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

Primary Purpose

Neurocognitive Disorders

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brain HQ Cognitive Modules

About this trial

This is an interventional supportive care trial for Neurocognitive Disorders

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Froedtert Memorial Lutheran Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Brain HQ adaptive Cognitive Therapy Modules

Brain HQ Active Control Modules

Arm Description

Brain HQ licensed modules that adapt to each individuals unique strengths and weaknesses to address deficits and improve neuroplasticity.

Participants in this arm will complete puzzles such as crossword puzzles, Sudoku, etc.

Outcomes

Primary Outcome Measures

Tailored Online Cognitive Rehabilitation

Older survivors of sepsis will demonstrate > 80% adherence to a tailored cognitive rehabilitation program

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04081090

First Posted

April 30, 2019

Last Updated

May 18, 2021

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT04081090

Brief Title

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

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Delay due to COVID. Lost funding.

Study Start Date

January 15, 2019 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

August 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurocognitive Disorders

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brain HQ adaptive Cognitive Therapy Modules

Arm Type

Experimental

Arm Description

Brain HQ licensed modules that adapt to each individuals unique strengths and weaknesses to address deficits and improve neuroplasticity.

Arm Title

Brain HQ Active Control Modules

Arm Type

Active Comparator

Arm Description

Participants in this arm will complete puzzles such as crossword puzzles, Sudoku, etc.

Intervention Type

Behavioral

Intervention Name(s)

Brain HQ Cognitive Modules

Intervention Description

Online personalized cognitive therapy modules to address and improve neuroplasticity.

Primary Outcome Measure Information:

Title

Tailored Online Cognitive Rehabilitation

Description

Older survivors of sepsis will demonstrate > 80% adherence to a tailored cognitive rehabilitation program

Time Frame

3 months

Title

Adherence to Online Intervention Modules

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Improvement in Neurocognitive Function part 1

Description

Time Frame

6 months

Title

Improvement in Neurocognitive Function part 2

Description

Time Frame

6 months

Title

Measure Differences in Cognitive Performance

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rahul Nanchal, MD, MS

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Froedtert Memorial Lutheran Hospital

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share individual data collected as part of this project.

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

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