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
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)|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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|
- 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.
- return to work [ Time Frame: 3 months, 6 months, 12 months after discharge from the ICU ]Assessment by questionnaire
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
|Contact: Thomas Bein, Prof. Dr.||++email@example.com|
|Contact: Christian Apfelbacher, PhDfirstname.lastname@example.org|
|Berlin, Germany, 10117|
|Contact: Steffen Weber-Carstens, PhD ++49-30-450651055 email@example.com|
|Contact: Anton Goldmann, Dr ++49-30-4500 firstname.lastname@example.org|
|Göttingen, Germany, 37075|
|Contact: Lars-Olav Harnisch, Dr. +49551/39-13328 email@example.com|
|Contact: Michael Quintel, Prof. Dr. +49551/39-13328 firstname.lastname@example.org|
|Klinik für Intensivmedizin||Recruiting|
|Hamburg, Germany, 20246|
|Contact: Stefan Kluge, Prof.Dr. 49-(0)40-7410-57010 email@example.com|
|Principal Investigator:||Thomas Bein, Prof. Dr.||University Hospital Regensburg, Germany|