Physical DisabilityPROGRESS-ICUNCT02679157
Prognostication of Need for Rehabilitation and Special Support in ICU Survivors
An observational study of Physical Disability and Depression, run by Karolinska University Hospital at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Disability, Depression, Posttraumatic Stress Disorder
- How many people
- 573 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients
Who may be able to join
- ICU stay>24 hours for postoperative patients and >12 hours for other ICU admissions
Who cannot join
- Previously documented cognitive impairment (e.g. dementia or intellectual development disorder resulting in poor understanding/compliance in outcome assessment)
- No home address
- Unable to read and write in language spoken at local study site (Swedish/Danish/Dutch)/used in questionnaires
- Patient declines participation
- Moribund patient or with more than one limitation of therapy
- Need for neurointensive care due to head trauma, intracranial hemorrhage or infarction AND GCS never better than 13 in the first 48 hours
- Transfer to other ICU before discharge to ward
- Solely in ICU for elective procedure (eg central line, epidural)
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Sweden6 sites
Örebro University Hospital
Örebro
Östersund Hospital
Östersund, Jämtland County
Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
Stockholm, 171 76
Stockholm South Hospital
Stockholm
Umeå University Hospital
Umeå, Västerbotten County
Dept of Anesthesia and Intensive Care, Uppsala Akademiska
Uppsala
Denmark2 sites
Rigshospitalet Copenhagen
Copenhagen
Odense University Hospital
Odense
Netherlands2 sites
University Medical Centre Radboud
Nijmegen
University Medical Centre Utrecht
Utrecht
About this study
Official title: Prognostication of Need for Rehabilitation and Special Support in ICU Survivors. Two Studies Prognosticating Adverse Physical or Psychological Outcome
Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study
Objectives:
Read more
- 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.
- 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.
Read the detailed description
Every year, an estimated 5 million patients are treated in European Intensive Care Units (ICUs) yearly, with 40 000 in Swedish ICUs alone (1,2). As many as 50 % of ICU survivors suffer from new-onset physical, psychological or cognitive problems in the months or even years after ICU discharge, irrespective of the reason for ICU admission (3-5). These problems are major hurdles for patients discharged from the ICU to return to life as it was prior to hospitalisation, but often remain unrecognised by healthcare providers (3-5). Follow-up led by ICU clinicians is increasingly recognised as an addendum to critical care (5,6). Yet, interventions in large and unselected groups of ICU survivors have failed to demonstrate meaningful improvements (7,8) except in vulnerable subgroups (9,10). Dilution of treatment effects is a recognised problem in interventional studies (11). Thus, identifying patients with risk for adverse outcome is an important enrichment step prior to evaluation of new interventions. The importance has recently been highlighted at a stakeholders meeting regarding post-ICU syndrome (12). Pilot studies from our research group indicate that risk prediction instruments for ICU survivors with fairly good accuracy can be developed and used in clinical practice (13,14) but predictors need to be assessed and validated in a larger sample.
Data collection All data will be entered in coded form to a web-based, electronic Case Report Form (Pheedit eCRF) supplied by the Central Steering Committee. The eCRF will be accessible with a username and password at all computers with internet access. All data can be entered in the eCRF. Each centre will keep a safely placed and locked patient ID and study code list, separate from the study data.
Potential risk factors:
Patient characteristics Age Sex Educational level Working/school/parental leave/retired/unemployed/sick-leave Physical comorbidities (Charlson Comorbidity Index \& SAPS III box 1) (supplement) History of psychological problems before ICU stay, including substance abuse) Caretaker of a child <18 years old** Barthel Index-100 prior to falling ill, reported by patient, and/or proxy together with medical chart review
In-ICU diagnoses/treatments/status Admission diagnosis (medical/surgical/trauma) Acute/elective hospital admission Admission severity of illness (APACHE II) Pelvic fracture Fractures (other than pelvic) ICU length of stay (hours) Severe sepsis/septic chock* Days with coma (for any reason) Days with invasive ventilator treatment Agitation/agitated delirium during ICU stay**
Patient status at ICU discharge Depressive symptoms with PHQ2 questions (two questions, supplement) Chelsea Critical Care Physical Assessment Tool (CPAx) Questions 1-5 (supplement) within 24 hours prior to discharge* PTSS-14 Part A (four questions, supplement) Social support (one question, supplement)
Three months post-ICU discharge Hospital Anxiety and Depression Scale (HADS) (supplement) Posttraumatic Stress Symptoms 14 (PTSS-14) (supplement) Barthel Index (supplement) Short Form 36 Health Survey (supplement) Health utilization questionnaire
Questionnaires will be sent by postal mail to all patients, together with an information letter about participation in the studies and a consent form to sign for those unable to give consent at inclusion. A phone number will be supplied, for patients with questions or who wish to know more regarding their ICU stay. Ten-fourteen days after questionnaires have been sent out, a reminder telephone call will be made to patients who have not returned the questionnaires.
