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

NCT04081090 | Terminated

• 1 other identifier: 32542
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders

Outcome Measures

Primary Outcomes (2)

• Tailored Online Cognitive Rehabilitation

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

  3 months

• 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.

  3 months

Secondary Outcomes (3)

• Improvement in Neurocognitive Function part 1

  6 months

• Improvement in Neurocognitive Function part 2

  6 months

• Measure Differences in Cognitive Performance

  6 months

Study Arms (2)

Brain HQ adaptive Cognitive Therapy Modules

EXPERIMENTAL

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

Behavioral: Brain HQ Cognitive Modules

Brain HQ Active Control Modules

ACTIVE COMPARATOR

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

Behavioral: Brain HQ Cognitive Modules

Interventions

Brain HQ Cognitive Modules BEHAVIORAL

Online personalized cognitive therapy modules to address and improve neuroplasticity.

Brain HQ Active Control Modules; Brain HQ adaptive Cognitive Therapy Modules

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (49)

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• McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.

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• Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.

  PMID: 15071384 BACKGROUND

• Almeida IC, Soares M, Bozza FA, Shinotsuka CR, Bujokas R, Souza-Dantas VC, Ely EW, Salluh JI. The impact of acute brain dysfunction in the outcomes of mechanically ventilated cancer patients. PLoS One. 2014 Jan 22;9(1):e85332. doi: 10.1371/journal.pone.0085332. eCollection 2014.

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  PMID: 22710202 BACKGROUND

• Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.

  PMID: 20473145 BACKGROUND

• Girard TD, Thompson JL, Pandharipande PP, Brummel NE, Jackson JC, Patel MB, Hughes CG, Chandrasekhar R, Pun BT, Boehm LM, Elstad MR, Goodman RB, Bernard GR, Dittus RS, Ely EW. Clinical phenotypes of delirium during critical illness and severity of subsequent long-term cognitive impairment: a prospective cohort study. Lancet Respir Med. 2018 Mar;6(3):213-222. doi: 10.1016/S2213-2600(18)30062-6.

  PMID: 29508705 BACKGROUND

• Wolters AE, van Dijk D, Pasma W, Cremer OL, Looije MF, de Lange DW, Veldhuijzen DS, Slooter AJ. Long-term outcome of delirium during intensive care unit stay in survivors of critical illness: a prospective cohort study. Crit Care. 2014 Jun 18;18(3):R125. doi: 10.1186/cc13929.

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  PMID: 21926597 BACKGROUND

• Jackson JC, Girard TD, Gordon SM, Thompson JL, Shintani AK, Thomason JW, Pun BT, Canonico AE, Dunn JG, Bernard GR, Dittus RS, Ely EW. Long-term cognitive and psychological outcomes in the awakening and breathing controlled trial. Am J Respir Crit Care Med. 2010 Jul 15;182(2):183-91. doi: 10.1164/rccm.200903-0442OC. Epub 2010 Mar 18.

  PMID: 20299535 BACKGROUND

• Needham DM, Dinglas VD, Morris PE, Jackson JC, Hough CL, Mendez-Tellez PA, Wozniak AW, Colantuoni E, Ely EW, Rice TW, Hopkins RO; NIH NHLBI ARDS Network. Physical and cognitive performance of patients with acute lung injury 1 year after initial trophic versus full enteral feeding. EDEN trial follow-up. Am J Respir Crit Care Med. 2013 Sep 1;188(5):567-76. doi: 10.1164/rccm.201304-0651OC.

  PMID: 23805899 BACKGROUND

• Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.

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• Morandi A, Rogers BP, Gunther ML, Merkle K, Pandharipande P, Girard TD, Jackson JC, Thompson J, Shintani AK, Geevarghese S, Miller RR 3rd, Canonico A, Cannistraci CJ, Gore JC, Ely EW, Hopkins RO; VISIONS Investigation, VISualizing Icu SurvivOrs Neuroradiological Sequelae. The relationship between delirium duration, white matter integrity, and cognitive impairment in intensive care unit survivors as determined by diffusion tensor imaging: the VISIONS prospective cohort magnetic resonance imaging study*. Crit Care Med. 2012 Jul;40(7):2182-9. doi: 10.1097/CCM.0b013e318250acdc.

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• van der Kooi AW, Slooter AJ, van Het Klooster MA, Leijten FS. EEG in delirium: Increased spectral variability and decreased complexity. Clin Neurophysiol. 2014 Oct;125(10):2137-9. doi: 10.1016/j.clinph.2014.02.010. Epub 2014 Feb 23. No abstract available.

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• van Dellen E, van der Kooi AW, Numan T, Koek HL, Klijn FA, Buijsrogge MP, Stam CJ, Slooter AJ. Decreased functional connectivity and disturbed directionality of information flow in the electroencephalography of intensive care unit patients with delirium after cardiac surgery. Anesthesiology. 2014 Aug;121(2):328-35. doi: 10.1097/ALN.0000000000000329.

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MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rahul Nanchal, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: September 9, 2019
• Study Start: January 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: August 26, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)