Turn sepsis to life!

ISRCTN ISRCTN61744782
DOI https://doi.org/10.1186/ISRCTN61744782
Secondary identifying numbers 01 E0 1002
Submission date
25/02/2011
Registration date
19/04/2011
Last edited
05/05/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof Jochen Gensichen
Scientific

Department of General Practice and Family Medicine
University Hospital Jena
Bachstr. 18
Jena
D-07743
Germany

+49 (0)3641 939 5800
jochen.gensichen@med.uni-jena.de

Study information

Study designRandomised multicentre prospective two-armed intervention study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSepsis survivors monitoring and coordination in outpatient health care: a randomised, multicentre, prospective, two-armed intervention study
Study acronymSmooth
Study hypothesisHealth-related quality of life of survivors of severe sepsis or septic shock can be improved significantly after six months by application of a specific Disease Management Program
Ethics approval(s)Local Ethics Committee of Jena University Hospital, approval No. 3001-01/11 - Pending
ConditionSevere sepsis or septic shock
InterventionPatients of the intervention group will receive for 12 months in total a specific Disease Management Program, consisting of discharge management, patient monitoring for main sepsis complications and education of patients and treating family physicians in sepsis sequelae.
Intervention typeOther
Primary outcome measure1. Health-related quality of life
2. Physical Health Summary Scale (SF-36 – Patient survey) after 6 months
Secondary outcome measures1. Health-related quality of life
2. Physical Health Summary Scale (SF-36 – Patient survey) after 12 and 24 months
3. Physical activity (XSMFA-D - Patient survey)
4. Patient adherence (Moriskey – Patient survey)
5. Process of care (PACIC (Patient Assessment of Care for Chronic Conditions - patient survey)
6. Death for any reason
7. Number of readmissions for any reason
8. Number of hospital days for any reason (GP/post-sepsis-center documentation)
9. Numbers of contacts to GP (GP documentation)
10. Numbers of contacts to specialists (GP documentation)
11. Days on which patient is unfit to work (GP documentation)
12. Medication (PZN and modus – Patient survey/GP/post-sepsis-center documentation)
13. Cognitive function (TICS-M (Telephone Interview of Cognitive Status) (Patient survey)
14. Nutritional status (MUST (Malnutrition Universal Screening Tool GP documentation (Patient survey)
15. Chronic pain (GCPS (Graded Chronic Pain Scale) (Patient survey)
16. Neuropathic symptoms (NSS (Neuropathie-Symptom Score) (Patient survey)
17. Post traumatic stress syndrom symptoms (PTSS-10 (Post-Traumatic Stress Syndrome, 10 Questions Inventory (Patient survey)
18. Depressive symptoms (MDI (Major Depression Inventory) (Patient survey)
19. Body perception (DKB (Dresdner Körperfragenbogen) (Patient survey)
20. Attachment pattern (ECR-S (Experiences in Close Relationsship Scale Short form)
21. Insomnia symptoms (RIS (Regensburger Insomniebogen) (Patient survey)
22. ADL (instrumental) activities of daily life (Patient survey)
23. Smelling, hearing, degustation dysfunction (Patient survey)
24. Medication use (KFM (Kurzfragebogen zum Medikamentengebrauch) Patient survey)
Overall study start date28/02/2011
Overall study end date31/07/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants290
Participant inclusion criteria1. Survivors of severe sepsis or septic shock (ICD-10: A41)
2. At least two systemic inflammatory response syndrome (SIRS) criteria
3. At least one organ dysfunction
4. Adults
5. Sufficient German language skills
6. Patients have primary care provider
Participant exclusion criteria1. Dementia (TICSM < 27)
2. Guardianship before sepsis
3. Nursing home residents
4. Severe language/speech disorder
5. Deaf or blind patients
Recruitment start date28/02/2011
Recruitment end date31/07/2015

Locations

Countries of recruitment

  • Germany

Study participating centre

University Hospital Jena
Jena
D-07743
Germany

Sponsor information

German Federal Ministry of Education and Research (BMBF) (Germany)
Government

Friedrichstraße 130 B
Berlin
10117
Germany

+49 (0)30 1857 83601
information@bmbf.bund.de
http://www.bmbf.de/en/index.php
ROR logo https://ror.org/04pz7b180

Funders

Funder type

Government

Bundesministerium für Bildung und Forschung (Grant no. 01 E0 1002)
Government organisation / National government
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Location
Germany
Center of Sepsis Control & Care (CSCC) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/07/2014 Yes No
Results article results 28/06/2016 Yes No
Other publications post hoc analysis of depressive symptoms 29/04/2021 05/05/2021 Yes No

Editorial Notes

05/05/2021: Publication reference added.
04/07/2016: Publication reference added.

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