Consent Patients will be asked for consent at study inclusion. If unable to consent, patients will be asked for consent at three months post ICU, when questionnaires are being sent out.
Inter-rater reliability Risk factors that are assessed by observation, where no validated instruments are available, will undergo interrater reliability testing within the study. Ten patients per centre will be assessed in parallel by two independent observers, blinded to each other´s assessment. Specifically, the factors are the items of CPAx.
Outcome measures:
Two primary outcome measures:
- Adverse psychological outcome at three months post-ICU discharge is defined as a subscale score >10 in the Hospital Anxiety and Depression Scale (HADS), indicative of clinically significant depressive or anxiety symptoms, AND/OR a Posttraumatic Stress Symptoms -14 (PTSS-14) part B score >45 indicative of clinically significant posttraumatic stress symptoms.
- Adverse physical outcome (new-onset physical disability) three months post-ICU discharge is defined as a worsening of the Barthel Index-100 by 10 points or more, compared to the reported Barthel Index-100 two weeks prior to hospitalisation.
- Keywords
- Posttraumatic stress disorder, Depression, Anxiety, ADL, Health-related quality of life, ICU survivorship
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse psychological outcome
Caseness defined as PTSS-14 part B score above 45 or HADS subscale score above 10
Measured: Three months post-ICU
Adverse physical outcome
Caseness defined as Reduction in Barthel Index (0-100) by 10 points or more
Measured: Three months post-ICU
Secondary outcomes (1)
Health-related quality of life assessed with Short Form -36 in patients
Health-related quality of Life domains in relation to adverse outcomes
Measured: In first three months post-ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Peter Sackey, Karolinska Institutet
- Investigators
- Peter V Sackey, MD, PhD, Study chair, Karolinska University HospitalAnna Milton, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679157
- Sponsor's protocol ID
- EPN 2015/1799-31
- Acronym
- PROGRESS-ICU
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rhodes A, Ferdinande P, Flaatten H, Guidet B, Metnitz PG, Moreno RP. The variability of critical care bed numbers in Europe. Intensive Care Med. 2012 Oct;38(10):1647-53. doi: 10.1007/s00134-012-2627-8. Epub 2012 Jul 10.
PubMed 22777516Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
PubMed 21946660Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5.
PubMed 20959786Modrykamien AM. The ICU follow-up clinic: a new paradigm for intensivists. Respir Care. 2012 May;57(5):764-72. doi: 10.4187/respcare.01461. Epub 2011 Dec 8.
PubMed 22152275Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A, Hull A, Breeman S, Norrie J, Jenkinson D, Hernandez R, Johnston M, Wilson E, Waldmann C; PRaCTICaL study group. The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ. 2009 Oct 16;339:b3723. doi: 10.1136/bmj.b3723.
PubMed 19837741Jones C, Skirrow P, Griffiths RD, Humphris GH, Ingleby S, Eddleston J, Waldmann C, Gager M. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003 Oct;31(10):2456-61. doi: 10.1097/01.CCM.0000089938.56725.33.
PubMed 14530751Schandl A, Bottai M, Hellgren E, Sundin O, Sackey P. Gender differences in psychological morbidity and treatment in intensive care survivors--a cohort study. Crit Care. 2012 May 14;16(3):R80. doi: 10.1186/cc11338.
PubMed 22578016Schandl A, Bottai M, Hellgren E, Sundin O, Sackey PV. Developing an early screening instrument for predicting psychological morbidity after critical illness. Crit Care. 2013 Sep 24;17(5):R210. doi: 10.1186/cc13018.
PubMed 24063256Schandl A, Bottai M, Holdar U, Hellgren E, Sackey P. Early prediction of new-onset physical disability after intensive care unit stay: a preliminary instrument. Crit Care. 2014 Jul 31;18(4):455. doi: 10.1186/s13054-014-0455-7.
PubMed 25079385Sackett DL. Why randomized controlled trials fail but needn't: 2. Failure to employ physiological statistics, or the only formula a clinician-trialist is ever likely to need (or understand!). CMAJ. 2001 Oct 30;165(9):1226-37. No abstract available.
