ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nathan Brummel, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01270269
First received: November 2, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Brain Injuries
Dementia
Myopathies
Muscle Disorders
Behavioral: Behavioral: Physical and functional rehabilitation
Behavioral: Behavioral: Cognitive, physical, & functional rehabilitation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Tower Test [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A psychometric measure of executive functioning.


Secondary Outcome Measures:
  • Timed Up and Go (TUG) [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A timed test assessing physical strength and gait speed.

  • Functional Activities Questionnaire [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief measure of higher order (IADL) functioning.

  • EQ-5 Global Scores [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    The EQ-5 Global Scores is an assessment of quality of life.

  • Katz Activities of Daily Living (ADL) scale [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living.

  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief rating scale that asks participants to rate how confident they are that they can maintain their balance and remain steady while engaged in 16 non-hazardous tasks.

  • AD8 [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.

  • Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE) [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A measure of cognitive functioning that evaluates the degree of decline from baseline and which is complementary to the AD8. This measure will only be used in patients over the age of 50 who had any problems with memory or thinking prior to current illness.

  • Mini Mental State Exam (MMSE) [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention.

  • Dysexecutive Questionnaire (Dys Exec) [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction.

  • TRAILS A & B Test [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    Two widely used to test the speed that it takes to connect a series of numbers (Part A) and numbers alternating with letters (Part B).

  • General and Employment Questionnaire [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization.

  • Canadian Study of Health and Aging (CHSA) Frailty Scale [ Time Frame: 3 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief global rating scale of frailty based on clinical impression.

  • Tower Test [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A psychometric measure of executive functioning.

  • Timed Up and Go (TUG) [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A timed test assessing physical strength and gait speed.

  • Functional Activities Questionnaire [ Time Frame: 12 months post-hospital discharge ] [ Designated as safety issue: No ]
    A brief measure of higher order (IADL) functioning.

  • EQ-5 Global Scores [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    The EQ-5 Global Scores is an assessment of quality of life.

  • Katz Activities of Daily Living (ADL) scale [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living.

  • Activities-Specific Balance Confidence Scale (ABC) [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief rating scale that asks participants to rate how confident they are that they can maintain their balance and remain steady while engaged in 16 non-hazardous tasks.

  • AD8 [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities.

  • Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE) [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A measure of cognitive functioning that evaluates the degree of decline from baseline and which is complementary to the AD8. This measure will only be used in patients over the age of 50 who had any problems with memory or thinking prior to current illness.

  • Mini Mental State Exam (MMSE) [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention.

  • Dysexecutive Questionnaire (Dys Exec) [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction.

  • TRAILS A & B Test [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    Two widely used to test the speed that it takes to connect a series of numbers (Part A) and numbers alternating with letters (Part B).

  • General and Employment Questionnaire [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization.

  • Canadian Study of Health and Aging (CHSA) Frailty Scale [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]
    A brief global rating scale of frailty based on clinical impression.

  • Mortality [ Time Frame: 2 months post hospital discharge ] [ Designated as safety issue: No ]
  • Rehospitalization rate and number of hospital days [ Time Frame: 12 months post hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: February 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Patients (Controls)
Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
Experimental: Behavioral: Phys & Func Rehab
A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
Behavioral: Behavioral: Physical and functional rehabilitation
A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
Other Name: cognitive rehabilitation
Experimental: Behavioral: Cog/Phys/Func Rehab
A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.
Behavioral: Behavioral: Cognitive, physical, & functional rehabilitation
A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.
Other Name: cognitive rehabilitation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients admitted to the medical or surgical ICU who are receiving treatment for respiratory failure, cardiogenic shock, hemorrhagic shock, and/or septic shock.

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);
  • Moderate or severe physical dysfunction that precludes performance of independent activities of daily living based on a standardized surrogate assessment;
  • Live greater than 120 miles from Nashville;
  • Blind, deaf, or unable to speak English;
  • Prisoners;
  • Homelessness and no secondary contact person available
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270269

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Nathan E. Brummel, MD Vanderbilt University School of Medicine
  More Information

Publications:
Responsible Party: Nathan Brummel, Clinical Fellow, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01270269     History of Changes
Other Study ID Numbers: 101037
Study First Received: November 2, 2010
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Asthenia
Muscle Weakness
Brain Injuries
Critical Illness
Critical Illness Myoneuropathy
Rehabilitation
Sepsis
Respiratory Failure
Delirium
Over-sedation
Immobility
Aging
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:
Brain Injuries
Muscular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Musculoskeletal Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 19, 2014