Clinical trial NCT04081090: Clinical Translational Science Institute (CTSI) Brain HQ Modules vs. Active Controls for Elderly Survivors of ICU
Official title: Structured Cognitive Therapy to Improve Neurocognitive Dysfunction in Older Intensive Care Unit Sepsis Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurocognitive Disorders
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 1
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tailored Online Cognitive Rehabilitation
timeFrame: 3 months
measure: Adherence to Online Intervention Modules
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in Neurocognitive Function part 1
timeFrame: 6 months
measure: Improvement in Neurocognitive Function part 2
timeFrame: 6 months
measure: Measure Differences in Cognitive Performance
timeFrame: 6 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Rahul Nanchal, MD, MS
role: PRINCIPAL_INVESTIGATOR
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