in bodily function. In order to test differences between the groups, the study requires approximately 110 subjects.
Everyone who comes to the stroke unit at the hospital with a mild to moderate stroke can be recruited to the study. The intervention is having a team from the stroke unit visiting the patient's home and train him/her according to the individualized goals. The controls are discharged according to routine with support from primary care if needed. Assessments are made by therapists who are not involved in the training upon returning home, at 1 month, 3 to 12 months. The assessments include anxiety, motor activity, gait and balance, and ADL. Interviews will be done to highlight the subject's own experience.
It is important to evaluate new methods and organizational changes prior to their implementation in health care. The investigators hope to show that very early supported discharge with rehabilitation is safe and provides confidence and less anxiety. Then it is possible to introduce a method that simultaneously improves patient outcome and increases availability of hospital beds.
Detailed description
Stroke is a common condition that affects one in six people in the world during their lifetime. It is the physical condition that accounts for more patient days than any other single condition in Swedish health care, and stroke is the leading cause of disability in adults. The Swedish guidelines for stroke treatment, issued by the national board for health and welfare, recommend early supported discharge for people with mild to moderate stroke. It also recommends that the patients should be involved in their own care and rehabilitation, and that the effect on close relatives should be taken into account.
The recommendations by the National Board of Health and Welfare are based on older studies with an average hospitalization of 18 days prior to early supported discharge, compared tp 30 days for control patients. Today, however, the average stay of all stroke patients in Sweden is 12 days. Thus, there is a knowledge gap in the sense that the reality on which the previous studies are based no longer exists. Today, policy makers strive towards a shortened hospital stay, and many patients are anxious to get home. There are variations in the nature as well as the extent of the support available to the patient in his/her home.
This study is a randomized controlled trial in which half of the subjects are randomly allocated to very early supported discharge and the other half receives usual treatment. The investigators believe that patients discharged very early with support will experience less anxiety compared with controls. The investigators believe that early supported discharge is safe and that there is no difference between groups in bodily function. In order to test differences between the groups, the study requires approximately 110 subjects. All patients admitted to the stroke unit will be screened and those with mild to moderate stroke, with impaired ability to cope with activities of daily living (ADL) antigen because of motor function or thinking ability, can participate.
Very early supported discharge entails a training period when a team from the stroke unit visits the patient and trains any functions that are perceived awkward by the patient. The others are planned home with support from primary care practitioners if they are deemed to need it. Both groups get home care if necessary. Assessments are made by therapists who are not involved in the training upon returning home, at 1 month, 3 to 12 months. The projections include anxiety, motor activity, gait and balance, and ADL. The patients answer questions whether they think that the different abilities have evolved after stroke onset and rate their quality of life. Related questionnaires administered concern anxiety and perceived burden of caregivers. Interviews with participants and family members to hear what they think of the rehabilitation have also been done. A pilot study, conducted in 2010 with about 20 participants, showed that patients and families were very satisfied. They also said they felt safe when they knew that the guys from the unit would come home to them if needed.
The study is expected to take four years, of which 1 year has passed this summer. We expect enrollment to last 3 years. Each subject will be followed up during 12 months. The policy in Western Gotaland is that early supported discharge should be given to those who so desire. From the pilot study it has, however, been concluded that it is not yet clear how this can be implemented while maintaining a good and safe care.
When the project is finished, the investigators hope to show that patients with very early supported discharge are confident and satisfied with the care they have received and have lower levels of anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Very early supported discharge vs ordinary discharge
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Very early supported discharge (VESD)Early supported discharge |
| Control | Other | Other: Ordinary rehabilitationOrdinary rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed stroke according to WHO´s criteria
- > 18 years of age
- Living within 30 min from the stroke unit
- On day 2 NIHSS (National institute of health stroke scale) (22) of 0-16 points and Barthel 50-100 points.
- MoCA index < 26 if Barthel = 100.
