Back to resultsFollow-up Pilot Study After a First Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Information, further rehabilitation, additional drugs to prevent recurrent stroke
As the general practitioner wants to do
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring Follow-up after stroke
Eligibility Criteria
Inclusion Criteria:
- first stroke (ischemic or hemorrhagic)
- age below 85 years
- living at home before the stroke
Exclusion Criteria:
- modified Rankin scale 5 points
- other severe disease
- expected survival less than one year
- severe dementia
- drug or alcohol abuse
Sites / Locations
- Stroke unit, Department of Medicine, Lidkoeping hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Follow-up at an out-patient stroke unit
Follow-up with the general practitioner
Arm Description
Information, measurement of handicap, further rehabilitation efforts, drug therapy for secondary prevention of stroke.
Outcomes
Primary Outcome Measures
Total mortality
Secondary Outcome Measures
Recurrent stroke
Full Information
NCT ID
NCT00976001
First Posted
September 11, 2009
Last Updated
September 11, 2009
Sponsor
Skaraborg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00976001
Brief Title
Follow-up Pilot Study After a First Stroke
Official Title
Open, Randomized Follow-up Pilot Study After a First Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Skaraborg Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. Endpoints are mortality, recurrent stroke and handicap measured with different scales.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Follow-up after stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Follow-up at an out-patient stroke unit
Arm Type
Other
Arm Description
Information, measurement of handicap, further rehabilitation efforts, drug therapy for secondary prevention of stroke.
Arm Title
Follow-up with the general practitioner
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Information, further rehabilitation, additional drugs to prevent recurrent stroke
Intervention Type
Other
Intervention Name(s)
As the general practitioner wants to do
Primary Outcome Measure Information:
Title
Total mortality
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Recurrent stroke
Time Frame
3.5 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first stroke (ischemic or hemorrhagic)
age below 85 years
living at home before the stroke
Exclusion Criteria:
modified Rankin scale 5 points
other severe disease
expected survival less than one year
severe dementia
drug or alcohol abuse
Facility Information:
Facility Name
Stroke unit, Department of Medicine, Lidkoeping hospital
City
Lidkoping
ZIP/Postal Code
SE-531 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Follow-up Pilot Study After a First Stroke
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