Status:
COMPLETED
A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Vanderbilt University School of Medicine
Duke University
Conditions:
Brain Injury
Muscle Weakness
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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...
Detailed Description
The long-term consequences of critical illness and intensive care unit (ICU) hospitalization in ICU survivors are profound and include cognitive, physical, and functional impairments. The purpose of t...
Eligibility Criteria
Inclusion
- Enrollment in the BRAIN-ICU study (AG027472-01A1), the presence of cognitive impairment defined via an abnormal Tower Test score (at the time of hospital discharge) and/or physical impairment defined per standard cutpoints for the Timed Up and Go Test (at the time of hospital discharge);
- The ability to walk with or without assistance.
Exclusion
- Moderate to severe dementia on ICU admission based on a standardized surrogate assessment (as this would prohibit patients from functioning independently at home);
- The presence of normal cognition and normal physical function at the time of screening (i.e. hospital discharge) which would eliminate the need for rehabilitation;
- Lacking telephone service with an analog telephone line (which would preclude the tele-video component of the RETURN intervention).
- Live greater than 125 miles from Nashville
- Patient is unable to provide informed consent.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00715494
Start Date
July 1 2008
End Date
December 1 2015
Last Update
September 11 2018
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232