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Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00896220
Acronym
RECOVER
Enrollment
500
Registered
2009-05-11
Start date
2006-04-30
Completion date
2012-10-31
Last updated
2009-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill

Keywords

chronic critical illness, mechanical ventilation, outcomes, weakness, quality of life, Critically Ill patients and their family caregiver

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: 1. There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation. 2. 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). 3. 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

Interventions

None listed

Sponsors

Canadian Critical Care Trials Group
CollaboratorOTHER
Ontario Ministry of Health and Long Term Care
CollaboratorOTHER_GOV
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frame
Functional Independence Measure (FIM) - ICU Survivor7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Six Minute Walking Test (6MWT) - ICU Survivor7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge

Secondary

MeasureTime frame
Impact of Event Scale (IES) - ICU Survivor3 months, 6 months, 12 months and 24 months post-ICU discharge
Hospital mortality - ICU Survivor1 and 2 years post-ICU discharge
Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources/Costs) - ICU Survivor3 months, 6 months, 12 months and 24 months post-ICU discharge
The Positive Affect Scale (PAS) - Family Caregivers7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - ICU Survivor3 months, 6 months, 12 months and 24 months post-ICU discharge
Medical Outcomes Study Short Form -36 Questionnaire (SF-36) - Family Caregivers7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Impact Scale (CIS) - Family Caregivers7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Care-giving Assistance Scale (CAS) - Family Caregivers7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The 4-item Personal Gain Scale & Pearlin's Mastery Scale - Family Caregivers7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
The Centre for Epidemiological Studies Depression Scale (CESD) - Family Caregivers7 days, 3 months, 6 months, 12 months and 24 months post-ICU discharge
Beck Depression Inventory-II (BDI-II) - ICU Survivor3 months, 6 months, 12 months and 24 months post-ICU discharge

Countries

Canada

Contacts

Primary ContactAndrea Matte, RRT
andrea.matte@uhn.on.ca416-340-3057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026