NCT00976001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

Enrollment Period

4.9 years

First QC Date

September 11, 2009

Last Update Submit

September 11, 2009

Conditions

Stroke

Keywords

Follow-up after stroke

Outcome Measures

Primary Outcomes (1)

  • Total mortality

    3.5 years

Secondary Outcomes (1)

  • Recurrent stroke

    3.5 years

Study Arms (2)

Follow-up at an out-patient stroke unit

OTHER

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
Other: As the general practitioner wants to do

Interventions

Information, further rehabilitation, additional drugs to prevent recurrent strokeOTHER
Follow-up at an out-patient stroke unit
As the general practitioner wants to doOTHER
Follow-up with the general practitioner

Eligibility Criteria

AgeUp to 84 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • first stroke (ischemic or hemorrhagic)
  • age below 85 years
  • living at home before the stroke

You may not qualify if:

  • modified Rankin scale 5 points
  • other severe disease
  • expected survival less than one year
  • severe dementia
  • drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stroke unit, Department of Medicine, Lidkoeping hospital

Lidköping, SE-531 85, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

March 1, 2003

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 14, 2009

Record last verified: 2009-09

Locations

SE(1)