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

May 18, 2021 updated by: Rahul Nanchal, Medical College of Wisconsin

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tailored Online Cognitive Rehabilitation
Time Frame: 3 months
Older survivors of sepsis will demonstrate > 80% adherence to a tailored cognitive rehabilitation program
3 months
Adherence to Online Intervention Modules
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Neurocognitive Function part 1
Time Frame: 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.
6 months
Improvement in Neurocognitive Function part 2
Time Frame: 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.
6 months
Measure Differences in Cognitive Performance
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

August 26, 2020

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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