A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial (RETURN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00715494
Recruitment Status : Active, not recruiting
First Posted : July 15, 2008
Last Update Posted : March 1, 2018
Vanderbilt University School of Medicine
Duke University
Durham VA Medical Center
Information provided by (Responsible Party):
Wes Ely, Vanderbilt University

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 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.

Condition or disease Intervention/treatment Phase
Brain Injury Muscle Weakness Behavioral: Cognitive, physical, and functional rehabilitation Not Applicable

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 this study is to pilot test a 12-week, home-based rehabilitation program targeting both cognitive functioning and physical functioning, to determine the feasibility of such a rehabilitation program, and to determine whether participation in a rehabilitation program will result in improved outcomes among ICU survivors. The study will rely on a randomized controlled clinical trial design, with patients assigned to either a "usual care" control group vs. the treatment group. Individuals in the treatment group will receive a protocolized cognitive rehabilitation intervention, as well as individualized physical and functional rehabilitation targeted at abilities such as strength, endurance, balance, and functionality in basic tasks of daily living. Cognitive, physical, and functional rehabilitation interventions will be delivered in patient homes and will take place on alternating weeks over a 12 week period. Televideo technology will be employed in the context of these interventions, with experts from Vanderbilt University and Duke University medical centers providing assistance via a video monitor in conjunction with a rehabilitation specialist who will implement interventions in patient homes. The study has 3 primary outcomes including: (1). Executive functioning (e.g. ability to plan, organize, multi-task) over time as measured by the Tower Test, a psychometric tool evaluating executive abilities; (2) Physical Impairment, as measured by the Timed Up and Go (TUG) test; (3) Physical Functioning, as measured by the Step Activity Monitor (SAM). These three primary outcomes have been selected as areas of primary focus due to the fact that available research points to the presence of significant deficits in these areas among ICU survivors. Secondary outcomes include activities of daily living (Katz ADL) and instrumental activities of daily living (Pfeffers FAQ), activity specific balance and confidence(ABC Scale), health related quality of life (SF-36), 12-month mortality, and both rehospitalization rates and number of rehospitalization days. We will measure change in the outcome measures of interest at 3 and 12-month follow up to determine short term efficacy, along with evaluating overall feasibility. The study duration will include 1 year of protocol development for the complex intervention and 1.5 to 2 years of enrollment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This was a single-site, feasibility, pilot, randomized trial of 21 general medical/surgical intensive care unit survivors (8 controls and 13 intervention patients) with either cognitive or functional impairment at hospital discharge. After discharge, study controls received usual care (sporadic rehabilitation), whereas intervention patients received a combination of in-home cognitive, physical, and functional rehabilitation over a 3-month period via a social worker or master's level psychology technician utilizing telemedicine to allow specialized multidisciplinary treatment. Interventions over 12 wks included six in-person visits for cognitive rehabilitation and six televisits for physical/functional rehabilitation.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Returning to Everyday Tasks Utilizing Rehabilitation Networks (RETURN)
Study Start Date : July 2008
Actual Primary Completion Date : September 2009
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Group 1 - Control
Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
Experimental: Group 2 - Intervention
Participants in the experimental group will receive a focused set of interdisciplinary home-based interventions over a 12 week period.
Behavioral: Cognitive, physical, and functional rehabilitation
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.

Primary Outcome Measures :
  1. Tower Test - a psychometric measure of executive functioning [ Time Frame: 3 and 12 months post hospital discharge ]
  2. Timed Up and Go (TUG), a timed test assessing physical strength and gait speed [ Time Frame: 3 and 12 months post-hospital discharge ]
  3. Step Activity Monitor (SAM), a device that measures total level of participant activity [ Time Frame: 3 and 12 months post-hospital discharge ]

Secondary Outcome Measures :
  1. Pfeffers FAQ, a brief measure of higher order (IADL) functioning. [ Time Frame: 3 and 12 months post-hospital discharge ]
  2. SF-36 global scores [ Time Frame: 3 and 12 months post hospital discharge ]
  3. Katz Activities of Daily Living (ADL) scale [ Time Frame: 3 and 12 months post hospital discharge ]
  4. Activities-specific Balance Confidence Scale (ABC) [ Time Frame: 3 and 12 months post hospital discharge ]
  5. Mortality [ Time Frame: Within 12 months of hospital discharge ]
  6. Rehospitalization rate and number of hospital days [ Time Frame: Within 12 months of hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00715494

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Vanderbilt University School of Medicine
Duke University
Durham VA Medical Center
Principal Investigator: E Wesley Ely, MD, MPH Vanderbilt University School of Medicine
Principal Investigator: Helen Hoenig, MD, MPH Duke University Medical Center, Durham VA Medical Center

Additional Information:
Responsible Party: Wes Ely, Professor of Medicine, Vanderbilt University Identifier: NCT00715494     History of Changes
Other Study ID Numbers: 070971
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Keywords provided by Wes Ely, Vanderbilt University:
brain injuries, dementia, myopathies, muscle disorders

Additional relevant MeSH terms:
Brain Injuries
Muscle Weakness
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms