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

NCT00715494 | Completed DMC

• 1 other identifier: 070971
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury; Muscle Weakness

Keywords

brain injuries, dementia, myopathies, muscle disorders

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Group 1 - Control

NO INTERVENTION

Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.

Group 2 - Intervention

EXPERIMENTAL

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

Interventions

Cognitive, physical, and functional rehabilitation BEHAVIORAL

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.

Group 2 - Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Vanderbilt University School of Medicine: collaborator
• Duke University: collaborator
• Durham VA Medical Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• ICU Delirium and Cognitive Impairment Study Group

MeSH Terms

Conditions

Brain Injuries; Muscle Weakness; Dementia; Muscular Diseases

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• E Wesley Ely, MD, MPH

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

• Helen Hoenig, MD, MPH

  Duke University Medical Center, Durham VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 15, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2015
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

US (1)