StrokeNCT00976001
Follow-up Pilot Study After a First Stroke
A study testing Information, further rehabilitation, additional drugs to prevent recurrent stroke and As the general practitioner wants to do in people with Stroke, run by Skaraborg Hospital at 1 site in Sweden.
Trial summary
This is a randomized follow-up study after discharge from a stroke unit after a first stroke. The patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. The hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. Read more about this study
- Who is it for?
- Ages Up to 84 years
- Conditions the study is for
- Stroke
- What is being tested?
- Information, further rehabilitation, additional drugs to prevent recurrent stroke and As the general practitioner wants to do
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2003to Feb 2008
- 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 Up to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- first stroke (ischemic or hemorrhagic)
- age below 85 years
- living at home before the stroke
Who cannot join
- modified Rankin scale 5 points
- other severe disease
- expected survival less than one year
- severe dementia
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Stroke unit, Department of Medicine, Lidkoeping hospital
Lidköping, SE-531 85
About this study
Official title: Open, Randomized Follow-up Pilot Study After a First Stroke
This is a randomized follow-up study after discharge from a stroke unit after a first stroke. The patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. The hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap measured with different scales.
- Conditions
- Stroke
- Being tested
- Information, further rehabilitation, additional drugs to prevent recurrent stroke, As the general practitioner wants to do
- Keywords
- Follow-up after stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information, further rehabilitation, additional drugs to prevent recurrent strokeOther
As the general practitioner wants to doOther
| Study group | Role | What they receive |
|---|---|---|
| Follow-up at an out-patient stroke unit | Other | Information, measurement of handicap, further rehabilitation efforts, drug therapy for secondary prevention of stroke. Receives: Other: Information, further rehabilitation, additional drugs to prevent recurrent stroke |
| Follow-up with the general practitioner | Other | Not described Receives: Other: As the general practitioner wants to do |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mortality
Measured: 3.5 years
Secondary outcomes (1)
Recurrent stroke
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startMar 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skaraborg Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976001
- Sponsor's protocol ID
- VGSKAS-2300
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 14 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized Follow-up Pilot Study After a First Stroke
- ClinicalTrials.gov ID
- NCT00976001
- Acronym / sponsor ID
- VGSKAS-2300
- Conditions
- Stroke
- Keywords
- Follow-up after stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Skaraborg HospitalOther government
- Study start
- Mar 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 14 Sep 2009 (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.
This is a randomized follow-up study after discharge from a stroke unit after a first stroke. The patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. The hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap measured with different scales.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-up at an out-patient stroke unit | Other | Other: Information, further rehabilitation, additional drugs to prevent recurrent strokeInformation, measurement of handicap, further rehabilitation efforts, drug therapy for secondary prevention of stroke. |
| Follow-up with the general practitioner | Other | Other: As the general practitioner wants to do |
Who may qualify
- Ages
- Up to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- first stroke (ischemic or hemorrhagic)
- age below 85 years
- living at home before the stroke
Key exclusion criteria (5 listed)
- modified Rankin scale 5 points
- other severe disease
- expected survival less than one year
- severe dementia
- drug or alcohol abuse
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 |
|---|---|---|
| Information, further rehabilitation, additional drugs to prevent recurrent stroke | Other | Follow-up at an out-patient stroke unit |
| As the general practitioner wants to do | Other | Follow-up with the general practitioner |
Primary outcome
Total mortality
Time frame: 3.5 years
1 secondary outcome
Recurrent stroke
Time frame: 3.5 years
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 14 Sep 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information, further rehabilitation, additional drugs to prevent recurrent stroke and As the general practitioner wants to do in people with Stroke, run by Skaraborg Hospital 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 3 inclusion and 5 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 14 Sep 2009. 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.
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?
Total mortality (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2009.