Follow-up Pilot Study After a First Stroke

Stroke Clinical Trial

Official title:

Open, Randomized Follow-up Pilot Study After a First Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976001
• Other study ID #: VGSKAS-2300
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: September 11, 2009
• Start date: March 2003
• Est. completion date: February 2008

Study information

• Verified date: September 2009
• Source: Skaraborg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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. Endpoints are mortality, recurrent stroke and handicap measured with different scales.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 84 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Information, further rehabilitation, additional drugs to prevent recurrent stroke

• As the general practitioner wants to do

Locations

Country	Name	City	State
Sweden	Stroke unit, Department of Medicine, Lidkoeping hospital	Lidkoping

Sponsors (1)

Lead Sponsor	Collaborator
Skaraborg Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mortality		3.5 years	No
Secondary	Recurrent stroke		3.5 years	No