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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014