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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04081090
Enrollment
1
Registered
2019-09-09
Start date
2019-01-15
Completion date
2020-08-26
Last updated
2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Disorders

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.

Interventions

BEHAVIORALBrain HQ Cognitive Modules

Online personalized cognitive therapy modules to address and improve neuroplasticity.

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Tailored Online Cognitive Rehabilitation3 monthsOlder survivors of sepsis will demonstrate \> 80% adherence to a tailored cognitive rehabilitation program
Adherence to Online Intervention Modules3 monthsIn 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

MeasureTime frameDescription
Improvement in Neurocognitive Function part 16 monthsA 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.
Improvement in Neurocognitive Function part 26 monthsA 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.
Measure Differences in Cognitive Performance6 monthsInvestigators 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026