Dementia Clinical Trial
— ACT-ICUOfficial title:
ACT-ICU Study: Activity and Cognitive Therapy in the Intensive Care Unit
Verified date | March 2017 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | June 2014 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | Vanderbilt University Medical Center |
United States,
Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill med — View Citation
Brummel NE, Jackson JC, Girard TD, Pandharipande PP, Schiro E, Work B, Pun BT, Boehm L, Gill TM, Ely EW. A combined early cognitive and physical rehabilitation program for people who are critically ill: the activity and cognitive therapy in the intensive care unit (ACT-ICU) trial. Phys Ther. 2012 Dec;92(12):1580-92. doi: 10.2522/ptj.20110414. — View Citation
Jackson JC, Ely EW, Morey MC, Anderson VM, Denne LB, Clune J, Siebert CS, Archer KR, Torres R, Janz D, Schiro E, Jones J, Shintani AK, Levine B, Pun BT, Thompson J, Brummel NE, Hoenig H. Cognitive and physical rehabilitation of intensive care unit survivors: results of the RETURN randomized controlled pilot investigation. Crit Care Med. 2012 Apr;40(4):1088-97. doi: 10.1097/CCM.0b013e3182373115. — View Citation
Schweickert WD, Herlitz J, Pohlman AS, Gehlbach BK, Hall JB, Kress JP. A randomized, controlled trial evaluating postinsertion neck ultrasound in peripherally inserted central catheter procedures. Crit Care Med. 2009 Apr;37(4):1217-21. doi: 10.1097/CCM.0b013e31819cee7f. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tower Test | A psychometric measure of executive functioning. | 3 months post hospital discharge | |
Secondary | Timed Up and Go (TUG) | A timed test assessing physical strength and gait speed. | 3 months post hospital discharge | |
Secondary | Functional Activities Questionnaire | A brief measure of higher order (IADL) functioning. | 3 months post hospital discharge | |
Secondary | EQ-5 Global Scores | The EQ-5 Global Scores is an assessment of quality of life. | 3 months post hospital discharge | |
Secondary | Katz Activities of Daily Living (ADL) scale | A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living. | 3 months post hospital discharge | |
Secondary | Activities-Specific Balance Confidence Scale (ABC) | 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. | 3 months post hospital discharge | |
Secondary | AD8 | A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities. | 3 months post hospital discharge | |
Secondary | Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE) | 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. | 3 months post hospital discharge | |
Secondary | Mini Mental State Exam (MMSE) | A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention. | 3 months post hospital discharge | |
Secondary | Dysexecutive Questionnaire (Dys Exec) | A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction. | 3 months post hospital discharge | |
Secondary | TRAILS A & B Test | 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). | 3 months post hospital discharge | |
Secondary | General and Employment Questionnaire | A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization. | 3 months post hospital discharge | |
Secondary | Canadian Study of Health and Aging (CHSA) Frailty Scale | A brief global rating scale of frailty based on clinical impression. | 3 months post hospital discharge | |
Secondary | Tower Test | A psychometric measure of executive functioning. | 12 months post hospital discharge | |
Secondary | Timed Up and Go (TUG) | A timed test assessing physical strength and gait speed. | 12 months post hospital discharge | |
Secondary | Functional Activities Questionnaire | A brief measure of higher order (IADL) functioning. | 12 months post-hospital discharge | |
Secondary | EQ-5 Global Scores | The EQ-5 Global Scores is an assessment of quality of life. | 12 months post hospital discharge | |
Secondary | Katz Activities of Daily Living (ADL) scale | A six-item tool assessing the degree of independence vs. dependence in basic activities of daily living. | 12 months post hospital discharge | |
Secondary | Activities-Specific Balance Confidence Scale (ABC) | 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. | 12 months post hospital discharge | |
Secondary | AD8 | A brief surrogate or patient based measure that assesses recent change in a variety of cognitive abilities. | 12 months post hospital discharge | |
Secondary | Short-Informant Questionnaire of Cognitive Decline in the Elderly (Short IQCODE) | 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. | 12 months post hospital discharge | |
Secondary | Mini Mental State Exam (MMSE) | A widely used measure of overall cognitive functioning that briefly samples abilities in a wide array of areas including memory and attention. | 12 months post hospital discharge | |
Secondary | Dysexecutive Questionnaire (Dys Exec) | A questionnaire, which has both patient and surrogate versions, that assesses patient functioning in a number of functional areas sensitive to executive dysfunction. | 12 months post hospital discharge | |
Secondary | TRAILS A & B Test | 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). | 12 months post hospital discharge | |
Secondary | General and Employment Questionnaire | A brief series of questions which pertain to patient history and demographics and which also inquire about employment both before and after ICU hospitalization. | 12 months post hospital discharge | |
Secondary | Canadian Study of Health and Aging (CHSA) Frailty Scale | A brief global rating scale of frailty based on clinical impression. | 12 months post hospital discharge | |
Secondary | Mortality | 2 months post hospital discharge | ||
Secondary | Rehospitalization rate and number of hospital days | 12 months post hospital discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |