NCT00715494|CompletedDMC
A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial
RETURN
Returning to Everyday Tasks Utilizing Rehabilitation Networks (RETURN)
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RETURN
Returning to Everyday Tasks Utilizing Rehabilitation Networks (RETURN)
Sponsor study identifier
interventional
24
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
December 2015
Actual (reported)Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal cost to ICU survivors who frequently experience significant cognitive impairment and an array of physical and functional disabilities that limit their recovery and quality of life. While the problems experienced by these patients are likely amenable to rehabilitation, few ICU survivors receive focused rehabilitation following hospital discharge. The purpose of this study is to initiate and test the feasibility of a complex intervention incorporating a cognitive, physical, and functional rehabilitation program at the time of hospital discharge and implement this 12 week program using in-home visits and tele-technology. We hypothesize that this interdisciplinary rehabilitation program, initiated at hospital discharge and implemented using in-home visits and tele-technology, will result in improved recovery of neuropsychological and physical performance and overall functional status.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 10, 2008
Actual (reported)July 15, 2008
Actual (reported)September 2009
Actual (reported)December 2015
Actual (reported)Tower Test - a psychometric measure of executive functioning
3 and 12 months post hospital discharge
Timed Up and Go (TUG), a timed test assessing physical strength and gait speed
3 and 12 months post-hospital discharge
Step Activity Monitor (SAM), a device that measures total level of participant activity
3 and 12 months post-hospital discharge
Pfeffers FAQ, a brief measure of higher order (IADL) functioning.
3 and 12 months post-hospital discharge
SF-36 global scores
3 and 12 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
3 and 12 months post hospital discharge
Activities-specific Balance Confidence Scale (ABC)
3 and 12 months post hospital discharge
Mortality
Within 12 months of hospital discharge
Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
Participants in the experimental group will receive a focused set of interdisciplinary home-based interventions over a 12 week period.
A multicomponent program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients in their home environments over a focused 12 week period with the aid of tele-technology to utilize the expertise of physical therapy, occupational therapy, and neuropsychology.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
E Wesley Ely, MD, MPH
Vanderbilt University School of Medicine
Helen Hoenig, MD, MPH
Duke University Medical Center, Durham VA Medical Center
24 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2008
Randomized Controlled Trial Comparing Traditional Pelvic Floor Rehabilitation to Pilates in Increasing Pelvic Muscles Strength.
Contact the study team to confirm eligibility.
First Posted
July 15, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
September 11, 2018
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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