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

Not Applicable

Terminated

• Conditions: Neurocognitive Disorders
• Interventions: Behavioral: Brain HQ Cognitive Modules

• Registration Number: NCT04081090
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-09
• Primary Completion: 2020-03-01
• Study Completion: 2020-08-26
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Admitted to the Intensive Care Unit (ICU) at Froedtert Memorial Lutheran Hospital (FMLH)
2. Diagnosis of Sepsis
3. Age 65 years or older
4. Required mechanical ventilation or vasopressor therapy while in the ICU
5. Had delirium while in the ICU

Exclusion Criteria

1. Non-English Speaking
2. Severe Dementia that would interfere with the ability to participate in the study activities
3. Prior or current structural neurological injury that would confound study results
4. Inability to communicate for any reason
5. Current chemotherapy or radiation treatment
6. Recent history of substance abuse
7. Life expectancy < 6 months
8. Planned discharge to long term acute care facility or nursing home
9. Lack reliable access to the internet either through a computer or smart device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brain HQ Active Control Modules	Brain HQ Cognitive Modules	Participants in this arm will complete puzzles such as crossword puzzles, Sudoku, etc.
Brain HQ adaptive Cognitive Therapy Modules	Brain HQ Cognitive Modules	Brain HQ licensed modules that adapt to each individuals unique strengths and weaknesses to address deficits and improve neuroplasticity.

Primary Outcome Measures

Name	Time	Method
Tailored Online Cognitive Rehabilitation	3 months	Older survivors of sepsis will demonstrate \> 80% adherence to a tailored cognitive rehabilitation program
Adherence to Online Intervention Modules	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in Neurocognitive Function part 2	6 months	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.
Improvement in Neurocognitive Function part 1	6 months	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.
Measure Differences in Cognitive Performance	6 months	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.

Trial Locations

Locations (1)

Froedtert Memorial Lutheran Hospital; 🇺🇸 Milwaukee, Wisconsin, United States