PubMed 11706914Milton A, Schandl A, Soliman IW, Meijers K, van den Boogaard M, Larsson IM, Brorsson C, Ostberg U, Oxenboll-Collet M, Savilampi J, Paskins S, Bottai M, Sackey PV. Development of an ICU discharge instrument predicting psychological morbidity: a multinational study. Intensive Care Med. 2018 Dec;44(12):2038-2047. doi: 10.1007/s00134-018-5467-3. Epub 2018 Nov 22.
PubMed 30467678
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostication of Need for Rehabilitation and Special Support in ICU Survivors. Two Studies Prognosticating Adverse Physical or Psychological Outcome
- ClinicalTrials.gov ID
- NCT02679157
- Acronym / sponsor ID
- PROGRESS-ICU / EPN 2015/1799-31
- Keywords
- Posttraumatic stress disorder, Depression, Anxiety, ADL, Health-related quality of life, ICU survivorship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jan 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study
Objectives:
- 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.
- 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.
Detailed description
Every year, an estimated 5 million patients are treated in European Intensive Care Units (ICUs) yearly, with 40 000 in Swedish ICUs alone (1,2). As many as 50 % of ICU survivors suffer from new-onset physical, psychological or cognitive problems in the months or even years after ICU discharge, irrespective of the reason for ICU admission (3-5). These problems are major hurdles for patients discharged from the ICU to return to life as it was prior to hospitalisation, but often remain unrecognised by healthcare providers (3-5). Follow-up led by ICU clinicians is increasingly recognised as an addendum to critical care (5,6). Yet, interventions in large and unselected groups of ICU survivors have failed to demonstrate meaningful improvements (7,8) except in vulnerable subgroups (9,10). Dilution of treatment effects is a recognised problem in interventional studies (11). Thus, identifying patients with risk for adverse outcome is an important enrichment step prior to evaluation of new interventions. The importance has recently been highlighted at a stakeholders meeting regarding post-ICU syndrome (12). Pilot studies from our research group indicate that risk prediction instruments for ICU survivors with fairly good accuracy can be developed and used in clinical practice (13,14) but predictors need to be assessed and validated in a larger sample.
Data collection All data will be entered in coded form to a web-based, electronic Case Report Form (Pheedit eCRF) supplied by the Central Steering Committee. The eCRF will be accessible with a username and password at all computers with internet access. All data can be entered in the eCRF. Each centre will keep a safely placed and locked patient ID and study code list, separate from the study data.
Potential risk factors:
Patient characteristics Age Sex Educational level Working/school/parental leave/retired/unemployed/sick-leave Physical comorbidities (Charlson Comorbidity Index \& SAPS III box 1) (supplement) History of psychological problems before ICU stay, including substance abuse) Caretaker of a child <18 years old** Barthel Index-100 prior to falling ill, reported by patient, and/or proxy together with medical chart review
In-ICU diagnoses/treatments/status Admission diagnosis (medical/surgical/trauma) Acute/elective hospital admission Admission severity of illness (APACHE II) Pelvic fracture Fractures (other than pelvic) ICU length of stay (hours) Severe sepsis/septic chock* Days with coma (for any reason) Days with invasive ventilator treatment Agitation/agitated delirium during ICU stay**
Patient status at ICU discharge Depressive symptoms with PHQ2 questions (two questions, supplement) Chelsea Critical Care Physical Assessment Tool (CPAx) Questions 1-5 (supplement) within 24 hours prior to discharge* PTSS-14 Part A (four questions, supplement) Social support (one question, supplement)
Three months post-ICU discharge Hospital Anxiety and Depression Scale (HADS) (supplement) Posttraumatic Stress Symptoms 14 (PTSS-14) (supplement) Barthel Index (supplement) Short Form 36 Health Survey (supplement) Health utilization questionnaire
Questionnaires will be sent by postal mail to all patients, together with an information letter about participation in the studies and a consent form to sign for those unable to give consent at inclusion. A phone number will be supplied, for patients with questions or who wish to know more regarding their ICU stay. Ten-fourteen days after questionnaires have been sent out, a reminder telephone call will be made to patients who have not returned the questionnaires.
Consent Patients will be asked for consent at study inclusion. If unable to consent, patients will be asked for consent at three months post ICU, when questionnaires are being sent out.
Inter-rater reliability Risk factors that are assessed by observation, where no validated instruments are available, will undergo interrater reliability testing within the study. Ten patients per centre will be assessed in parallel by two independent observers, blinded to each other´s assessment. Specifically, the factors are the items of CPAx.
