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Follow-up Pilot Study After a First Stroke

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ClinicalTrials.gov Identifier: NCT00976001
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : September 14, 2009
Sponsor:
Information provided by:
Skaraborg Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Other: Information, further rehabilitation, additional drugs to prevent recurrent stroke Other: As the general practitioner wants to do Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Open, Randomized Follow-up Pilot Study After a First Stroke
Study Start Date : March 2003
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008
Arms and Interventions
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Arm Intervention/treatment
Follow-up at an out-patient stroke unit
Information, measurement of handicap, further rehabilitation efforts, drug therapy for secondary prevention of stroke.
 Other: Information, further rehabilitation, additional drugs to prevent recurrent stroke
Follow-up with the general practitioner Other: As the general practitioner wants to do


Outcome Measures
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Primary Outcome Measures :
  1. Total mortality [ Time Frame: 3.5 years ]

Secondary Outcome Measures :
  1. Recurrent stroke [ Time Frame: 3.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 84 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976001


Locations
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Sweden
Stroke unit, Department of Medicine, Lidkoeping hospital
Lidkoping, Sweden, SE-531 85
Sponsors and Collaborators
Skaraborg Hospital
More Information
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Responsible Party: Lennart Welin, Department of Medicine, Lidkoeping Hospital, SE-531 85 Lidkoeping, Sweden
ClinicalTrials.gov Identifier: NCT00976001    
Other Study ID Numbers: VGSKAS-2300
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: September 14, 2009
Last Verified: September 2009
Keywords provided by Skaraborg Hospital:
Follow-up after stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases