Condition category
Infections and Infestations
Date applied
25/02/2011
Date assigned
19/04/2011
Last edited
04/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.allgemeinmedizin.uni-jena.de/content/research/smooth/index_eng.html

Contact information

Type

Scientific

Primary contact

Prof Jochen Gensichen

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01 E0 1002

Study information

Scientific title

Sepsis survivors monitoring and coordination in outpatient health care: a randomised, multicentre, prospective, two-armed intervention study

Acronym

Smooth

Study hypothesis

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

Local Ethics Committee of Jena University Hospital, approval No. 3001-01/11 - Pending

Study design

Randomised multicentre prospective two-armed intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Health-related quality of life
2. Physical Health Summary Scale (SF-36 – Patient survey) after 6 months

Secondary outcome measures

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)

Overall trial start date

28/02/2011

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

290

Participant exclusion criteria

1. Dementia (TICSM < 27)
2. Guardianship before sepsis
3. Nursing home residents
4. Severe language/speech disorder
5. Deaf or blind patients

Recruitment start date

28/02/2011

Recruitment end date

31/07/2015

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Jena
Jena
D-07743
Germany

Sponsor information

Organisation

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

Sponsor details

Friedrichstraße 130 B
Berlin
10117
Germany
+49 (0)30 1857 83601
information@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de/en/index.php

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung (Grant no. 01 E0 1002)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Funder name

Center of Sepsis Control & Care (CSCC) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25015838
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27367877

Publication citations

  1. Protocol

    Schmidt K, Thiel P, Mueller F, Schmuecker K, Worrack S, Mehlhorn J, Engel C, Brenk-Franz K, Kausche S, Jakobi U, Bindara-Klippel A, Schneider N, Freytag A, Davydow D, Wensing M, Brunkhorst FM, Gensichen J, , Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial., Trials, 2014, 15, 283, doi: 10.1186/1745-6215-15-283.

  2. Results

    Schmidt K, Worrack S, Von Korff M, Davydow D, Brunkhorst F, Ehlert U, Pausch C, Mehlhorn J, Schneider N, Scherag A, Freytag A, Reinhart K, Wensing M, Gensichen J; SMOOTH Study Group, Effect of a Primary Care Management Intervention on Mental Health-Related Quality of Life Among Survivors of Sepsis: A Randomized Clinical Trial, JAMA, 2016, 315, 24, 2703-2711, doi: 10.1001/jama.2016.7207.

Additional files

Editorial Notes

04/07/2016: Publication reference added.