NCT00896220

Brief Summary

Advances in critical care medicine have dramatically improved the survival of critically ill patients requiring prolonged mechanical ventilation. However, there are no systematic follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients or their family caregivers who contribute to survivor recovery and rehabilitation. Major barriers to developing these programs for survivors of prolonged mechanical ventilation and their caregivers include the following:

  • Phase I: Towards RECOVER
  • Phase II: RECOVER development and pilot testing
  • Phase III: RECOVER randomized controlled trial
  • Phase IV: Long-term implementation of RECOVER

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 9, 2009

Status Verified

May 1, 2009

Enrollment Period

4.5 years

First QC Date

May 8, 2009

Last Update Submit

October 8, 2009

Conditions

Critically Ill

Keywords

chronic critical illnessmechanical ventilationoutcomesweaknessquality of lifeCritically Ill patients and their family caregiver

Outcome Measures

Primary Outcomes (2)

  • Functional Independence Measure (FIM) - ICU Survivor

    7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge

  • Six Minute Walking Test (6MWT) - ICU Survivor

    7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge

Secondary Outcomes (11)

  • Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor

    3 months, 6 months, 12 months and 24 months post-ICU discharge

  • Beck Depression Inventory-II (BDI-II) - ICU Survivor

    3 months, 6 months, 12 months and 24 months post-ICU discharge

  • Impact of Event Scale (IES) - ICU Survivor

    3 months, 6 months, 12 months and 24 months post-ICU discharge

  • Hospital mortality - ICU Survivor

    1 and 2 years post-ICU discharge

  • Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor

    3 months, 6 months, 12 months and 24 months post-ICU discharge

  • +6 more secondary outcomes

Study Arms (1)

ICU Survivors and Their Family Caregiver

ICU Survivors who required one week or more of mechanical ventilation during their critical illness and their primary family caregiver

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill individuals who require mechanical ventilation for one week or greater and their primary family caregiver

You may qualify if:

  • Older than 16 years of age.
  • Mechanically ventilated for a minimum of one week in study ICU.

You may not qualify if:

  • Catastrophic Neurological Injury in the opinion of the attending intensivist (ex. Grade V SAH or massive CVA).
  • Pre-existing Formal diagnosis of neuromuscular disease.
  • Non-ambulatory prior to hospital or ICU admission.
  • Anticipated death or withdrawal of life sustaining treatment within 48 hours.
  • History of psychiatric illness with documented admission.
  • Patient is not fluent in English.
  • Documented discussion re: imminent withdrawal of life sustaining treatment.
  • Lives greater than 300 km from referral centre.
  • Patient no living at a fixed address.
  • Physician refusal.
  • Patient of SDM (substitute decision maker) refuses consent.
  • No next of kin of SDM available (if patient unable to provide consent).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Related Publications (5)

  • Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

    PMID: 12594312BACKGROUND

  • Cameron JI, Herridge MS, Tansey CM, McAndrews MP, Cheung AM. Well-being in informal caregivers of survivors of acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):81-6. doi: 10.1097/01.ccm.0000190428.71765.31.

    PMID: 16374160BACKGROUND

  • Cheung AM, Tansey CM, Tomlinson G, Diaz-Granados N, Matte A, Barr A, Mehta S, Mazer CD, Guest CB, Stewart TE, Al-Saidi F, Cooper AB, Cook D, Slutsky AS, Herridge MS. Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Sep 1;174(5):538-44. doi: 10.1164/rccm.200505-693OC. Epub 2006 Jun 8.

    PMID: 16763220BACKGROUND

  • Cameron JI, Chu LM, Matte A, Tomlinson G, Chan L, Thomas C, Friedrich JO, Mehta S, Lamontagne F, Levasseur M, Ferguson ND, Adhikari NK, Rudkowski JC, Meggison H, Skrobik Y, Flannery J, Bayley M, Batt J, dos Santos C, Abbey SE, Tan A, Lo V, Mathur S, Parotto M, Morris D, Flockhart L, Fan E, Lee CM, Wilcox ME, Ayas N, Choong K, Fowler R, Scales DC, Sinuff T, Cuthbertson BH, Rose L, Robles P, Burns S, Cypel M, Singer L, Chaparro C, Chow CW, Keshavjee S, Brochard L, Hebert P, Slutsky AS, Marshall JC, Cook D, Herridge MS; RECOVER Program Investigators (Phase 1: towards RECOVER); Canadian Critical Care Trials Group. One-Year Outcomes in Caregivers of Critically Ill Patients. N Engl J Med. 2016 May 12;374(19):1831-41. doi: 10.1056/NEJMoa1511160.

    PMID: 27168433DERIVED

  • Czerwonka AI, Herridge MS, Chan L, Chu LM, Matte A, Cameron JI. Changing support needs of survivors of complex critical illness and their family caregivers across the care continuum: a qualitative pilot study of Towards RECOVER. J Crit Care. 2015 Apr;30(2):242-9. doi: 10.1016/j.jcrc.2014.10.017. Epub 2014 Oct 30.

    PMID: 25466314DERIVED

MeSH Terms

Conditions

Critical IllnessAsthenia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Margaret Herridge, MSc MD MPH

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Matte, RRT

CONTACT

416-340-3057andrea.matte@uhn.on.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

April 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2012

Last Updated

October 9, 2009

Record last verified: 2009-05

Locations

CA(5)