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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Vanderbilt University School of Medicine
Duke University
Durham VA Medical Center
Information provided by (Responsible Party):
Wes Ely, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00715494
First received: July 10, 2008
Last updated: June 18, 2014
Last verified: June 2014

July 10, 2008
June 18, 2014
July 2008
September 2009   (final data collection date for primary outcome measure)
  • Tower Test - a psychometric measure of executive functioning [ Time Frame: 3 and 12 months post hospital discharge ] [ Designated as safety issue: No ]
  • Timed Up and Go (TUG), a timed test assessing physical strength and gait speed [ Time Frame: 3 and 12 months post-hospital discharge ] [ Designated as safety issue: No ]
  • Step Activity Monitor (SAM), a device that measures total level of participant activity [ Time Frame: 3 and 12 months post-hospital discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00715494 on ClinicalTrials.gov Archive Site
  • Pfeffers FAQ, a brief measure of higher order (IADL) functioning. [ Time Frame: 3 and 12 months post-hospital discharge ] [ Designated as safety issue: No ]
  • SF-36 global scores [ Time Frame: 3 and 12 months post hospital discharge ] [ Designated as safety issue: No ]
  • Katz Activities of Daily Living (ADL) scale [ Time Frame: 3 and 12 months post hospital discharge ] [ Designated as safety issue: No ]
  • Activities-specific Balance Confidence Scale (ABC) [ Time Frame: 3 and 12 months post hospital discharge ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Within 12 months of hospital discharge ] [ Designated as safety issue: No ]
  • Rehospitalization rate and number of hospital days [ Time Frame: Within 12 months of hospital discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial
Returning to Everyday Tasks Utilizing Rehabilitation Networks (RETURN)

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Brain Injury
  • Muscle Weakness
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.
  • 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.
    Intervention: Behavioral: Cognitive, physical, and functional rehabilitation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
130
December 2015
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00715494
070971
Yes
Wes Ely, Vanderbilt University
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
Vanderbilt University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP