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

NCT02637011 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2015-12-22

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome (ARDS)

Sponsors & Collaborators

  • University of Regensburg

    collaborator OTHER

  • University Hospital Regensburg

    lead OTHER

Principal Investigators

  • Thomas Bein, Prof. Dr. · University Hospital Regensburg, Germany

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-05-31
Completion
2017-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637011 on ClinicalTrials.gov