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Prognostication of Need for Rehabilitation and Special Support in ICU Survivors (PROGRESS-ICU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679157
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Peter Sackey, Karolinska Institutet

Brief Summary:

Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study

Objectives:

  1. To investigate associations between potential risk factors (premorbid factors, in-ICU treatments/diagnoses and patient status at ICU discharge) and three-month physical and psychological outcome in ICU survivors.
  2. Based on the associations between identified risk factors and adverse outcomes, create and validate instruments, to be used at ICU discharge, predicting new-onset physical or psychological problems three months after ICU discharge.

Study design:

Prospective, observational multi centre (10 centres) cohort studies

Outcomes:

Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress Syndrome-14 (PTSS-14) part B score >45 or Hospital Anxiety and Depression Scale (HADS) subscale score >10). New-onset physical disability, defined as a reduction in Barthel Index ≥10 points compared with 2 weeks prior to hospital admission.

Study duration:

Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary endpoints 3 months after ICU discharge.

Number of subjects:

The aim is to screen all eligible patients and include 600-1000 ICU survivors during the recruitment period. The final number of included patients depends on case-mix in the units and potential exclusions.

Population:

Adult patients (18 years or older) discharged from ICU.


Condition or disease
Physical Disability Depression Posttraumatic Stress Disorder Anxiety

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 573 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostication of Need for Rehabilitation and Special Support in ICU Survivors. Two Studies Prognosticating Adverse Physical or Psychological Outcome
Actual Study Start Date : January 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. Adverse psychological outcome [ Time Frame: Three months post-ICU ]
    Caseness defined as PTSS-14 part B score above 45 or HADS subscale score above 10

  2. Adverse physical outcome [ Time Frame: Three months post-ICU ]
    Caseness defined as Reduction in Barthel Index (0-100) by 10 points or more


Secondary Outcome Measures :
  1. Health-related quality of life assessed with Short Form -36 in patients [ Time Frame: In first three months post-ICU ]
    Health-related quality of Life domains in relation to adverse outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult ICU patients
Criteria

Inclusion Criteria:

ICU stay>24 hours for postoperative patients and >12 hours for other ICU admissions

Exclusion Criteria:

  1. Previously documented cognitive impairment (e.g. dementia or intellectual development disorder resulting in poor understanding/compliance in outcome assessment)
  2. No home address
  3. Unable to read and write in language spoken at local study site (Swedish/Danish/Dutch)/used in questionnaires
  4. Patient declines participation
  5. Moribund patient or with more than one limitation of therapy
  6. Need for neurointensive care due to head trauma, intracranial hemorrhage or infarction AND GCS never better than 13 in the first 48 hours
  7. Transfer to other ICU before discharge to ward
  8. Solely in ICU for elective procedure (eg central line, epidural)

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): NCT02679157


Locations
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Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Netherlands
University Medical Centre Radboud
Nijmegen, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands
Sweden
Östersund Hospital
Östersund, Jämtland, Sweden
Umeå University Hospital
Umeå, Västerbotten, Sweden
Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
Stockholm, Sweden, 171 76
Stockholm South Hospital
Stockholm, Sweden
Dept of Anesthesia and Intensive Care, Uppsala Akademiska
Uppsala, Sweden
Örebro University Hospital
Örebro, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Stockholm County Council, Sweden
Investigators
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Study Chair: Peter V Sackey, MD, PhD Karolinska University Hospital
Principal Investigator: Anna Milton, MD Karolinska University Hospital
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Sackey, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02679157    
Other Study ID Numbers: EPN 2015/1799-31
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter Sackey, Karolinska Institutet:
Posttraumatic stress disorder
Depression
Anxiety
ADL
Health-related quality of life
ICU survivorship
Additional relevant MeSH terms:
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Depression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders