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

NCT00715494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-09-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt University School of Medicine

    collaborator OTHER
  • Duke University

    collaborator OTHER
  • Durham VA Medical Center

    collaborator FED
  • Vanderbilt University

    lead OTHER

Principal Investigators

  • E Wesley Ely, MD, MPH · Vanderbilt University School of Medicine

  • Helen Hoenig, MD, MPH · Duke University Medical Center, Durham VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-09-30
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715494 on ClinicalTrials.gov