Key exclusion criteria (4 listed)
- NIHSS > 16
- Barthel < 50
- Life expectancy < 1 year (as with severe malignancy)
- Does not speak or communicate in Swedish prior to the incidence
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 |
|---|---|---|
| Very early supported discharge (VESD)Also: VESD Very early supported dischargeA rehabilitation team made up of physiotherapists, occupational therapists and a stroke nurse from the stroke care unit continues the rehabilitation in the patient's home. The intervention has a person-centered approach which is based on who the person is: their context, their history, their next of kin, their individual strengths and weaknesses (28). Goal setting using questions as in the Canadian Occupational Performance Measure (29) takes part before the discharge. Examples of goals can be: to be able to go to the local store to buy milk, to be able to hang the laundry or to be able to travel on the tram to the daughter or how to manage the bills. | Other | Active |
| Ordinary rehabilitationAlso: C ControlOrdinary rehabilitation | Other | Control |
Primary outcome
Anxiety and depression (HADS)
Time frame: At 1 month, 3 months and 12 months, change from baseline
Anxiety is main outcome
5 secondary outcomes
Barthel index
Time frame: At 1 month, 3 months and 12 months
Balance
Time frame: At 1 month, 3 months and 12 months
EQ5D
Time frame: At 1 month, 3 months and 12 months
Impact of stroke
Time frame: At 1 month, 3 months and 12 months
Re-hospitalisation
Time frame: At 1 month, 3 months 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 4 Apr 2025.
- Derived from this study: PubMed 40108578Rafsten L, Palstam A, Sunnerhagen KS. Gothenburg very early supported discharge: evaluating differences in costs and environmental impact due to rehabilitation consumption during the first year in patients hospitalized due to mild stroke. BMC Health Serv Res. 2025 Mar 19;25(1):406. doi: 10.1186/s12913-025-12509-y.
- Derived from this study: PubMed 37900595Nelsone L, Rafsten L, Abzhandadze T, Sunnerhagen KS. A cohort study on anxiety and perceived recovery 3 and 12 months after mild to moderate stroke. Front Neurol. 2023 Oct 10;14:1273864. doi: 10.3389/fneur.2023.1273864. eCollection 2023.
- Derived from this study: PubMed 33167877Rafsten L, Danielsson A, Sunnerhagen KS. Self-perceived postural balance correlates with postural balance and anxiety during the first year after stroke: a part of the randomized controlled GOTVED study. BMC Neurol. 2020 Nov 9;20(1):410. doi: 10.1186/s12883-020-01982-z.
- Derived from this study: PubMed 32568652Buvarp D, Rafsten L, Sunnerhagen KS. Predicting Longitudinal Progression in Functional Mobility After Stroke: A Prospective Cohort Study. Stroke. 2020 Jul;51(7):2179-2187. doi: 10.1161/STROKEAHA.120.029913. Epub 2020 Jun 17.
- Derived from this study: PubMed 31706292Rafsten L, Danielsson A, Nordin A, Bjorkdahl A, Lundgren-Nilsson A, Larsson MEH, Sunnerhagen KS. Gothenburg Very Early Supported Discharge study (GOTVED): a randomised controlled trial investigating anxiety and overall disability in the first year after stroke. BMC Neurol. 2019 Nov 9;19(1):277. doi: 10.1186/s12883-019-1503-3.
- Derived from this study: PubMed 23800106Sunnerhagen KS, Danielsson A, Rafsten L, Bjorkdahl A, Axelsson AB, Nordin A, Petersson CA, Lundgren-Nilsson A, Frojd K. Gothenburg very early supported discharge study (GOTVED) NCT01622205: a block randomized trial with superiority design of very early supported discharge for patients with stroke. BMC Neurol. 2013 Jun 24;13:66. doi: 10.1186/1471-2377-13-66.
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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.
Katharina Stibrant Sunnerhagen, MD, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Very early supported discharge (VESD) and Ordinary rehabilitation in people with Stroke, run by Göteborg University at 1 site in Sweden.
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 4 Apr 2025. 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 Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anxiety and depression (HADS) (time frame: At 1 month, 3 months and 12 months, change from baseline). 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 NCT01622205, which also lists 6 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 4 Apr 2025.