Cognitive Training for the Prevention of Postoperative Delirium

NCT02963961 | Completed

• 1 other identifier: HUM00119087
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium is a significant public health concern, affecting up to 70% of elderly patients presenting for surgery. Furthermore, postoperative delirium is associated with increased mortality, persistent cognitive decline, increased hospital length of stay, and elevated healthcare costs. Unfortunately, there is a lack of evidence-based strategies that consistently and effectively reduce the risk of delirium. In fact, although the American Geriatrics Society has released guidelines for the prevention of postoperative delirium, the evidence supporting many of the proposed preventive measures has been deemed low quality. Cognitive training exercises have been shown to improve cognitive function and functional status in community-dwelling elderly adults, and benefits may last for several months to years. Specifically, training exercises have led to improved performance in attention, short-term memory, and visuospatial processing; all of which are implicated as clinical features of delirium. Cognitive training has also strengthened connectivity in brain networks implicated in postoperative delirium. Thus, given these specific neurological benefits afforded, preoperative cognitive training may provide protection against the development of postoperative delirium. As such, the aim of this pilot study is to assess the feasibility of implementing a preoperative cognitive training program for surgical patients at high-risk for delirium and other associated complications.

Conditions

Delirium

Keywords

Delirium; Cognition; Prehabilitation; Neuroplasticity

Outcome Measures

Primary Outcomes (1)

• Percentage of Delirious Patients per Group

  Each participant who has experienced at least one episode of delirium by the postoperative day 3 time point, as determined by daily Confusion Assessment Method (CAM) screening, will then be calculated in each group to provide delirium incidence (%).

  By afternoon of postoperative day (POD) 3

Secondary Outcomes (6)

• Cognitive Function - Attention, Focus

  Baseline, immediate preoperative setting, and POD 3

• Cognitive Function - Memory

  Baseline, immediate preoperative setting, and POD 3

• Cognitive Function - Brain Processing Speed

  Baseline, immediate preoperative setting, and POD 3

• Hospital Length of Stay

  Length of hospital stay (n = number of days through study completion, up to 30 days) will be assessed in each group

• Length of ICU Stay

  Length of ICU stay (n = number of days through study completion, up to 30 days) will be assessed in each group

Other Outcomes (3)

• Pain Severity (1)

  PACU through POD3

• Pain Severity (2)

  PACU through POD3

• Postoperative Opioid Administration

  PACU through POD3

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Patients will engage in a daily preoperative cognitive training battery (BrainHQ, Posit Science) that aims to improve attention, memory, and visuospatial processing.

Behavioral: Preoperative Cognitive Training Battery

No Training

NO INTERVENTION

Patients will not undergo preoperative cognitive training. Patients will receive standard preoperative care.

Interventions

Preoperative Cognitive Training Battery BEHAVIORAL

Patients will engage in a daily preoperative cognitive training battery (BrainHQ, Posit Science) that aims to improve attention, memory, and visuospatial processing.

Cognitive Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 60 years of age and older
• Major noncardiac, non-major vascular, non-intracranial surgery
• Daily access to computer and internet use prior to surgery

You may not qualify if:

• Pre-existing cognitive impairment (preoperative delirium and/or not having capacity to provide informed consent)
• Severe auditory or visual impairment
• Emergency surgery
• No daily computer and internet access
• Already participating in cognitive training exercises

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Medical School

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (4)

• Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13.

  PMID: 24417410 BACKGROUND

• Kundu B, Sutterer DW, Emrich SM, Postle BR. Strengthened effective connectivity underlies transfer of working memory training to tests of short-term memory and attention. J Neurosci. 2013 May 15;33(20):8705-15. doi: 10.1523/JNEUROSCI.5565-12.2013.

  PMID: 23678114 BACKGROUND

• Zelinski EM, Spina LM, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Smith GE. Improvement in memory with plasticity-based adaptive cognitive training: results of the 3-month follow-up. J Am Geriatr Soc. 2011 Feb;59(2):258-65. doi: 10.1111/j.1532-5415.2010.03277.x.

  PMID: 21314646 BACKGROUND

• Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded.

  PMID: 23479546 BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Phillip E Vlisides, MD

  Department of Anesthesiology - University of Michigan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology, University of Michigan Medical School

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 15, 2016
• Study Start: April 6, 2017
• Primary Completion: May 18, 2018
• Study Completion: May 18, 2018
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

US (1)