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

NCT02637011 | Unknown

• 1 other identifier: 01GY1340
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

acute respiratory distress syndrome; intensive care medicine; critical illness; long-term outcomes; quality of life; return to work; quality of care

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life, measured by the Short-Form 12-item Health-Survey (SF-12)

  change from baseline (discharge from the ICU) to 3 months, 6 months and 12 months, respectively.

  3 months, 6 months, 12 months after discharge from the ICU

Secondary Outcomes (1)

• return to work

  3 months, 6 months, 12 months after discharge from the ICU

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years old or older

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Regensburg: lead
• University of Regensburg: collaborator

Study Sites (3)

Universitätsmedizin Charite

Berlin, State of Berlin, 10117, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Klinik für Intensivmedizin

Hamburg, 20246, Germany

RECRUITING

Related Publications (6)

• Blecha S, Zeman F, Rohr M, Dodoo-Schittko F, Brandstetter S, Karagiannidis C, Apfelbacher C, Bein T; DACAPO study group. Association of analgosedation with psychiatric symptoms and health-related quality of life in ARDS survivors: Post hoc analyses of the DACAPO study. PLoS One. 2022 Oct 21;17(10):e0275743. doi: 10.1371/journal.pone.0275743. eCollection 2022.

  PMID: 36269731 DERIVED

• Apfelbacher C, Brandstetter S, Blecha S, Dodoo-Schittko F, Brandl M, Karagiannidis C, Quintel M, Kluge S, Putensen C, Bercker S, Ellger B, Kirschning T, Arndt C, Meybohm P, Weber-Carstens S; DACAPO study group; Bein T. Influence of quality of intensive care on quality of life/return to work in survivors of the acute respiratory distress syndrome: prospective observational patient cohort study (DACAPO). BMC Public Health. 2020 Jun 5;20(1):861. doi: 10.1186/s12889-020-08943-8.

  PMID: 32503583 DERIVED

• Blecha S, Brandl M, Zeman F, Dodoo-Schittko F, Brandstetter S, Karagiannidis C, Bein T, Apfelbacher C; DACAPO Study Group. Tracheostomy in patients with acute respiratory distress syndrome is not related to quality of life, symptoms of psychiatric disorders or return-to-work: the prospective DACAPO cohort study. Ann Intensive Care. 2020 May 6;10(1):52. doi: 10.1186/s13613-020-00671-x.

  PMID: 32377963 DERIVED

• Blecha S, Brandstetter S, Dodoo-Schittko F, Brandl M, Graf BM, Bein T, Apfelbacher C. Acceptability of a German multicentre healthcare research study: a survey of research personnels' attitudes, experiences and work load. BMJ Open. 2018 Sep 24;8(9):e023166. doi: 10.1136/bmjopen-2018-023166.

  PMID: 30249633 DERIVED

• Dodoo-Schittko F, Brandstetter S, Brandl M, Blecha S, Quintel M, Weber-Carstens S, Kluge S, Kirschning T, Muders T, Bercker S, Ellger B, Arndt C, Meybohm P, Adamzik M, Goldmann A, Karagiannidis C, Bein T, Apfelbacher C; DACAPO Study Group. German-wide prospective DACAPO cohort of survivors of the acute respiratory distress syndrome (ARDS): a cohort profile. BMJ Open. 2018 Apr 4;8(4):e019342. doi: 10.1136/bmjopen-2017-019342.

  PMID: 29622574 DERIVED

• Blecha S, Dodoo-Schittko F, Brandstetter S, Brandl M, Dittmar M, Graf BM, Karagiannidis C, Apfelbacher C, Bein T; DACAPO Study Group. Quality of inter-hospital transportation in 431 transport survivor patients suffering from acute respiratory distress syndrome referred to specialist centers. Ann Intensive Care. 2018 Jan 15;8(1):5. doi: 10.1186/s13613-018-0357-y.

  PMID: 29335831 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Bein, Prof. Dr.

  University Hospital Regensburg, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Bein, Prof. Dr.

CONTACT

++49-941-944-0; thomas.bein@ukr.de

Christian Apfelbacher, PhD

CONTACT

++49-941-944-0; christian.apfelbacher@ukr.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 22, 2015
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: December 22, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)