Clinical Translational Science Institute (CTSI) Brain HQ Modules vs. Active Controls for Elderly Survivors of ICU

Study Overview
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Brief Summary
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The purpose of this project is to test whether an online cognitive rehabilitation program or online thinking exercises helps improve memory and thinking in elderly patients who survive a severe infection.

Detailed Description
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Currently, over 50% of patients are estimated to develop an Alzheimer's like disease following their hospitalization. This means they might have trouble remembering simple things or doing simple tasks. This can make returning to normal life difficult. This project will test whether online thinking exercises can help speed up patient's recovery.

Official Title
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Structured Cognitive Therapy to Improve Neurocognitive Dysfunction in Older Intensive Care Unit Sepsis Survivors

Conditions
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Neurocognitive Disorders

Intervention / Treatment
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* Behavioral: Brain HQ Cognitive Modules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the Intensive Care Unit (ICU) at Froedtert Memorial Lutheran Hospital (FMLH) Diagnosis of Sepsis Age 65 years or older Required mechanical ventilation or vasopressor therapy while in the ICU Had delirium while in the ICU Exclusion Criteria: Non-English Speaking Severe Dementia that would interfere with the ability to participate in the study activities Prior or current structural neurological injury that would confound study results Inability to communicate for any reason Current chemotherapy or radiation treatment Recent history of substance abuse Life expectancy < 6 months Planned discharge to long term acute care facility or nursing home Lack reliable access to the internet either through a computer or smart device

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain HQ adaptive Cognitive Therapy Modules<br>Brain HQ licensed modules that adapt to each individuals unique strengths and weaknesses to address deficits and improve neuroplasticity. | Behavioral: Brain HQ Cognitive Modules<br>* Online personalized cognitive therapy modules to address and improve neuroplasticity.<br>|
| Active Comparator: Brain HQ Active Control Modules<br>Participants in this arm will complete puzzles such as crossword puzzles, Sudoku, etc. | Behavioral: Brain HQ Cognitive Modules<br>* Online personalized cognitive therapy modules to address and improve neuroplasticity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tailored Online Cognitive Rehabilitation | Older survivors of sepsis will demonstrate > 80% adherence to a tailored cognitive rehabilitation program | 3 months | 
| Adherence to Online Intervention Modules | In recruited survivors of sepsis investigator will measure adherence to a facilitated structured neurocognitive rehabilitation program (administered as one-hour sessions, three days per week for 3 months) via a computer or smart device/phone. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Neurocognitive Function part 1 | A structured cognitive rehabilitation program will significantly improve neurocognitive function in older survivors of sepsis as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 40 - 160 scale measuring Immediate Memory, Visuospatial/Constructional, Language, Attention and Delayed Memory , Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test. | 6 months | 
| Improvement in Neurocognitive Function part 2 | A structured cognitive rehabilitation program will significantly improve neurocognitive function in older survivors of sepsis as measured by Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test and Symbol-Digit Modality Test measuring the duration it takes to complete the test. | 6 months | 
| Measure Differences in Cognitive Performance | Investigators will measure differences in cognitive performance at 3 and 6 months using the above mentioned tests in participants with active neurocognitive rehabilitation intervention as compared to controls. Consistent with the National Academy of Medicine recommendations the control group will receive an active intervention. This will include mind stimulating games such as Brain HQ crossword puzzles and Sudoku modules measuring the ability to complete and duration. | 6 months |