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Surviving ARDS: The Influence of Quality of Care and Individual Patient Characteristics on Quality of Life (DACAPO)

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ClinicalTrials.gov Identifier: NCT02637011
Recruitment Status : Unknown
Verified December 2015 by Prof. Dr. Thomas Bein M.A., University Hospital Regensburg.
Recruitment status was:  Recruiting
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Collaborator:
University of Regensburg
Information provided by (Responsible Party):
Prof. Dr. Thomas Bein M.A., University Hospital Regensburg

Brief Summary:

The purpose of the DACAPO study ("Surviving ARDS: the influence of quality of care and individual patient characteristics on quality of life") is to investigate the role of quality of care and individual patient characteristics on quality of life and return to work in survivors of ARDS (acute respiratory distress syndrome). It is hypothesized that higher quality of care is associated with better health-related quality of life and a higher rate of return to work among survivors.

A prospective, observational, multi-centre patient cohort study is performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyze a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. Quality of care will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (health related quality of life and return to work) will be gathered by self-report questionnaires. Further data assessment includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of quality of care and individual patient characteristics on outcomes, taking the cluster structure of the data into account.


Condition or disease
Acute Respiratory Distress Syndrome (ARDS)

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Quality of Care and Individual Patient Characteristics on Quality of Life/ Return to Work in Survivors of the Acute Respiratory Distress Syndrome (ARDS): Prospective, Observational, Multi-centre Cohort Study
Study Start Date : September 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2017





Primary Outcome Measures :
  1. Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12) [ Time Frame: 3 months, 6 months, 12 months after discharge from the ICU ]
    change from baseline (discharge from the ICU) to 3 months, 6 months and 12 months, respectively.


Secondary Outcome Measures :
  1. return to work [ Time Frame: 3 months, 6 months, 12 months after discharge from the ICU ]
    Assessment by questionnaire



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study participants will be selected of patients with ARDS treated at intensive care units of the participating hospitals. Participating hospitals are members of the ARDS Network Germany or other hospitals which agreed to take part in the study.
Criteria

Inclusion Criteria:

  • ARDS according to the criteria of the Berlin-Definition:

    i) Acute onset within one week, ii) bilateral pulmonary infiltrates (chest imaging), iii) respiratory failure not fully explained by cardiac failure or fluid overload.

  • informed consent provided by the patient or the legal guardian
  • 18 years old or older

Exclusion Criteria:

  • no ARDS
  • no informed consent provided by the patient or the legal guardian
  • younger than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637011


Contacts
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Contact: Thomas Bein, Prof. Dr. ++49-941-944-0 thomas.bein@ukr.de
Contact: Christian Apfelbacher, PhD ++49-941-944-0 christian.apfelbacher@ukr.de

Locations
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Germany
Universitätsmedizin Charite Recruiting
Berlin, Germany, 10117
Contact: Steffen Weber-Carstens, PhD    ++49-30-450651055    steffen.weber-carstens@charite.de   
Contact: Anton Goldmann, Dr    ++49-30-4500    anton.goldmann@charite.de   
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Lars-Olav Harnisch, Dr.    +49551/39-13328    lars-olav.harnisch@med.uni-goettingen.de   
Contact: Michael Quintel, Prof. Dr.    +49551/39-13328    mquintel@med.uni-goettingen.de   
Klinik für Intensivmedizin Recruiting
Hamburg, Germany, 20246
Contact: Stefan Kluge, Prof.Dr.    49-(0)40-7410-57010    s.kluge@uke.de   
Sponsors and Collaborators
University Hospital Regensburg
University of Regensburg
Investigators
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Principal Investigator: Thomas Bein, Prof. Dr. University Hospital Regensburg, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. Thomas Bein M.A., Principal Investigator, University Hospital Regensburg
ClinicalTrials.gov Identifier: NCT02637011    
Other Study ID Numbers: 01GY1340
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Prof. Dr. Thomas Bein M.A., University Hospital Regensburg:
acute respiratory distress syndrome
intensive care medicine
critical illness
long-term outcomes
quality of life
return to work
quality of care
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury