Brain InjuryRETURNNCT00715494
A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial
A study testing Cognitive, physical, and functional rehabilitation in people with Brain Injury and Muscle Weakness, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Injury, Muscle Weakness
- What is being tested?
- Cognitive, physical, and functional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Injury, Muscle Weakness
- Being tested
- Cognitive, physical, and functional rehabilitation
- Keywords
- brain injuries, dementia, myopathies, muscle disorders
- Medical subject headings
- Brain Injuries, Muscle Weakness, Dementia, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive, physical, and functional rehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive, physical, and functional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tower Test - a psychometric measure of executive functioning
Measured: 3 and 12 months post hospital discharge
Timed Up and Go (TUG), a timed test assessing physical strength and gait speed
Measured: 3 and 12 months post-hospital discharge
Step Activity Monitor (SAM), a device that measures total level of participant activity
Measured: 3 and 12 months post-hospital discharge
Secondary outcomes (6)
Pfeffers FAQ, a brief measure of higher order (IADL) functioning.
Measured: 3 and 12 months post-hospital discharge
SF-36 global scores
Measured: 3 and 12 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
Measured: 3 and 12 months post hospital discharge
Activities-specific Balance Confidence Scale (ABC)
Measured: 3 and 12 months post hospital discharge
Mortality
Measured: Within 12 months of hospital discharge
Rehospitalization rate and number of hospital days
Measured: Within 12 months of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University School of Medicine, Duke University, Durham VA Medical Center
- Responsible party
- Principal investigator, Wes Ely, Vanderbilt University
- Investigators
- E Wesley Ely, MD, MPH, Principal investigator, Vanderbilt University School of MedicineHelen Hoenig, MD, MPH, Principal investigator, Duke University Medical Center, Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715494
- Sponsor's protocol ID
- 070971
- Acronym
- RETURN
- Status last verified
- Sep 2018
- First submitted
- 10 Jul 2008
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Returning to Everyday Tasks Utilizing Rehabilitation Networks (RETURN)
- ClinicalTrials.gov ID
- NCT00715494
- Acronym / sponsor ID
- RETURN / 070971
- Conditions
- Brain Injury, Muscle Weakness
- Keywords
- brain injuries, dementia, myopathies, muscle disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University School of Medicine, Duke University, Durham VA Medical Center
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Cognitive, physical, and functional rehabilitationParticipants in the experimental group will receive a focused set of interdisciplinary home-based interventions over a 12 week period. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive, physical, and functional rehabilitationA 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. | Behavioural | Group 2 - Intervention |
Primary outcome
Tower Test - a psychometric measure of executive functioning
Time frame: 3 and 12 months post hospital discharge
Timed Up and Go (TUG), a timed test assessing physical strength and gait speed
Time frame: 3 and 12 months post-hospital discharge
Step Activity Monitor (SAM), a device that measures total level of participant activity
Time frame: 3 and 12 months post-hospital discharge
6 secondary outcomes
Pfeffers FAQ, a brief measure of higher order (IADL) functioning.
Time frame: 3 and 12 months post-hospital discharge
SF-36 global scores
Time frame: 3 and 12 months post hospital discharge
Katz Activities of Daily Living (ADL) scale
Time frame: 3 and 12 months post hospital discharge
Activities-specific Balance Confidence Scale (ABC)
Time frame: 3 and 12 months post hospital discharge
Mortality
Time frame: Within 12 months of hospital discharge
Rehospitalization rate and number of hospital days
Time frame: Within 12 months of hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- ICU Delirium and Cognitive Impairment Study GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E Wesley Ely, MD, MPH principal investigator
Vanderbilt University School of Medicine
Helen Hoenig, MD, MPH principal investigator
Duke University Medical Center, Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive, physical, and functional rehabilitation in people with Brain Injury and Muscle Weakness, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tower Test - a psychometric measure of executive functioning (time frame: 3 and 12 months post hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.