Outcome measures:
Two primary outcome measures:
- Adverse psychological outcome at three months post-ICU discharge is defined as a subscale score >10 in the Hospital Anxiety and Depression Scale (HADS), indicative of clinically significant depressive or anxiety symptoms, AND/OR a Posttraumatic Stress Symptoms -14 (PTSS-14) part B score >45 indicative of clinically significant posttraumatic stress symptoms.
- Adverse physical outcome (new-onset physical disability) three months post-ICU discharge is defined as a worsening of the Barthel Index-100 by 10 points or more, compared to the reported Barthel Index-100 two weeks prior to hospitalisation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients
Key inclusion criteria (1 listed)
- ICU stay>24 hours for postoperative patients and >12 hours for other ICU admissions
Key exclusion criteria (8 listed)
- Previously documented cognitive impairment (e.g. dementia or intellectual development disorder resulting in poor understanding/compliance in outcome assessment)
- No home address
- Unable to read and write in language spoken at local study site (Swedish/Danish/Dutch)/used in questionnaires
- Patient declines participation
- Moribund patient or with more than one limitation of therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Adverse physical outcome
Time frame: Three months post-ICU
Caseness defined as Reduction in Barthel Index (0-100) by 10 points or more
1 secondary outcome
Health-related quality of life assessed with Short Form -36 in patients
Time frame: In first three months post-ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Background: PubMed 22777516Rhodes A, Ferdinande P, Flaatten H, Guidet B, Metnitz PG, Moreno RP. The variability of critical care bed numbers in Europe. Intensive Care Med. 2012 Oct;38(10):1647-53. doi: 10.1007/s00134-012-2627-8. Epub 2012 Jul 10.
- Background: PubMed 21946660Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
- Background: PubMed 20959786Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011 Feb;39(2):371-9. doi: 10.1097/CCM.0b013e3181fd66e5.
- Background: PubMed 22152275Modrykamien AM. The ICU follow-up clinic: a new paradigm for intensivists. Respir Care. 2012 May;57(5):764-72. doi: 10.4187/respcare.01461. Epub 2011 Dec 8.
- Background: PubMed 19837741Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A, Hull A, Breeman S, Norrie J, Jenkinson D, Hernandez R, Johnston M, Wilson E, Waldmann C; PRaCTICaL study group. The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ. 2009 Oct 16;339:b3723. doi: 10.1136/bmj.b3723.
- Background: PubMed 14530751Jones C, Skirrow P, Griffiths RD, Humphris GH, Ingleby S, Eddleston J, Waldmann C, Gager M. Rehabilitation after critical illness: a randomized, controlled trial. Crit Care Med. 2003 Oct;31(10):2456-61. doi: 10.1097/01.CCM.0000089938.56725.33.
- Background: PubMed 22578016Schandl A, Bottai M, Hellgren E, Sundin O, Sackey P. Gender differences in psychological morbidity and treatment in intensive care survivors--a cohort study. Crit Care. 2012 May 14;16(3):R80. doi: 10.1186/cc11338.
- Background: PubMed 24063256Schandl A, Bottai M, Hellgren E, Sundin O, Sackey PV. Developing an early screening instrument for predicting psychological morbidity after critical illness. Crit Care. 2013 Sep 24;17(5):R210. doi: 10.1186/cc13018.
- Background: PubMed 25079385Schandl A, Bottai M, Holdar U, Hellgren E, Sackey P. Early prediction of new-onset physical disability after intensive care unit stay: a preliminary instrument. Crit Care. 2014 Jul 31;18(4):455. doi: 10.1186/s13054-014-0455-7.
- Background: PubMed 11706914Sackett DL. Why randomized controlled trials fail but needn't: 2. Failure to employ physiological statistics, or the only formula a clinician-trialist is ever likely to need (or understand!). CMAJ. 2001 Oct 30;165(9):1226-37. No abstract available.
- Derived from this study: PubMed 30467678Milton A, Schandl A, Soliman IW, Meijers K, van den Boogaard M, Larsson IM, Brorsson C, Ostberg U, Oxenboll-Collet M, Savilampi J, Paskins S, Bottai M, Sackey PV. Development of an ICU discharge instrument predicting psychological morbidity: a multinational study. Intensive Care Med. 2018 Dec;44(12):2038-2047. doi: 10.1007/s00134-018-5467-3. Epub 2018 Nov 22.
- NICE Guidelines for ICU follow-upLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter V Sackey, MD, PhD study chair
Karolinska University Hospital
Anna Milton, MD principal investigator
Karolinska University Hospital
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disability and Depression, run by Karolinska University Hospital at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse psychological outcome (time frame: Three months post-ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02679157, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.