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| ID | Type | Description | Link |
|---|---|---|---|
| 40067 | Other Grant/Funding Number | American Association of Critical-Care Nurses (AACN) |
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| Name | Class |
|---|---|
| American Association of Critical Care Nurses | OTHER |
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More than 60% of intensive care unit (ICU) patients are adults ages 60 and older, who are at high risk for ICU-acquired cognitive impairment. After ICU discharge, ICU survivors often experience sleep disturbances and inactivity, and almost 80% of ICU patients experience disturbances in circadian rhythm, which may affect cognitive function. Understanding the optimal, chronotherapeutic timing of cognitive interventions is crucial to promote circadian realignment and cognitive function, and may improve intervention feasibility, acceptability, and efficacy. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention [COG]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care [UC]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function.
Over 60% of intensive care unit (ICU) patients are older adults (ages 60 and older). Up to 40% of ICU survivors experience cognitive impairment that is comparable in severity to moderate traumatic brain injury, while 25% have symptoms similar to mild Alzheimer's disease after hospital discharge. Older ICU survivors are at high risk for ICU-acquired cognitive impairment, often leading to a protracted recovery in a care facility. Several factors, including circadian misalignment (observed in about 75-80% of ICU patients), may decrease effects of interventions designed to improve cognitive function. Further, daytime activity is essential for recovery from critical illness and to promote circadian realignment, yet ICU survivors experience profound inactivity. The scientific premise of the proposed research is that identifying the optimal circadian timing of cognitive interventions for older ICU survivors may improve intervention feasibility, acceptability, and efficacy. Interventions targeting symptoms (i.e., disturbances in circadian rhythm and cognitive impairment) may deliver similar outcomes across conditions that require ICU admission (e.g., cancer, heart failure, pneumonia, hip fracture). To date, interventions have not been evaluated in older ICU survivors that simultaneously target circadian misalignment and cognitive impairment. Moreover, because circadian misalignment adversely affects cognitive function, understanding the optimal timing of cognitive interventions is crucial to promote both circadian realignment and cognitive function. Specific Aim 1 will determine feasibility, acceptability, and preliminary effect sizes for: 1) a morning session of a computerized cognitive training intervention [COG]; and 2) a late afternoon/early evening session of the COG intervention; compared to 3) standard inpatient care/usual care [UC]. Specific Aim 2 will examine circadian rhythm parameters to determine the optimal timing of the daily COG intervention. Exploratory Aim 3 will explore if the effects of the COG intervention on cognitive function are mediated by daytime activity, and explore if selected biological and clinical factors moderate intervention effects on cognitive function. The proposed early-stage clinical trial will be the first to evaluate chronotherapeutic timing of a computerized cognitive training intervention for hospitalized older ICU survivors after ICU discharge, to initiate early cognitive recovery on a post-ICU unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COG-AM | Experimental | 30-minute morning session of a laptop-based computerized cognitive training intervention, delivered between the hours of 09:00 AM - 12:00 PM, in addition to UC |
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| COG-PM | Experimental | 30-minute afternoon/evening session of a laptop-based computerized cognitive training intervention, delivered between the hours of 15:00 PM - 18:00 PM, in addition to UC |
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| UC | No Intervention | Standard post-ICU inpatient care/usual care, which includes physical/occupational therapy as ordered by treatment team |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COG-AM | Behavioral | Participants who are randomized to the COG-AM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during morning hours (between 09:00-12:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of morning-only sessions of computerized cognitive training | A retention rate of >70% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-AM sessions and all cognitive outcome assessments. Adherence to the COG-AM intervention will be defined as the proportion of minutes spent training by the total minutes required per protocol (total minutes trained / [30 minutes x number of intervention days]). | 7 days |
| Feasibility of afternoon/evening-only sessions of computerized cognitive training | A retention rate of >70% will determine feasibility: the percentage of participants who complete at least 60 minutes of COG-PM sessions and all cognitive outcome assessments. Adherence to the COG-PM intervention will be defined as the proportion of minutes spent training by the total minutes required per protocol (total minutes trained / [30 minutes x number of intervention days]). | 7 days |
| Acceptability of morning-only sessions of computerized cognitive training | Likert-type surveys including open-ended questions will be collected regarding acceptability of the COG-AM intervention. To evaluate tolerability, reasons why participants were unable to complete COG-AM sessions in their entirety will be recorded. | 7 days |
| Acceptability of afternoon/evening-only sessions of computerized cognitive training | Likert-type surveys including open-ended questions will be collected regarding acceptability of the COG-PM intervention. To evaluate tolerability, reasons why participants were unable to complete COG-PM sessions in their entirety will be recorded. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function: global cognition | National Alzheimer's Coordinating Center Uniform Data Set: Montreal Cognitive Assessment; range: 0-30; higher scores indicate better performance | 7 days |
| Cognitive function: verbal working memory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya N Elias, PhD, MA, RN | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98104 | United States | ||
| University of Washington Medical Center |
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Prospective, randomized, experimental design
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Study personnel evaluating cognitive function outcomes will use standardized cognitive measures and will be blinded to participants' group assignments.
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| COG-PM | Behavioral | Participants who are randomized to the COG-PM intervention group will be asked to complete 30-minute computerized cognitive training (Lumosity cognitive training program) sessions during late afternoon/early evening hours (between 15:00-18:00), for a total of 7 days or until hospital discharge, whichever comes first. Participants will complete cognitive training sessions in each of the following subdomains: memory, attention, problem solving, cognitive flexibility, and processing speed. |
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National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Forward; number of correct trials, range: 0-14; higher scores indicate better performance
| 7 days |
| Cognitive function: executive function | National Alzheimer's Coordinating Center Uniform Data Set: Number Span Test Backward; number of correct trials, range: 0-14; higher scores indicate better performance | 7 days |
| Cognitive function: set-shifting | National Alzheimer's Coordinating Center Uniform Data Set: Oral Trail Making Test; time in seconds, range: 0-300; higher scores indicate worse performance | 7 days |
| Circadian rhythm of continuous body temperature | Circadian rhythm: amplitude, acrophase, mesor via continuous body temperature obtained from wearable sensors | 7 days |
| Activity counts per minute | Daytime activity: activity counts per minute during daytime hours via wrist actigraphy | 7 days |
| Total sleep time in minutes | Nighttime sleep: total sleep time in minutes during nighttime hours via wrist actigraphy | 7 days |
| Seattle |
| Washington |
| 98195 |
| United States |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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