Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:41 PM
Study NCT ID:
NCT01270269
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2010-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT-ICU
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. Recently, early physical rehabilitation in ICU patients has shown to improve the chances a patient will regain their pre-hospital functional status. Early cognitive rehabilitation for these patients has not yet been explored. This pilot study will determine the feasibility of early cognitive rehabilitation in ICU patients. The investigators will perform cognitive and physical rehabilitation, beginning in the earliest phases of critical illness, to determine the effect of these therapies on cognitive and functional outcomes in ICU survivors. The investigators hypothesize that combined cognitive and physical rehabilitation, started in the ICU, will improve recovery of cognitive and physical function as well as improve quality of life of ICU survivors.
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 multi-component, cognitive and physical rehabilitation program beginning in the ICU, combined with a 12-week home-based cognitive rehabilitation program following hospital discharge 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 one of three groups: a "usual care" control group, an early physical activity group (without cognitive therapy), or an early cognitive therapy and physical activity group. All individuals in the intervention groups will receive protocolized physical therapy while hospitalized. In addition, individuals in the early cognitive therapy and physical activity group will receive cognitive therapy starting in the ICU and continuing for 12 weeks once a patient leaves the hospital. In-home visits will occur every other week during the 12-week intervention period.
The study's primary outcome is executive functioning (e.g. ability to plan, organize, multi-task) at 3-months following hospital discharge as measured by the Tower Test, a psychometric tool evaluating executive abilities. This has been chosen due to the fact that available research points to the presence of significant deficits in executive functioning among ICU survivors. Secondary outcomes include global cognitive function, physical function and Health Related Quality of Life by assessing scores on the following measures: Katz's ADL, Functional Activities Questionnaire, AD8, Short-Informant Questionnaire of Cognitive Decline in the Elderly, Clinical Dementia Rating Scale (if performed), Timed Up \& Go test, Mini-Mental State Exam, Dysexecutive Questionnaire, Activities-Specific Balance Confidence Scale, Behavior Rating Inventory of Executive Function, Behavior Pain Inventory, Trails A \& B test, Repeatable Battery for Assessment of Neuropsychological Status, General Employment Questionnaire, Beck Depression Inventory II, Post-traumatic stress checklist, Short Form 36, Canadian Study of Health and Aging and patient weight, and Tower Test score at 12 month follow-up. We will also track readmission to the hospital and admission to a nursing home or skilled rehabilitation facility as secondary outcomes during the 12-month follow-up period. The study duration will include 1 year of enrollment and 1 year for study completion following enrollment of the final patient.
The study's primary outcome is executive functioning (e.g. ability to plan, organize, multi-task) at 3-months following hospital discharge as measured by the Tower Test, a psychometric tool evaluating executive abilities. This has been chosen due to the fact that available research points to the presence of significant deficits in executive functioning among ICU survivors. Secondary outcomes include global cognitive function, physical function and Health Related Quality of Life by assessing scores on the following measures: Katz's ADL, Functional Activities Questionnaire, AD8, Short-Informant Questionnaire of Cognitive Decline in the Elderly, Clinical Dementia Rating Scale (if performed), Timed Up \& Go test, Mini-Mental State Exam, Dysexecutive Questionnaire, Activities-Specific Balance Confidence Scale, Behavior Rating Inventory of Executive Function, Behavior Pain Inventory, Trails A \& B test, Repeatable Battery for Assessment of Neuropsychological Status, General Employment Questionnaire, Beck Depression Inventory II, Post-traumatic stress checklist, Short Form 36, Canadian Study of Health and Aging and patient weight, and Tower Test score at 12 month follow-up. We will also track readmission to the hospital and admission to a nursing home or skilled rehabilitation facility as secondary outcomes during the 12-month follow-up period. The study duration will include 1 year of enrollment and 1 year for study completion following enrollment of the final patient.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: