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Follow-up Pilot Study After a First Stroke

This study has been completed.
Sponsor:
Information provided by:
Skaraborg Hospital
ClinicalTrials.gov Identifier:
NCT00976001
First received: September 11, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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 Intervention
Stroke
 Other: Information, further rehabilitation, additional drugs to prevent recurrent stroke
Other: As the general practitioner wants to do

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open, Randomized Follow-up Pilot Study After a First Stroke

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by Skaraborg Hospital:

Primary Outcome Measures:
  • Total mortality [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrent stroke [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: March 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 84 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976001

Locations
Sweden
Stroke unit, Department of Medicine, Lidkoeping hospital
Lidkoping, Sweden, SE-531 85
Sponsors and Collaborators
Skaraborg Hospital
  More Information

No publications provided

Responsible Party: Lennart Welin, Department of Medicine, Lidkoeping Hospital, SE-531 85 Lidkoeping, Sweden
ClinicalTrials.gov Identifier: NCT00976001     History of Changes
Other Study ID Numbers: VGSKAS-2300
Study First Received: September 11, 2009
Last Updated: September 11, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Skaraborg Hospital:
Follow-up after stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013