Critically IllRECOVERNCT00896220
Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers
An observational study of Critically Ill, run by University Health Network, Toronto at 5 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critically Ill
- How many people
- 500 participants
- Where
- 5 sitesCanada
- Study dates
- Apr 2006to Oct 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill individuals who require mechanical ventilation for one week or greater and their primary family caregiver
Who may be able to join
- Older than 16 years of age.
- Mechanically ventilated for a minimum of one week in study ICU.
Who cannot join
- 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.
Show all 12Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Sunnybrook
Toronto, Ontario, M4N 3M5
Neill Adhikari, MD, neil.adhikari@sunnybrook.ca
Neill Adhikari, MD FRCPC MSc
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Jan Friedrich, MD
Jan Friedrich, PhD MD FRCPC
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Sangeeta Mehta, MD, geeta.mehta@utoronto.ca
Sangeeta Mehta, MD FRCPC
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5G 2C4
Andrea Matte, RRT, 416-603-5967, andrea.matte@uhn.on.ca
Niall Ferguson, MD FRCPC MSc
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Andrea Matte, RRT, 416-603-5967, andrea.matte@uhn.on.ca
Margaret S. Herridge, MSc MD FRCPC MPH
About this study
Official title: Towards RECOVER - Rehabilitation and Recovery in Survivors of Critical Illness. Long-Term Outcomes and Needs Assessment in ICU Survivors of Prolonged Mechanical Ventilation and Their Caregivers
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:
- There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation.
- There is inadequate information about the needs of survivors of prolonged mechanical ventilation and their family caregivers across the trajectory of illness (i.e., from the ICU to the community).
- There is a poor understanding of the development of ICU-acquired muscle injury.
Read more
Towards RECOVER is the very first study to identify survivors of prolonged mechanical ventilation who are at-risk for poor functional outcomes, to identify elements of the care-giving situation that put caregivers at risk for poor quality of life and mental health, to catalogue the rehabilitative needs of patients and family caregivers across the illness trajectory, and to evaluate the mechanism of critical illness associated muscle injury.
The RECOVER Program consists of Four Phases:
- Phase I: Towards RECOVER
- Phase II: RECOVER development and pilot testing
- Phase III: RECOVER randomized controlled trial
- Phase IV: Long-term implementation of RECOVER
- Conditions
- Critically Ill
- Keywords
- chronic critical illness, mechanical ventilation, outcomes, weakness, quality of life, Critically Ill patients and their family caregiver
- Medical subject headings
- Critical Illness, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM) - ICU Survivor
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Six Minute Walking Test (6MWT) - ICU Survivor
Measured: 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
Measured: 3 months, 6 months, 12 months and 24 months post-ICU discharge
Beck Depression Inventory-II (BDI-II) - ICU Survivor
Measured: 3 months, 6 months, 12 months and 24 months post-ICU discharge
Impact of Event Scale (IES) - ICU Survivor
Measured: 3 months, 6 months, 12 months and 24 months post-ICU discharge
Hospital mortality - ICU Survivor
Measured: 1 and 2 years post-ICU discharge
Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor
Measured: 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Positive Affect Scale (PAS) - Family Caregivers
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Impact Scale (CIS) - Family Caregivers
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Assistance Scale (CAS) - Family Caregivers
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers
Measured: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study startApr 2006
- Primary completionOct 2010 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Investigators
- Margaret Herridge, MSc MD MPH, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896220
- Sponsor's protocol ID
- 06-0157-AE
- Other IDs
- IHP-94531
- Acronym
- RECOVER
- Status last verified
- May 2009
- First submitted
- 8 May 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12594312Cameron 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.
PubMed 16374160Cheung 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.
PubMed 16763220Cameron 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.
PubMed 27168433Czerwonka 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.
PubMed 25466314
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards RECOVER - Rehabilitation and Recovery in Survivors of Critical Illness. Long-Term Outcomes and Needs Assessment in ICU Survivors of Prolonged Mechanical Ventilation and Their Caregivers
- ClinicalTrials.gov ID
- NCT00896220
- Acronym / sponsor ID
- RECOVER / 06-0157-AE
- Conditions
- Critically Ill
- Keywords
- chronic critical illness, mechanical ventilation, outcomes, weakness, quality of life, Critically Ill patients and their family caregiver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Critical Care Trials Group, Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2006
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 11 May 2009 (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.
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:
- There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation.
- There is inadequate information about the needs of survivors of prolonged mechanical ventilation and their family caregivers across the trajectory of illness (i.e., from the ICU to the community).
- There is a poor understanding of the development of ICU-acquired muscle injury.
Towards RECOVER is the very first study to identify survivors of prolonged mechanical ventilation who are at-risk for poor functional outcomes, to identify elements of the care-giving situation that put caregivers at risk for poor quality of life and mental health, to catalogue the rehabilitative needs of patients and family caregivers across the illness trajectory, and to evaluate the mechanism of critical illness associated muscle injury.
The RECOVER Program consists of Four Phases:
- Phase I: Towards RECOVER
- Phase II: RECOVER development and pilot testing
- Phase III: RECOVER randomized controlled trial
- Phase IV: Long-term implementation of RECOVER
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill individuals who require mechanical ventilation for one week or greater and their primary family caregiver
Key inclusion criteria (2 listed)
- Older than 16 years of age.
- Mechanically ventilated for a minimum of one week in study ICU.
Key exclusion criteria (12 listed)
- 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.
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
Functional Independence Measure (FIM) - ICU Survivor
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Six Minute Walking Test (6MWT) - ICU Survivor
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
11 secondary outcomes
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor
Time frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
Beck Depression Inventory-II (BDI-II) - ICU Survivor
Time frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
Impact of Event Scale (IES) - ICU Survivor
Time frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
Hospital mortality - ICU Survivor
Time frame: 1 and 2 years post-ICU discharge
Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor
Time frame: 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Positive Affect Scale (PAS) - Family Caregivers
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Impact Scale (CIS) - Family Caregivers
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Assistance Scale (CAS) - Family Caregivers
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers
Time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
- Background: PubMed 12594312Herridge 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.
- Background: PubMed 16374160Cameron 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.
- Background: PubMed 16763220Cheung 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.
- Derived from this study: PubMed 27168433Cameron 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.
- Derived from this study: PubMed 25466314Czerwonka 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.
Related trials for Critically Ill
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
Margaret Herridge, MSc MD MPH principal investigator
University Health Network, Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by University Health Network, Toronto at 5 sites in Canada.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Matte, RRT (416-340-3057, andrea.matte@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) - ICU Survivor (time frame: 7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge). 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 NCT00896220, which also lists 5 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 9 Oct 2009.