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Structured outpatient aftercare after stroke (SANO) - extended post-interventional follow-up

Organizational Data

DRKS-ID:
DRKS00033430
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2024-01-31
Last update in DRKS:
2024-03-15
Registration type:
Prospective

Acronym/abbreviation of the study

SANO-EXTEND

URL of the study

https://www.sano-studie.de/

Brief summary in lay language

General description: In Germany, around 260,000 people suffer a stroke every year, a number that will increase in the coming decades due to demographic trends. Worldwide, stroke is the second most common cause of death and the third most common cause of years lost to disability. With an almost nationwide network of stroke units and a dense network of rehabilitation clinics, acute care and rehabilitation treatment for stroke in Germany is of a high standard. However, there is a lack of structured and quality-assured follow-up care after discharge from acute inpatient or rehabilitation treatment to ensure the long-term success of treatment. Several studies have also shown that the proportion of patients with guideline-compliant risk factors after discharge from acute inpatient treatment is still unsatisfactory. Structured cross-sectoral aftercare programs are a possible strategy to exploit the full potential of secondary prevention in accordance with recommendations in current guidelines and to prevent recurrent strokes and other complications. SANO will be used to investigate the effectiveness of such a follow-up program.

Brief summary in scientific language

Scientific abstract: The primary research question is whether a structured cross-sectoral follow-up program (SNP) can significantly reduce the combined endpoint of incident recurrent stroke, myocardial infarction or death within five to six years after stroke compared to standard treatment. In addition, valid data will be collected on, among other things, the guideline-compliant adjustment of risk factors and the rate of hospital admissions and other complications.

Health condition or problem studied

ICD10:
I64 - Stroke, not specified as haemorrhage or infarction
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
In SANO EXTEND, subjects who were included in the intervention group in the main SANO study are asked about their general state of health, quality of life (PHQ8, GAD 7, FACIT-fatigue Scale, PROMIS-29, EQ-5D-5L) and risk factors by telephone or post five to six years after the first ischemic stroke. There is no intervention.
Arm 2:
In SANO EXTEND, subjects who were included in the control group in the main SANO study are asked about their general state of health, quality of life (PHQ8, GAD 7, FACIT-fatigue Scale, PROMIS-29, EQ-5D-5L) and risk factors by telephone or post five to six years after the first ischemic stroke. There is no intervention.

Endpoints

Primary outcome:
Combined endpoint of recurrent stroke, myocardial infarction or death within five to six years after stroke
Secondary outcome:
Rate of individual components of the primary endpoint Rate of transient ischemic attacks (TIAs) within five to six years after stroke Control of cardiovascular risk factors according to predefined targets based on clinical guidelines Functional outcome (mRS) after five to six years Drug treatment including prescription of antiplatelet or anticoagulant drugs Rate of readmission to hospital after five to six years Adequate provision of assistive devices and therapies Quality of life reported by patients (European Quality of Life 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS 29)) Rate of complications (cognitive impairment, depression and anxiety, fatigue, falls, etc.) and their guideline-compliant treatment

Study Design

Purpose:
Treatment
Retrospective/prospective:
Prospective
Study type:
Non-interventional
Longitudinal/cross-sectional:
Longitudinal study
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Institut für Klinische Epidemiologie und Biometrie (IKE-B) Würzburg

Recruitment period and number of participants

Planned study start date:
2024-06-01
Actual study start date:
No Entry
Planned study completion date:
2025-06-01
Actual Study Completion Date:
No Entry
Target Sample Size:
1654
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Patients who have participated in the SANO study and who have given their consent to the extended follow-up survey. Patient understands the contents of the study and can make the decision to participate in the study independently.

Exclusion Criteria

none

Addresses

Primary Sponsor

Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
Peter U. Heuschmann
Josef-Schneider-Str. 2 / Haus D7
97080 Würzbug
Germany
Telephone:
+49 (0)931 / 201 47308
Fax:
+49 (0)931 / 201 647
Contact per E-Mail
URL:
https://www.med.uni-wuerzburg.de/epidemiologie/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Neurologische Klinik Klinikum der Stadt Ludwigshafen a.Rh.
Dr. med. Christopher Schwarzbach
Bremserstr. 79
67063 Ludwigshafen
Germany
Telephone:
+4962150342674
Fax:
+496215034204
Contact per E-Mail
URL:
https://www.klilu.de/

Contact for Public Queries

Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
Lena Schmidbauer
Josef-Schneider-Str. 2 / Haus D7
97080 Würzburg
Germany
Telephone:
+49 931 201 47386
Fax:
+49 931 201 47386
Contact per E-Mail
URL:
https://www.med.uni-wuerzburg.de/epidemiologie/

Principal Investigator

Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
Prof. Dr. Peter U. Heuschmann
Josef-Schneider-Str. 2 / Haus D7
97080 Würzburg
Germany
Telephone:
+49 (0)931 / 201 47308
Fax:
+49 (0)931 / 647310
Contact per E-Mail
URL:
https://www.med.uni-wuerzburg.de/epidemiologie/

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsche Forschungsgemeinschaft (DFG)
Kennedyallee 40
53175 Bonn
Germany
Telephone:
+49 (228) 885-2297
Fax:
+49 (228) 885-713320
Contact per E-Mail
URL:
http://www.dfg.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
Josef-Schneider-Str. 4
97080 Würzburg
Germany
Telephone:
+49-931-3148315
Fax:
No Entry
Contact per E-Mail
URL:
http://www.med.uni-wuerzburg.de/ethik-kommission/startseite/

Vote of leading Ethics Committee

Date of ethics committee application:
2023-10-19
Ethics committee number:
156/23
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-10-24

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Providing of individual participant data (including metadata): yes The following data will be shared Individual, anonymized patient data Additional available documents Study protocol Duration in which the data is accessible (start and end date) 9 months to 36 months after publication of the article Providing the data for Scientists A dedicated Use and Access Committee appointed for this purpose must approve the scientists' project proposal Data transfer for the following types of analysis For meta-analyses based on the individual, anonymized patient data Providing the data through the following mechanism Project proposals can be submitted up to 36 months after the publication of an article. Inquiries and information regarding the submission of project proposals and data access are made via the corresponding author named on the main article (after publication of the main results)

Study protocol and other study documents

Study protocols:
SANO EXTEND Studienprotokoll
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry