Follow-up Pilot Study After a First Stroke | NCT00976001

Studies
Follow-up Pilot Study After a First Stroke

NCT00976001

Sponsor

Skaraborg Hospital

Status

Completed

Last Update Posted

Sep 14, 2009Estimated

Enrollment

163Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

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

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Sep 11, 2009

First Submission Date that Met QC Criteria

Sep 11, 2009

First Posted Date

Sep 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2009

Last Update Posted Date

Sep 14, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

163Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Information, further rehabilitation, additional drugs to prevent recurrent stroke	Other		Follow-up at an out-patient stroke unit

Measure	Description	Time Frame
Total mortality		3.5 years

Measure	Description	Time Frame
Recurrent stroke		3.5 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

84 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stroke unit, Department of Medicine, Lidkoeping hospital		Lidköping		SE-531 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided