StrokePatZuFrieNCT00994409
Patient Satisfaction in Stroke Patients
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,200 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke and TIA patients treated at the Charite with acute stroke or TIA onset less than 7 days
Who may be able to join
- all patients eligible
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Berliner Schlaganfallregister - Nachbefragung Von Patienten Mit Schlaganfall
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness.
Measured: September 2010
Secondary outcomes (4)
Compliance/adherence with discharge medication Activities of daily living
Measured: September 2010
Re-events
Measured: September 2010
Degree of Disability
Measured: September 2010
Mortality
Measured: September 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Stroke Research Berlin, German Federal Ministry of Education and Research
- Investigators
- Peter U Heuschmann, Professor, Principal investigator, Center for Stroke Research Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994409
- Sponsor's protocol ID
- CSB-PatZuFrie
- Other IDs
- EA4/019/08
- Acronym
- PatZuFrie
- Status last verified
- Nov 2010
- First submitted
- 13 Oct 2009
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berliner Schlaganfallregister - Nachbefragung Von Patienten Mit Schlaganfall
- ClinicalTrials.gov ID
- NCT00994409
- Acronym / sponsor ID
- PatZuFrie / CSB-PatZuFrie
- Conditions
- Stroke
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Center for Stroke Research Berlin, German Federal Ministry of Education and Research
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke and TIA patients treated at the Charite with acute stroke or TIA onset less than 7 days
Key inclusion criteria (1 listed)
- all patients eligible
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness.
Time frame: September 2010
4 secondary outcomes
Compliance/adherence with discharge medication Activities of daily living
Time frame: September 2010
Re-events
Time frame: September 2010
Degree of Disability
Time frame: September 2010
Mortality
Time frame: September 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter U Heuschmann, Professor principal investigator
Center for Stroke Research Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint: Number of patients who state that they received all the information they want about the causes and nature of their illness. (time frame: September 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.