Patient Satisfaction in Stroke Patients | NCT00994409

Studies
Patient Satisfaction in Stroke Patients

NCT00994409

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Dec 1, 2010Estimated

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Germany

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

ID	Type	Description	Link
EA4/019/08

Status Module

Record Verification Date

Nov 2010

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

Jul 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Oct 13, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 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

Nov 30, 2010

Last Update Posted Date

Dec 1, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Name	Class
Center for Stroke Research Berlin	OTHER
German Federal Ministry of Education and Research	OTHER_GOV

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

The objective of this trial is to guarantee a follow-up of all stroke and transient ischemic attack (TIA) patients. With this follow-up assessment long term effects of therapy and prevention measures can be detected and monitored. It is part of quality assurance.

Detailed Description

Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness Key secondary endpoint(s): Compliance/adherence with discharge medication. Re-events. Degree of Disability. Activities of daily living. Mortality.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness.		September 2010

Secondary Outcomes

Measure	Description	Time Frame
Compliance/adherence with discharge medication Activities of daily living		September 2010
Re-events		September 2010
Degree of Disability

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients eligible

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stroke and TIA patients treated at the Charite with acute stroke or TIA onset less than 7 days

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter U Heuschmann, Professor	Center for Stroke Research Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Neurology, Charité Campus Benjamin Franklin		Berlin			Germany

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