Turn sepsis to life!

ISRCTN	ISRCTN61744782
DOI	https://doi.org/10.1186/ISRCTN61744782
Protocol serial number	01 E0 1002
Sponsor	German Federal Ministry of Education and Research (BMBF) (Germany)
Funders	Bundesministerium für Bildung und Forschung (Grant no. 01 E0 1002), Center of Sepsis Control & Care (CSCC) (Germany)

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 of protocol

Not provided at time of registration

Contact information

Prof Jochen Gensichen
Scientific

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

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

Study information

Primary study design	Interventional
Study design	Randomised multicentre prospective two-armed intervention study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Sepsis survivors monitoring and coordination in outpatient health care: a randomised, multicentre, prospective, two-armed intervention study
Study acronym	Smooth
Study objectives	Health-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
Health condition(s) or problem(s) studied	Severe sepsis or septic shock
Intervention	Patients 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 type	Other
Primary outcome measure(s)	1. Health-related quality of life 2. Physical Health Summary Scale (SF-36 Patient survey) after 6 months
Key secondary outcome measure(s)	1. 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)
Completion date	31/07/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	290
Key inclusion criteria	1. 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
Key exclusion criteria	1. Dementia (TICSM < 27) 2. Guardianship before sepsis 3. Nursing home residents 4. Severe language/speech disorder 5. Deaf or blind patients
Date of first enrolment	28/02/2011
Date of final enrolment	31/07/2015

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Jena

Jena
D-07743
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/06/2016		Yes	No
Protocol article	protocol	11/07/2014		Yes	No
Other publications	post hoc analysis of depressive symptoms	29/04/2021	05/05/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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